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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00144339
Registration number
NCT00144339
Ethics application status
Date submitted
2/09/2005
Date registered
5/09/2005
Date last updated
20/05/2014
Titles & IDs
Public title
Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).
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Secondary ID [1]
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205.235
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
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Assessment method [1]
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Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.
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Timepoint [1]
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From day 30 to 4 years
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Primary outcome [2]
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Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
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Assessment method [2]
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Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.
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Timepoint [2]
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From day 30 to 4 years
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Secondary outcome [1]
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Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
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Assessment method [1]
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Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1
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Timepoint [1]
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Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.
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Secondary outcome [2]
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Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
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Assessment method [2]
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Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1
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Timepoint [2]
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Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
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Secondary outcome [3]
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Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
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Assessment method [3]
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Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
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Timepoint [3]
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From day 30 to 4 years
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Secondary outcome [4]
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Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
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Assessment method [4]
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Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
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Timepoint [4]
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From day 30 to 4 years
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Secondary outcome [5]
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Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
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Assessment method [5]
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Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
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Timepoint [5]
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From day 30 to 4 years
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Secondary outcome [6]
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Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
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Assessment method [6]
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Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
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Timepoint [6]
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From day 30 to 4 years
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Secondary outcome [7]
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Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score
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Assessment method [7]
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SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health).
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Timepoint [7]
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From month 6 to 4 years
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Secondary outcome [8]
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Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
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Assessment method [8]
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Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
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Timepoint [8]
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Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.
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Secondary outcome [9]
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Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
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Assessment method [9]
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Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
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Timepoint [9]
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Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
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Secondary outcome [10]
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Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
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Assessment method [10]
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Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
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Timepoint [10]
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Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
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Secondary outcome [11]
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Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
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Assessment method [11]
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Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
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Timepoint [11]
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Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
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Secondary outcome [12]
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Time to First Exacerbation
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Assessment method [12]
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Chronic obstructive pulmonary disease (COPD) exacerbation
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Timepoint [12]
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From Day 1 to 4 years
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Secondary outcome [13]
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Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year
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Assessment method [13]
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Timepoint [13]
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Day 1 to 4 years
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Secondary outcome [14]
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Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
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Assessment method [14]
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Timepoint [14]
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Day 1 to 4 years
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Secondary outcome [15]
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Number of Exacerbation Days Per Patient Year
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Assessment method [15]
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Number of exacerbation days normalized by treatment exposure
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Timepoint [15]
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Day 1 to 4 years
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Secondary outcome [16]
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Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)
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Assessment method [16]
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0
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Timepoint [16]
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Day 1 to 4 years
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Secondary outcome [17]
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Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization
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Assessment method [17]
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Timepoint [17]
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From Day 1 to 4 years
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Secondary outcome [18]
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Number of Exacerbation Leading to Hospitalization
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Assessment method [18]
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Estimated number of exacerbations leading to hospitalizations per patient year
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Timepoint [18]
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From Day 1 to 4 years
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Secondary outcome [19]
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Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization
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Assessment method [19]
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Number of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure)
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Timepoint [19]
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From Day 1 to 4 years
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Secondary outcome [20]
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Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
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Assessment method [20]
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Estimated FEV1 before bronchodilator at Month 1
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Timepoint [20]
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Month 1
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Secondary outcome [21]
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Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
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Assessment method [21]
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Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1
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Timepoint [21]
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Month 1
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Secondary outcome [22]
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Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
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Assessment method [22]
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Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6
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Timepoint [22]
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Month 6
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Secondary outcome [23]
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0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
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Assessment method [23]
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0
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Timepoint [23]
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Month 6
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Secondary outcome [24]
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Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
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Assessment method [24]
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0
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Timepoint [24]
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Month 12
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Secondary outcome [25]
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Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
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Assessment method [25]
0
0
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Timepoint [25]
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Month 12
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Secondary outcome [26]
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0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
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Assessment method [26]
0
0
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Timepoint [26]
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Month 18
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Secondary outcome [27]
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0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
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Assessment method [27]
0
0
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Timepoint [27]
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Month 18
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Secondary outcome [28]
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0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
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Assessment method [28]
0
0
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Timepoint [28]
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0
Month 24
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Secondary outcome [29]
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0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
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Assessment method [29]
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0
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Timepoint [29]
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Month 24
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Secondary outcome [30]
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Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
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Assessment method [30]
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0
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Timepoint [30]
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Month 30
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Secondary outcome [31]
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Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
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Assessment method [31]
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0
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Timepoint [31]
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Month 30
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Secondary outcome [32]
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Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
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Assessment method [32]
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0
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Timepoint [32]
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Month 36
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Secondary outcome [33]
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Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
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Assessment method [33]
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0
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Timepoint [33]
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Month 36
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Secondary outcome [34]
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Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
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Assessment method [34]
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0
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Timepoint [34]
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Month 42
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Secondary outcome [35]
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0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
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Assessment method [35]
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Estimated FEV1 after bronchodilator at Month 42
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Timepoint [35]
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Month 42
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Secondary outcome [36]
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0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
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Assessment method [36]
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0
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Timepoint [36]
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Month 48
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Secondary outcome [37]
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0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
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Assessment method [37]
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0
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Timepoint [37]
0
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Month 48
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Secondary outcome [38]
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Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1
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Assessment method [38]
0
0
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Timepoint [38]
0
0
Month 1
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Secondary outcome [39]
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Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1
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Assessment method [39]
0
0
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Timepoint [39]
0
0
Month 1
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Secondary outcome [40]
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0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6
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Assessment method [40]
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0
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Timepoint [40]
0
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Month 6
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Secondary outcome [41]
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Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6
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Assessment method [41]
0
0
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Timepoint [41]
0
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Month 6
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Secondary outcome [42]
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0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12
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Assessment method [42]
0
0
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Timepoint [42]
0
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Month 12
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Secondary outcome [43]
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0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12
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Assessment method [43]
0
0
Query!
Timepoint [43]
0
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Month 12
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Secondary outcome [44]
0
0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18
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Assessment method [44]
0
0
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Timepoint [44]
0
0
Month 18
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Secondary outcome [45]
0
0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18
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Assessment method [45]
0
0
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Timepoint [45]
0
0
Month 18
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Secondary outcome [46]
0
0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24
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Assessment method [46]
0
0
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Timepoint [46]
0
0
Month 24
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Secondary outcome [47]
0
0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24
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Assessment method [47]
0
0
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Timepoint [47]
0
0
Month 24
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Secondary outcome [48]
0
0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30
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Assessment method [48]
0
0
Query!
Timepoint [48]
0
0
Month 30
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Secondary outcome [49]
0
0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30
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Assessment method [49]
0
0
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Timepoint [49]
0
0
Month 30
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Secondary outcome [50]
0
0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36
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Assessment method [50]
0
0
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Timepoint [50]
0
0
Month 36
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Secondary outcome [51]
0
0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36
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Assessment method [51]
0
0
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Timepoint [51]
0
0
Month 36
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Secondary outcome [52]
0
0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42
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Assessment method [52]
0
0
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Timepoint [52]
0
0
Month 42
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Secondary outcome [53]
0
0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42
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Assessment method [53]
0
0
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Timepoint [53]
0
0
Month 42
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Secondary outcome [54]
0
0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48
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Assessment method [54]
0
0
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Timepoint [54]
0
0
Month 48
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Secondary outcome [55]
0
0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48
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Assessment method [55]
0
0
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Timepoint [55]
0
0
Month 48
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Secondary outcome [56]
0
0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1
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Assessment method [56]
0
0
Query!
Timepoint [56]
0
0
Month 1
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Secondary outcome [57]
0
0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1
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Assessment method [57]
0
0
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Timepoint [57]
0
0
Month 1
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Secondary outcome [58]
0
0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6
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Assessment method [58]
0
0
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Timepoint [58]
0
0
Month 6
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Secondary outcome [59]
0
0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6
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Assessment method [59]
0
0
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Timepoint [59]
0
0
Month 6
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Secondary outcome [60]
0
0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12
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Assessment method [60]
0
0
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Timepoint [60]
0
0
Month 12
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Secondary outcome [61]
0
0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12
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Assessment method [61]
0
0
Query!
Timepoint [61]
0
0
Month 12
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Secondary outcome [62]
0
0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18
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Assessment method [62]
0
0
Query!
Timepoint [62]
0
0
Month 18
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Secondary outcome [63]
0
0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18
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Assessment method [63]
0
0
Query!
Timepoint [63]
0
0
Month 18
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Secondary outcome [64]
0
0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24
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Assessment method [64]
0
0
Query!
Timepoint [64]
0
0
Month 24
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Secondary outcome [65]
0
0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24
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Assessment method [65]
0
0
Query!
Timepoint [65]
0
0
Month 24
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Secondary outcome [66]
0
0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30
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Assessment method [66]
0
0
Query!
Timepoint [66]
0
0
Month 30
Query!
Secondary outcome [67]
0
0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30
Query!
Assessment method [67]
0
0
Query!
Timepoint [67]
0
0
Month 30
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Secondary outcome [68]
0
0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36
Query!
Assessment method [68]
0
0
Query!
Timepoint [68]
0
0
Month 36
Query!
Secondary outcome [69]
0
0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36
Query!
Assessment method [69]
0
0
Query!
Timepoint [69]
0
0
Month 36
Query!
Secondary outcome [70]
0
0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42
Query!
Assessment method [70]
0
0
Query!
Timepoint [70]
0
0
Month 42
Query!
Secondary outcome [71]
0
0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42
Query!
Assessment method [71]
0
0
Query!
Timepoint [71]
0
0
Month 42
Query!
Secondary outcome [72]
0
0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48
Query!
Assessment method [72]
0
0
Query!
Timepoint [72]
0
0
Month 48
Query!
Secondary outcome [73]
0
0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48
Query!
Assessment method [73]
0
0
Query!
Timepoint [73]
0
0
Month 48
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Secondary outcome [74]
0
0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6
Query!
Assessment method [74]
0
0
* SGRQ total score summarizes the impact of COPD on overall patient's health status.
* Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
* The scale is continuous.
* Rate of decline shows the yearly change of SGRQ total score.
Query!
Timepoint [74]
0
0
Month 6
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Secondary outcome [75]
0
0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12
Query!
Assessment method [75]
0
0
* SGRQ total score summarizes the impact of COPD on overall patient's health status.
* Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
* The scale is continuous.
* Rate of decline shows the yearly change of SGRQ total score.
Query!
Timepoint [75]
0
0
Month 12
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Secondary outcome [76]
0
0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18
Query!
Assessment method [76]
0
0
* SGRQ total score summarizes the impact of COPD on overall patient's health status.
* Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
* The scale is continuous.
* Rate of decline shows the yearly change of SGRQ total score.
Query!
Timepoint [76]
0
0
Month 18
Query!
Secondary outcome [77]
0
0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24
Query!
Assessment method [77]
0
0
* SGRQ total score summarizes the impact of COPD on overall patient's health status.
* Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
* The scale is continuous.
* Rate of decline shows the yearly change of SGRQ total score.
Query!
Timepoint [77]
0
0
Month 24
Query!
Secondary outcome [78]
0
0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30
Query!
Assessment method [78]
0
0
* SGRQ total score summarizes the impact of COPD on overall patient's health status.
* Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
* The scale is continuous.
* Rate of decline shows the yearly change of SGRQ total score.
Query!
Timepoint [78]
0
0
Month 30
Query!
Secondary outcome [79]
0
0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36
Query!
Assessment method [79]
0
0
* SGRQ total score summarizes the impact of COPD on overall patient's health status.
* Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
* The scale is continuous.
* Rate of decline shows the yearly change of SGRQ total score.
Query!
Timepoint [79]
0
0
Month 36
Query!
Secondary outcome [80]
0
0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42
Query!
Assessment method [80]
0
0
* SGRQ total score summarizes the impact of COPD on overall patient's health status.
* Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
* The scale is continuous.
* Rate of decline shows the yearly change of SGRQ total score.
Query!
Timepoint [80]
0
0
Month 42
Query!
Secondary outcome [81]
0
0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48
Query!
Assessment method [81]
0
0
* SGRQ total score summarizes the impact of COPD on overall patient's health status.
* Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
* The scale is continuous.
* Rate of decline shows the yearly change of SGRQ total score.
Query!
Timepoint [81]
0
0
Month 48
Query!
Secondary outcome [82]
0
0
Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)
Query!
Assessment method [82]
0
0
On-treatment defined as day 1 to completion of double blinded treatment plus 30 days
Query!
Timepoint [82]
0
0
Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days
Query!
Secondary outcome [83]
0
0
Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)
Query!
Assessment method [83]
0
0
All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used.
Query!
Timepoint [83]
0
0
Day 1 to day 1470
Query!
Secondary outcome [84]
0
0
Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)
Query!
Assessment method [84]
0
0
The primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days
Query!
Timepoint [84]
0
0
Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days
Query!
Secondary outcome [85]
0
0
Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)
Query!
Assessment method [85]
0
0
The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used
Query!
Timepoint [85]
0
0
Day 1 to day 1470
Query!
Eligibility
Key inclusion criteria
* Written informed consent.
* Male or female patients 40 years of age or older.
* Smoking history of at least 10 pack years.
* Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1<70% of FVC and on stable respiratory medication.
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.
* Myocardial infarction in past 6 months.
* Unstable or life threatening arrhythmia in past year.
* Hospitalization for NYHA heart failure class III or IV in past year.
* Active tuberculosis.
* Asthma.
* Pulmonary resection.
* Malignancy treated with radiation or chemotherapy in past 5 years.
* Respiratory infection in 4 weeks prior to screening.
* Known hypersensitivity to anticholinergic drugs or components.
* Known moderate to severe renal impairment.
* Known narrow angle glaucoma.
* Significant symptomatic BPH or bladder neck obstruction.
* Need for oxygen therapy >12 hr/day.
* Use of oral corticosteroids at unstable doses or >10 mg/day.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/12/2002
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
5993
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
205.235.0205 Boehringer Ingelheim Investigational Site - Bankstown
Query!
Recruitment hospital [2]
0
0
205.235.0202 Boehringer Ingelheim Investigational Site - Concord
Query!
Recruitment hospital [3]
0
0
205.235.0209 Boehringer Ingelheim Investigational Site - Westmead
Query!
Recruitment hospital [4]
0
0
205.235.0204 Boehringer Ingelheim Investigational Site - Cairns
Query!
Recruitment hospital [5]
0
0
205.235.0203 Boehringer Ingelheim Investigational Site - Redcliffe
Query!
Recruitment hospital [6]
0
0
205.235.0207 Boehringer Ingelheim Investigational Site - Port Lincoln
Query!
Recruitment hospital [7]
0
0
205.235.0206 Boehringer Ingelheim Investigational Site - Box Hill
Query!
Recruitment hospital [8]
0
0
205.235.0201 Boehringer Ingelheim Investigational Site - Geelong
Query!
Recruitment postcode(s) [1]
0
0
- Bankstown
Query!
Recruitment postcode(s) [2]
0
0
- Concord
Query!
Recruitment postcode(s) [3]
0
0
- Westmead
Query!
Recruitment postcode(s) [4]
0
0
- Cairns
Query!
Recruitment postcode(s) [5]
0
0
- Redcliffe
Query!
Recruitment postcode(s) [6]
0
0
- Port Lincoln
Query!
Recruitment postcode(s) [7]
0
0
- Box Hill
Query!
Recruitment postcode(s) [8]
0
0
- Geelong
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Iowa
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kansas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Kentucky
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Louisiana
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Maine
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Maryland
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Massachusetts
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Michigan
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Minnesota
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Missouri
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New Hampshire
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
New Jersey
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
New York
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
North Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Ohio
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Oklahoma
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Oregon
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Pennsylvania
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Rhode Island
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Texas
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Utah
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Virginia
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Washington
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Wisconsin
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Buenos Aires
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Capital Federal
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
Parque Velez Sarlfield
Query!
Country [38]
0
0
Argentina
Query!
State/province [38]
0
0
Rosario
Query!
Country [39]
0
0
Argentina
Query!
State/province [39]
0
0
Vicente López
Query!
Country [40]
0
0
Austria
Query!
State/province [40]
0
0
Graz
Query!
Country [41]
0
0
Austria
Query!
State/province [41]
0
0
Innsbruck
Query!
Country [42]
0
0
Austria
Query!
State/province [42]
0
0
Leoben
Query!
Country [43]
0
0
Austria
Query!
State/province [43]
0
0
Wien
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Anderlecht
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Baudour
Query!
Country [46]
0
0
Belgium
Query!
State/province [46]
0
0
Brugge
Query!
Country [47]
0
0
Belgium
Query!
State/province [47]
0
0
Brussel
Query!
Country [48]
0
0
Belgium
Query!
State/province [48]
0
0
Bruxelles
Query!
Country [49]
0
0
Belgium
Query!
State/province [49]
0
0
Dendermonde
Query!
Country [50]
0
0
Belgium
Query!
State/province [50]
0
0
Edegem
Query!
Country [51]
0
0
Belgium
Query!
State/province [51]
0
0
Gent
Query!
Country [52]
0
0
Belgium
Query!
State/province [52]
0
0
Herentals
Query!
Country [53]
0
0
Belgium
Query!
State/province [53]
0
0
Ieper
Query!
Country [54]
0
0
Belgium
Query!
State/province [54]
0
0
Kortrijk
Query!
Country [55]
0
0
Belgium
Query!
State/province [55]
0
0
Leuven
Query!
Country [56]
0
0
Belgium
Query!
State/province [56]
0
0
Luxembourg
Query!
Country [57]
0
0
Belgium
Query!
State/province [57]
0
0
Menen
Query!
Country [58]
0
0
Belgium
Query!
State/province [58]
0
0
Merksem
Query!
Country [59]
0
0
Belgium
Query!
State/province [59]
0
0
Middelheim
Query!
Country [60]
0
0
Belgium
Query!
State/province [60]
0
0
Mons
Query!
Country [61]
0
0
Belgium
Query!
State/province [61]
0
0
Namur
Query!
Country [62]
0
0
Belgium
Query!
State/province [62]
0
0
Neerpelt
Query!
Country [63]
0
0
Belgium
Query!
State/province [63]
0
0
Nobressart (ATTERT)
Query!
Country [64]
0
0
Belgium
Query!
State/province [64]
0
0
Oostende
Query!
Country [65]
0
0
Belgium
Query!
State/province [65]
0
0
Tournai
Query!
Country [66]
0
0
Belgium
Query!
State/province [66]
0
0
Turnhout
Query!
Country [67]
0
0
Belgium
Query!
State/province [67]
0
0
Yvoir
Query!
Country [68]
0
0
Brazil
Query!
State/province [68]
0
0
Florianópolis - SC
Query!
Country [69]
0
0
Brazil
Query!
State/province [69]
0
0
Juiz de Fora - MG
Query!
Country [70]
0
0
Brazil
Query!
State/province [70]
0
0
Porto Alegre - RS
Query!
Country [71]
0
0
Brazil
Query!
State/province [71]
0
0
Rio de Janeiro - RJ
Query!
Country [72]
0
0
Brazil
Query!
State/province [72]
0
0
Salvador - BA
Query!
Country [73]
0
0
Brazil
Query!
State/province [73]
0
0
Santo André - SP
Query!
Country [74]
0
0
Brazil
Query!
State/province [74]
0
0
São Paulo - SP
Query!
Country [75]
0
0
Czech Republic
Query!
State/province [75]
0
0
Benesov
Query!
Country [76]
0
0
Czech Republic
Query!
State/province [76]
0
0
Beroun
Query!
Country [77]
0
0
Czech Republic
Query!
State/province [77]
0
0
Brno
Query!
Country [78]
0
0
Czech Republic
Query!
State/province [78]
0
0
Cesky Tesin
Query!
Country [79]
0
0
Czech Republic
Query!
State/province [79]
0
0
Hradec Kralove
Query!
Country [80]
0
0
Czech Republic
Query!
State/province [80]
0
0
Jablonec nad Nisou
Query!
Country [81]
0
0
Czech Republic
Query!
State/province [81]
0
0
Jaromer
Query!
Country [82]
0
0
Czech Republic
Query!
State/province [82]
0
0
Kromeriz
Query!
Country [83]
0
0
Czech Republic
Query!
State/province [83]
0
0
Kyjov
Query!
Country [84]
0
0
Czech Republic
Query!
State/province [84]
0
0
Lovosice
Query!
Country [85]
0
0
Czech Republic
Query!
State/province [85]
0
0
Marianske Lazne
Query!
Country [86]
0
0
Czech Republic
Query!
State/province [86]
0
0
Plzen
Query!
Country [87]
0
0
Czech Republic
Query!
State/province [87]
0
0
Prague 5
Query!
Country [88]
0
0
Czech Republic
Query!
State/province [88]
0
0
Praha 4
Query!
Country [89]
0
0
Czech Republic
Query!
State/province [89]
0
0
Praha 5 - Nove Butovice
Query!
Country [90]
0
0
Czech Republic
Query!
State/province [90]
0
0
Praha 5
Query!
Country [91]
0
0
Czech Republic
Query!
State/province [91]
0
0
Praha 8
Query!
Country [92]
0
0
Czech Republic
Query!
State/province [92]
0
0
Prerov
Query!
Country [93]
0
0
Czech Republic
Query!
State/province [93]
0
0
Pribor
Query!
Country [94]
0
0
Czech Republic
Query!
State/province [94]
0
0
Strakonice
Query!
Country [95]
0
0
Czech Republic
Query!
State/province [95]
0
0
Tabor
Query!
Country [96]
0
0
Czech Republic
Query!
State/province [96]
0
0
Usti nad Orlici
Query!
Country [97]
0
0
Czech Republic
Query!
State/province [97]
0
0
Znojmo
Query!
Country [98]
0
0
Denmark
Query!
State/province [98]
0
0
Aalborg SV
Query!
Country [99]
0
0
Denmark
Query!
State/province [99]
0
0
Aalborg
Query!
Country [100]
0
0
Denmark
Query!
State/province [100]
0
0
Aarhus
Query!
Country [101]
0
0
Denmark
Query!
State/province [101]
0
0
Copenhagen K
Query!
Country [102]
0
0
Denmark
Query!
State/province [102]
0
0
Copenhagen NV
Query!
Country [103]
0
0
Denmark
Query!
State/province [103]
0
0
Copenhagen
Query!
Country [104]
0
0
Denmark
Query!
State/province [104]
0
0
Frederikshavn
Query!
Country [105]
0
0
Denmark
Query!
State/province [105]
0
0
Frederikssund
Query!
Country [106]
0
0
Denmark
Query!
State/province [106]
0
0
Fåborg
Query!
Country [107]
0
0
Denmark
Query!
State/province [107]
0
0
Hellerup
Query!
Country [108]
0
0
Denmark
Query!
State/province [108]
0
0
Helsingor
Query!
Country [109]
0
0
Denmark
Query!
State/province [109]
0
0
Hillerød
Query!
Country [110]
0
0
Denmark
Query!
State/province [110]
0
0
Hobro
Query!
Country [111]
0
0
Denmark
Query!
State/province [111]
0
0
Holbæk
Query!
Country [112]
0
0
Denmark
Query!
State/province [112]
0
0
Holstebro
Query!
Country [113]
0
0
Denmark
Query!
State/province [113]
0
0
Hvidovre
Query!
Country [114]
0
0
Denmark
Query!
State/province [114]
0
0
Kalundborg
Query!
Country [115]
0
0
Denmark
Query!
State/province [115]
0
0
Kolding
Query!
Country [116]
0
0
Denmark
Query!
State/province [116]
0
0
Nykobing F.
Query!
Country [117]
0
0
Denmark
Query!
State/province [117]
0
0
Næstved
Query!
Country [118]
0
0
Denmark
Query!
State/province [118]
0
0
Odense C
Query!
Country [119]
0
0
Denmark
Query!
State/province [119]
0
0
Randers
Query!
Country [120]
0
0
Denmark
Query!
State/province [120]
0
0
Silkeborg
Query!
Country [121]
0
0
Denmark
Query!
State/province [121]
0
0
Skive
Query!
Country [122]
0
0
Denmark
Query!
State/province [122]
0
0
Slagelse
Query!
Country [123]
0
0
Denmark
Query!
State/province [123]
0
0
Svendborg
Query!
Country [124]
0
0
Denmark
Query!
State/province [124]
0
0
Værløse
Query!
Country [125]
0
0
Finland
Query!
State/province [125]
0
0
Helsinki
Query!
Country [126]
0
0
Finland
Query!
State/province [126]
0
0
Jyväskylä
Query!
Country [127]
0
0
Finland
Query!
State/province [127]
0
0
Kotka
Query!
Country [128]
0
0
Finland
Query!
State/province [128]
0
0
Lahti
Query!
Country [129]
0
0
Finland
Query!
State/province [129]
0
0
Pori
Query!
Country [130]
0
0
France
Query!
State/province [130]
0
0
Albi cedex 9
Query!
Country [131]
0
0
France
Query!
State/province [131]
0
0
Albi
Query!
Country [132]
0
0
France
Query!
State/province [132]
0
0
Barbezieux St Hilaire
Query!
Country [133]
0
0
France
Query!
State/province [133]
0
0
Bourges
Query!
Country [134]
0
0
France
Query!
State/province [134]
0
0
Chamalières
Query!
Country [135]
0
0
France
Query!
State/province [135]
0
0
Chauny cedex
Query!
Country [136]
0
0
France
Query!
State/province [136]
0
0
Cholet
Query!
Country [137]
0
0
France
Query!
State/province [137]
0
0
La Teste
Query!
Country [138]
0
0
France
Query!
State/province [138]
0
0
Marseille
Query!
Country [139]
0
0
France
Query!
State/province [139]
0
0
Montauban
Query!
Country [140]
0
0
France
Query!
State/province [140]
0
0
Nantes
Query!
Country [141]
0
0
France
Query!
State/province [141]
0
0
Nice
Query!
Country [142]
0
0
France
Query!
State/province [142]
0
0
Paris
Query!
Country [143]
0
0
France
Query!
State/province [143]
0
0
Provins
Query!
Country [144]
0
0
France
Query!
State/province [144]
0
0
Strasbourg
Query!
Country [145]
0
0
France
Query!
State/province [145]
0
0
Tarbes cedex 9
Query!
Country [146]
0
0
France
Query!
State/province [146]
0
0
Toulouse
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Berlin
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Brake
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Braunschweig
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Bruchsal
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Hannover
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Kaufbeuren
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Lörrach
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Lübeck
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
München
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Ulm
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Weyhe
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Wiesloch
Query!
Country [159]
0
0
Greece
Query!
State/province [159]
0
0
Athens
Query!
Country [160]
0
0
Greece
Query!
State/province [160]
0
0
Heraklion
Query!
Country [161]
0
0
Greece
Query!
State/province [161]
0
0
Kavala
Query!
Country [162]
0
0
Greece
Query!
State/province [162]
0
0
Larissa
Query!
Country [163]
0
0
Greece
Query!
State/province [163]
0
0
Patra
Query!
Country [164]
0
0
Greece
Query!
State/province [164]
0
0
Thessaloniki
Query!
Country [165]
0
0
Hong Kong
Query!
State/province [165]
0
0
Hong Kong
Query!
Country [166]
0
0
Hong Kong
Query!
State/province [166]
0
0
Kowloon
Query!
Country [167]
0
0
Hungary
Query!
State/province [167]
0
0
Budapest
Query!
Country [168]
0
0
Hungary
Query!
State/province [168]
0
0
Debrecen
Query!
Country [169]
0
0
Hungary
Query!
State/province [169]
0
0
Deszk
Query!
Country [170]
0
0
Hungary
Query!
State/province [170]
0
0
Erd
Query!
Country [171]
0
0
Hungary
Query!
State/province [171]
0
0
Farkasgyepü
Query!
Country [172]
0
0
Hungary
Query!
State/province [172]
0
0
Gyula
Query!
Country [173]
0
0
Hungary
Query!
State/province [173]
0
0
Kiskunhalas
Query!
Country [174]
0
0
Hungary
Query!
State/province [174]
0
0
Miskolc
Query!
Country [175]
0
0
Hungary
Query!
State/province [175]
0
0
Mosonmagyarovar
Query!
Country [176]
0
0
Hungary
Query!
State/province [176]
0
0
Pecs
Query!
Country [177]
0
0
Hungary
Query!
State/province [177]
0
0
Solymar
Query!
Country [178]
0
0
Hungary
Query!
State/province [178]
0
0
Sopron
Query!
Country [179]
0
0
Hungary
Query!
State/province [179]
0
0
Szombathely
Query!
Country [180]
0
0
Hungary
Query!
State/province [180]
0
0
Tatabanya
Query!
Country [181]
0
0
Hungary
Query!
State/province [181]
0
0
Törökbalint
Query!
Country [182]
0
0
Hungary
Query!
State/province [182]
0
0
Veszprem
Query!
Country [183]
0
0
Ireland
Query!
State/province [183]
0
0
Dublin 15
Query!
Country [184]
0
0
Ireland
Query!
State/province [184]
0
0
Dublin 4
Query!
Country [185]
0
0
Ireland
Query!
State/province [185]
0
0
Dublin 9
Query!
Country [186]
0
0
Italy
Query!
State/province [186]
0
0
Alessandria
Query!
Country [187]
0
0
Italy
Query!
State/province [187]
0
0
Avellino
Query!
Country [188]
0
0
Italy
Query!
State/province [188]
0
0
Bologna
Query!
Country [189]
0
0
Italy
Query!
State/province [189]
0
0
Busto Arsizio (VA)
Query!
Country [190]
0
0
Italy
Query!
State/province [190]
0
0
Cagliari
Query!
Country [191]
0
0
Italy
Query!
State/province [191]
0
0
Carrara (Massa)
Query!
Country [192]
0
0
Italy
Query!
State/province [192]
0
0
CASSANO D'ADDA (Milano)
Query!
Country [193]
0
0
Italy
Query!
State/province [193]
0
0
Chieti
Query!
Country [194]
0
0
Italy
Query!
State/province [194]
0
0
Erice (Trapani)
Query!
Country [195]
0
0
Italy
Query!
State/province [195]
0
0
Ferrara
Query!
Country [196]
0
0
Italy
Query!
State/province [196]
0
0
Firenze
Query!
Country [197]
0
0
Italy
Query!
State/province [197]
0
0
Genova
Query!
Country [198]
0
0
Italy
Query!
State/province [198]
0
0
Gubbio (Perugia)
Query!
Country [199]
0
0
Italy
Query!
State/province [199]
0
0
Iglesias (Cagliari)
Query!
Country [200]
0
0
Italy
Query!
State/province [200]
0
0
L'Aquila
Query!
Country [201]
0
0
Italy
Query!
State/province [201]
0
0
Macerata
Query!
Country [202]
0
0
Italy
Query!
State/province [202]
0
0
Milano
Query!
Country [203]
0
0
Italy
Query!
State/province [203]
0
0
Modica (Ragusa)
Query!
Country [204]
0
0
Italy
Query!
State/province [204]
0
0
Orbassano (Torino)
Query!
Country [205]
0
0
Italy
Query!
State/province [205]
0
0
Perugia
Query!
Country [206]
0
0
Italy
Query!
State/province [206]
0
0
Pisa
Query!
Country [207]
0
0
Italy
Query!
State/province [207]
0
0
Pordenone
Query!
Country [208]
0
0
Italy
Query!
State/province [208]
0
0
Prato
Query!
Country [209]
0
0
Italy
Query!
State/province [209]
0
0
Sassari
Query!
Country [210]
0
0
Italy
Query!
State/province [210]
0
0
Terni
Query!
Country [211]
0
0
Italy
Query!
State/province [211]
0
0
Torino
Query!
Country [212]
0
0
Italy
Query!
State/province [212]
0
0
Torrette di Ancona (Ancona)
Query!
Country [213]
0
0
Italy
Query!
State/province [213]
0
0
Treviso
Query!
Country [214]
0
0
Italy
Query!
State/province [214]
0
0
Voghera (Pavia)
Query!
Country [215]
0
0
Japan
Query!
State/province [215]
0
0
Bunkyo-ku, Tokyo
Query!
Country [216]
0
0
Japan
Query!
State/province [216]
0
0
Kamogawa, Chiba
Query!
Country [217]
0
0
Japan
Query!
State/province [217]
0
0
Komaki, Aichi
Query!
Country [218]
0
0
Japan
Query!
State/province [218]
0
0
Kurume, Fukuoka
Query!
Country [219]
0
0
Japan
Query!
State/province [219]
0
0
Matsumoto, Nagano
Query!
Country [220]
0
0
Japan
Query!
State/province [220]
0
0
Morioka, Iwate
Query!
Country [221]
0
0
Japan
Query!
State/province [221]
0
0
Osaka, Osaka
Query!
Country [222]
0
0
Japan
Query!
State/province [222]
0
0
Osakasayama, Osaka
Query!
Country [223]
0
0
Japan
Query!
State/province [223]
0
0
Sapporo, Hokkaido
Query!
Country [224]
0
0
Japan
Query!
State/province [224]
0
0
Sendai, Miyagi
Query!
Country [225]
0
0
Japan
Query!
State/province [225]
0
0
Seto, Aichi
Query!
Country [226]
0
0
Japan
Query!
State/province [226]
0
0
Yokote, Akita
Query!
Country [227]
0
0
Lithuania
Query!
State/province [227]
0
0
Kaunas
Query!
Country [228]
0
0
Lithuania
Query!
State/province [228]
0
0
Vilnius
Query!
Country [229]
0
0
Malaysia
Query!
State/province [229]
0
0
Kuala Lumpur
Query!
Country [230]
0
0
Mexico
Query!
State/province [230]
0
0
Ciudad de Mexico
Query!
Country [231]
0
0
Mexico
Query!
State/province [231]
0
0
Col. Mitras Centro, Monterrey, N.L.
Query!
Country [232]
0
0
Mexico
Query!
State/province [232]
0
0
Guadalajara, Jal.
Query!
Country [233]
0
0
Mexico
Query!
State/province [233]
0
0
Puebla
Query!
Country [234]
0
0
Mexico
Query!
State/province [234]
0
0
Toluca
Query!
Country [235]
0
0
Mexico
Query!
State/province [235]
0
0
Zapopan, jalisco
Query!
Country [236]
0
0
Netherlands
Query!
State/province [236]
0
0
Almelo
Query!
Country [237]
0
0
Netherlands
Query!
State/province [237]
0
0
Amersfoort
Query!
Country [238]
0
0
Netherlands
Query!
State/province [238]
0
0
Delft
Query!
Country [239]
0
0
Netherlands
Query!
State/province [239]
0
0
Dordrecht
Query!
Country [240]
0
0
Netherlands
Query!
State/province [240]
0
0
Eindhoven
Query!
Country [241]
0
0
Netherlands
Query!
State/province [241]
0
0
Groningen
Query!
Country [242]
0
0
Netherlands
Query!
State/province [242]
0
0
Harderwijk
Query!
Country [243]
0
0
Netherlands
Query!
State/province [243]
0
0
Heerenveen
Query!
Country [244]
0
0
Netherlands
Query!
State/province [244]
0
0
Heerlen
Query!
Country [245]
0
0
Netherlands
Query!
State/province [245]
0
0
Hengelo
Query!
Country [246]
0
0
Netherlands
Query!
State/province [246]
0
0
Leeuwarden
Query!
Country [247]
0
0
Netherlands
Query!
State/province [247]
0
0
Rotterdam
Query!
Country [248]
0
0
Netherlands
Query!
State/province [248]
0
0
Sneek
Query!
Country [249]
0
0
New Zealand
Query!
State/province [249]
0
0
Auckland
Query!
Country [250]
0
0
New Zealand
Query!
State/province [250]
0
0
Christchurch, New Zealand
Query!
Country [251]
0
0
Norway
Query!
State/province [251]
0
0
Arendal
Query!
Country [252]
0
0
Norway
Query!
State/province [252]
0
0
Fredrikstad
Query!
Country [253]
0
0
Norway
Query!
State/province [253]
0
0
Sandvika
Query!
Country [254]
0
0
Norway
Query!
State/province [254]
0
0
Straume
Query!
Country [255]
0
0
Philippines
Query!
State/province [255]
0
0
Manila
Query!
Country [256]
0
0
Philippines
Query!
State/province [256]
0
0
Quezon City
Query!
Country [257]
0
0
Poland
Query!
State/province [257]
0
0
Gdansk
Query!
Country [258]
0
0
Poland
Query!
State/province [258]
0
0
Katowice
Query!
Country [259]
0
0
Poland
Query!
State/province [259]
0
0
Krakow
Query!
Country [260]
0
0
Poland
Query!
State/province [260]
0
0
Lodz
Query!
Country [261]
0
0
Poland
Query!
State/province [261]
0
0
Warsaw
Query!
Country [262]
0
0
Poland
Query!
State/province [262]
0
0
Wroclaw
Query!
Country [263]
0
0
Poland
Query!
State/province [263]
0
0
Zabrze
Query!
Country [264]
0
0
Portugal
Query!
State/province [264]
0
0
Coimbra
Query!
Country [265]
0
0
Portugal
Query!
State/province [265]
0
0
Lisboa
Query!
Country [266]
0
0
Portugal
Query!
State/province [266]
0
0
Porto
Query!
Country [267]
0
0
Portugal
Query!
State/province [267]
0
0
Vila Nova de Gaia
Query!
Country [268]
0
0
Russian Federation
Query!
State/province [268]
0
0
Moscow
Query!
Country [269]
0
0
Russian Federation
Query!
State/province [269]
0
0
St. Petersburg
Query!
Country [270]
0
0
Singapore
Query!
State/province [270]
0
0
Singapore
Query!
Country [271]
0
0
Slovakia
Query!
State/province [271]
0
0
Bratislava
Query!
Country [272]
0
0
Slovakia
Query!
State/province [272]
0
0
Martin
Query!
Country [273]
0
0
Slovakia
Query!
State/province [273]
0
0
Poprad
Query!
Country [274]
0
0
Slovakia
Query!
State/province [274]
0
0
Topolcany
Query!
Country [275]
0
0
Slovenia
Query!
State/province [275]
0
0
Golnik
Query!
Country [276]
0
0
Slovenia
Query!
State/province [276]
0
0
Kamnik
Query!
Country [277]
0
0
Slovenia
Query!
State/province [277]
0
0
Ljubljana
Query!
Country [278]
0
0
Slovenia
Query!
State/province [278]
0
0
Topolsica
Query!
Country [279]
0
0
South Africa
Query!
State/province [279]
0
0
Bloemfontein
Query!
Country [280]
0
0
South Africa
Query!
State/province [280]
0
0
Cape Town
Query!
Country [281]
0
0
South Africa
Query!
State/province [281]
0
0
Durban
Query!
Country [282]
0
0
South Africa
Query!
State/province [282]
0
0
George
Query!
Country [283]
0
0
South Africa
Query!
State/province [283]
0
0
Paarl
Query!
Country [284]
0
0
South Africa
Query!
State/province [284]
0
0
Pretoria
Query!
Country [285]
0
0
South Africa
Query!
State/province [285]
0
0
Somerset West
Query!
Country [286]
0
0
South Africa
Query!
State/province [286]
0
0
Vanderbijlpark
Query!
Country [287]
0
0
South Africa
Query!
State/province [287]
0
0
Welkom
Query!
Country [288]
0
0
Spain
Query!
State/province [288]
0
0
A Coruña
Query!
Country [289]
0
0
Spain
Query!
State/province [289]
0
0
Alicante
Query!
Country [290]
0
0
Spain
Query!
State/province [290]
0
0
Badajoz
Query!
Country [291]
0
0
Spain
Query!
State/province [291]
0
0
Badalona (Barcelona)
Query!
Country [292]
0
0
Spain
Query!
State/province [292]
0
0
Barakaldo (Bilbao)
Query!
Country [293]
0
0
Spain
Query!
State/province [293]
0
0
Barcelona
Query!
Country [294]
0
0
Spain
Query!
State/province [294]
0
0
Girona
Query!
Country [295]
0
0
Spain
Query!
State/province [295]
0
0
Guadalajara
Query!
Country [296]
0
0
Spain
Query!
State/province [296]
0
0
Huesca
Query!
Country [297]
0
0
Spain
Query!
State/province [297]
0
0
Jerez de la Frontera
Query!
Country [298]
0
0
Spain
Query!
State/province [298]
0
0
Leganés, Madrid
Query!
Country [299]
0
0
Spain
Query!
State/province [299]
0
0
Madrid
Query!
Country [300]
0
0
Spain
Query!
State/province [300]
0
0
Málaga
Query!
Country [301]
0
0
Spain
Query!
State/province [301]
0
0
Palma de Mallorca
Query!
Country [302]
0
0
Spain
Query!
State/province [302]
0
0
Pontevedra
Query!
Country [303]
0
0
Spain
Query!
State/province [303]
0
0
Reus (Tarragona)
Query!
Country [304]
0
0
Spain
Query!
State/province [304]
0
0
Sabadell (Barcelona)
Query!
Country [305]
0
0
Spain
Query!
State/province [305]
0
0
Santa Cruz de Tenerife
Query!
Country [306]
0
0
Spain
Query!
State/province [306]
0
0
Santander
Query!
Country [307]
0
0
Spain
Query!
State/province [307]
0
0
Sevilla
Query!
Country [308]
0
0
Spain
Query!
State/province [308]
0
0
Terrassa (Barcelona)
Query!
Country [309]
0
0
Spain
Query!
State/province [309]
0
0
Valencia
Query!
Country [310]
0
0
Spain
Query!
State/province [310]
0
0
Vigo
Query!
Country [311]
0
0
Spain
Query!
State/province [311]
0
0
Zaragoza
Query!
Country [312]
0
0
Switzerland
Query!
State/province [312]
0
0
Basel
Query!
Country [313]
0
0
Switzerland
Query!
State/province [313]
0
0
Faltigberg
Query!
Country [314]
0
0
Switzerland
Query!
State/province [314]
0
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Thailand
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Sheffield
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Solihull, Birmingham
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Funding & Sponsors
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Boehringer Ingelheim
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Summary
Brief summary
The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.
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Trial website
https://clinicaltrials.gov/study/NCT00144339
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Trial related presentations / publications
Rabe KF, Halpin DMG, Han MK, Miravitlles M, Singh D, Gronke L, Voss F, Martinez FJ. Composite endpoints in COPD: clinically important deterioration in the UPLIFT trial. Respir Res. 2020 Jul 9;21(1):177. doi: 10.1186/s12931-020-01431-y. Tashkin DP, Miravitlles M, Celli BR, Metzdorf N, Mueller A, Halpin DMG, Anzueto A. Concomitant inhaled corticosteroid use and the risk of pneumonia in COPD: a matched-subgroup post hoc analysis of the UPLIFT(R) trial. Respir Res. 2018 Oct 5;19(1):196. doi: 10.1186/s12931-018-0874-0. Celli BR, Decramer M, Liu D, Metzdorf N, Asijee GM, Tashkin DP. Defining a COPD composite safety endpoint for demonstrating efficacy in clinical trials: results from the randomized, placebo-controlled UPLIFT(R) trial. Respir Res. 2016 May 4;17(1):48. doi: 10.1186/s12931-016-0361-4. Goossens LM, Leimer I, Metzdorf N, Becker K, Rutten-van Molken MP. Does the 2013 GOLD classification improve the ability to predict lung function decline, exacerbations and mortality: a post-hoc analysis of the 4-year UPLIFT trial. BMC Pulm Med. 2014 Oct 18;14:163. doi: 10.1186/1471-2466-14-163. Tashkin DP, Li N, Kleerup EC, Halpin D, Celli B, Decramer M, Elashoff R. Acute bronchodilator responses decline progressively over 4 years in patients with moderate to very severe COPD. Respir Res. 2014 Aug 31;15(1):102. doi: 10.1186/s12931-014-0102-5. Janssens W, Liu Y, Liu D, Kesten S, Tashkin DP, Celli BR, Decramer M. Quality and reproducibility of spirometry in COPD patients in a randomized trial (UPLIFT(R)). Respir Med. 2013 Sep;107(9):1409-16. doi: 10.1016/j.rmed.2013.04.015. Epub 2013 May 25. Tashkin DP, Celli BR, Decramer M, Lystig T, Liu D, Kesten S. Efficacy of tiotropium in COPD patients with FEV1 >/= 60% participating in the UPLIFT(R) trial. COPD. 2012 Jun;9(3):289-96. doi: 10.3109/15412555.2012.656211. Epub 2012 Mar 20. Kesten S, Celli B, Decramer M, Liu D, Tashkin D. Adverse health consequences in COPD patients with rapid decline in FEV1--evidence from the UPLIFT trial. Respir Res. 2011 Sep 28;12(1):129. doi: 10.1186/1465-9921-12-129. Tashkin D, Celli B, Kesten S, Lystig T, Decramer M. Effect of tiotropium in men and women with COPD: results of the 4-year UPLIFT trial. Respir Med. 2010 Oct;104(10):1495-504. doi: 10.1016/j.rmed.2010.03.033. Epub 2010 Apr 24. Troosters T, Celli B, Lystig T, Kesten S, Mehra S, Tashkin DP, Decramer M; Uplift Investigators. Tiotropium as a first maintenance drug in COPD: secondary analysis of the UPLIFT trial. Eur Respir J. 2010 Jul;36(1):65-73. doi: 10.1183/09031936.00127809. Epub 2010 Feb 25. Decramer M, Celli B, Kesten S, Lystig T, Mehra S, Tashkin DP; UPLIFT investigators. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial. Lancet. 2009 Oct 3;374(9696):1171-8. doi: 10.1016/S0140-6736(09)61298-8. Epub 2009 Aug 27. Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, Decramer M; UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008 Oct 9;359(15):1543-54. doi: 10.1056/NEJMoa0805800. Epub 2008 Oct 5.
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Public notes
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Contacts
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Boehringer Ingelheim
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Boehringer Ingelheim
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00144339
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