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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01005901
Registration number
NCT01005901
Ethics application status
Date submitted
30/10/2009
Date registered
1/11/2009
Date last updated
12/04/2012
Titles & IDs
Public title
A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo
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Scientific title
A 26-week Treatment, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
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Secondary ID [1]
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2009-013504-32
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Secondary ID [2]
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CNVA237A2304
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Universal Trial Number (UTN)
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Trial acronym
GLOW 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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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
Treatment: Drugs - Glycopyrronium bromide
Treatment: Drugs - Placebo
Experimental: Glycopyrronium bromide - Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At visit 1 all patients were provided with a short acting ß2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
Placebo comparator: Placebo - Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting ß2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
Treatment: Drugs: Glycopyrronium bromide
Glycopyrronium bromide 50µg was supplied as inhalation capsules for use via a Single Dose Dry Powder Inhaler (SDDPI)
Treatment: Drugs: Placebo
Placebo inhalation capsules were provided for use via a SDDPI
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Intervention code [1]
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Treatment: Drugs
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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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Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks
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Assessment method [1]
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Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
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Timepoint [1]
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12 weeks
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Secondary outcome [1]
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Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment
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Assessment method [1]
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Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline. Mixed model used baseline TDI, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
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Timepoint [1]
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26 weeks
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Secondary outcome [2]
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Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 26 Weeks of Treatment
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Assessment method [2]
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SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Mixed model used baseline SGRQ, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
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Timepoint [2]
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26 weeks
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Secondary outcome [3]
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Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During 26 Weeks of Treatment
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Assessment method [3]
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The time to the first moderate or severe COPD exacerbation was the study day on which the patient experienced first moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if treatment for moderate severity and hospitalization were required.
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Timepoint [3]
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26 weeks
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Secondary outcome [4]
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Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (Baseline to Week 26)
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Assessment method [4]
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Participants recorded the number of puffs of rescue medication taken in the previous 12 hours in the morning and evening. The total number of puffs of rescue medication per day over the full 26 weeks was calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the patient.
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Timepoint [4]
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26 weeks
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Secondary outcome [5]
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FEV1 at Each Time-point on Day 1 and Week 26
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Assessment method [5]
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Spirometry was conducted according to internationally accepted standards. FEV1 was measured at all time points up to 4 hours post-dose, and at 23 hours 15 min and 23 hours 45 min, by visit. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
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Timepoint [5]
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Day 1 and Week 26
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Secondary outcome [6]
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Forced Vital Capacity (FVC) at Each Time-point on Day 1 and Week 26
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Assessment method [6]
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Spirometry was conducted according to internationally accepted standards. FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 min and 23 hours 45 min, by visit. Mixed model used baseline FVC, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
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Timepoint [6]
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Day 1 and Week 26
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Secondary outcome [7]
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FEV1 Area Under the Curve (AUC) (5 Min - 12 Hour) at Day 1, Week 12 and Week 26
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Assessment method [7]
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The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post dose at Week 1 Day 1, Week 12 and Week 26 for every patient in the serial spirometry subgroup. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
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Timepoint [7]
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Day 1, Week 12 and Week 26
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Secondary outcome [8]
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FEV1 Area Under Curve (AUC) (5 Min - 23 Hour 45 Min) at Week 12 and Week 26
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Assessment method [8]
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The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 23 h 45 min post dose at week12/week 13and week 26/week 27 where available for every patient in the serial spirometry subgroup. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
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Timepoint [8]
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Week 12 and Week 26
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Secondary outcome [9]
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Trough FEV1 and FVC at Day 1 and Week 26
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Assessment method [9]
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Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.
Trough FVC was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FVC readings. Mixed model used baseline FVC, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.
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Timepoint [9]
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Day 1 and Week 26
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Secondary outcome [10]
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Change in 24-hourly Mean Heart Rate at Day 1, Week 12 and Week 26
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Assessment method [10]
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The mean heart rate was collected with a 24 hour Holter monitor in a sub-set of the safety population. The change between baseline and day 1, week 12 and week 26 was calculated. The analysis of the Holter recordings was performed by a central facility. Data on heart rate, heart rate variability, supraventricular and ventricular ectopy were collected and assessed.
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Timepoint [10]
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Baseline, Day 1, Week 12 and Week 26
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Secondary outcome [11]
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Number of Participants With Adverse Events, Death, and Serious or Clinically Significant Adverse Events or Related Discontinuations
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Assessment method [11]
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Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
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Timepoint [11]
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26 Weeks and 30 Day follow-up
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Secondary outcome [12]
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Rate of Moderate or Severe COPD Exacerbations Over the 26 Week Treatment Period
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Assessment method [12]
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One overall rate is calculated for the entire study population. Rate is the number of moderate or severe exacerbations per year = total number of moderate or severe exacerbations for all participants/total number of treatment years for all participants. COPD exacerbations were considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations were considered to be severe if treatment for moderate severity and hospitalization were required.
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Timepoint [12]
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26 weeks
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Secondary outcome [13]
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Percentage of Nights With no Nighttime Awakenings Over the 26 Week Treatment Period
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Assessment method [13]
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The percentage of nights with no nighttime awakenings is defined as the total number of nights with no nighttime awakenings over the 26 week treatment period divided by the total number of night where diary recordings have been made.
Mixed model used baseline nighttime awakenings, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.
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Timepoint [13]
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26 Weeks
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Secondary outcome [14]
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Percentage of Days With no Daytime Symptoms Over the 26 Week Treatment Period
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Assessment method [14]
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The percentage of days with no daytime symptoms is defined as the total number of days with no daytime symptoms over the 26 week treatment period divided by the total number of days where diary recordings have been made.
Mixed model used baseline daytime symptoms, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.
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Timepoint [14]
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26 Weeks
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Secondary outcome [15]
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Percentage of Days Able to Perform Usual Daily Activities Over the 26 Week Treatment Period
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Assessment method [15]
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The percentage of days able to perform usual daily activities is defined as the total number of days able to perform usual activities over the 26 week treatment period divided by the total number of days where diary recordings have been made.
Mixed model used baseline ability to perform usual daily activities, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.
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Timepoint [15]
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26 Weeks
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Secondary outcome [16]
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Mean Daily Total Symptom Score Over the 26 Week Treatment Period
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Assessment method [16]
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The daily symptom score was calculated as the sum of the worst of the morning and evening assessments for each symptom (symptoms, cough, wheeze, sputum color/production, and breathlessness). The score can range from 0 to 18 with 0 indicating no symptoms. The higher the score, the worse the symptomatic status. A negative change (lower number) indicates improvement.
Mixed model used baseline symptom variables, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
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Timepoint [16]
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26 Weeks
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Eligibility
Key inclusion criteria
1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:
* Smoking history of at least 10 pack-years
* Post-bronchodilator FEV1 < 80% and = 30% of the predicted normal value
* Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
2. Patients with concomitant pulmonary disease
3. Patients with a history of asthma
4. Any patient with lung cancer or a history of lung cancer
5. Patients with a history of certain cardiovascular comorbid conditions
6. Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
7. Patients in the active phase of a supervised pulmonary rehabilitation program
8. Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents Other protocol-defined inclusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2010
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Sample size
Target
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Accrual to date
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Final
1324
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Novartis Investigative Site - Daw Park SA
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Recruitment postcode(s) [1]
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- Daw Park SA
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Delaware
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Florida
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Kansas
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Kentucky
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United States of America
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Louisiana
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Maine
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United States of America
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Maryland
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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Nevada
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New Jersey
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New York
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Ohio
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Oklahoma
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Rhode Island
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Tennessee
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Texas
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Virginia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Japan
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Asahikawa
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Japan
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Hamakita
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Japan
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Himeji
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Japan
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Hitachi
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Japan
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Kishiwada
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Japan
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Kyoto
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Japan
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Matsue
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Japan
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Matsusaka
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Moriya
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Japan
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Naka-gun
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Obihiro
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Osaka
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Ota
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Otsu
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Sapporo
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Takatsuki
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Japan
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Tokyo
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Yabu
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Japan
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Yonezawa
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Korea, Republic of
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Daegu
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Pusan
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Seoul
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Netherlands
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Almelo
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Netherlands
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Eindhoven
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Netherlands
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Harderwijk
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Heerlen
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Netherlands
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Zutphen
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Iasi
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Romania
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Timisoara
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Russian Federation
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Irkutsk
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Russian Federation
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Kazan
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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N. Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Sochy
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Russian Federation
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Stavropol
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Russian Federation
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Yaroslavl
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0
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Singapore
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Singapore
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Spain
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Alicante
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Spain
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Badalona
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Spain
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Caceres
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Spain
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Canet de Mar
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Spain
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Centelles
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Spain
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Valencia
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Turkey
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Altunizade
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Turkey
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Aydin
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Turkey
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Diyarbakir
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kinikli/Denizli
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Turkey
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Mersin
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Turkey
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Soke/Aydin
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Turkey
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Yenisehir/Izmir
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis
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Ethics approval
Ethics application status
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Summary
Brief summary
A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
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Trial website
https://clinicaltrials.gov/study/NCT01005901
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Trial related presentations / publications
D'Urzo A, Ferguson GT, van Noord JA, Hirata K, Martin C, Horton R, Lu Y, Banerji D, Overend T. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res. 2011 Dec 7;12(1):156. doi: 10.1186/1465-9921-12-156. D'Urzo A, Kerwin E, Overend T, D'Andrea P, Chen H, Goyal P. Once daily glycopyrronium for the treatment of COPD: pooled analysis of the GLOW1 and GLOW2 studies. Curr Med Res Opin. 2014 Mar;30(3):493-508. doi: 10.1185/03007995.2013.858618. Epub 2013 Nov 19.
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for public queries
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Contact person for scientific queries
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
Type
Citations or Other Details
Journal
D'Urzo A, Ferguson GT, van Noord JA, Hirata K, Mar...
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More Details
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Results are available at
https://clinicaltrials.gov/study/NCT01005901
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