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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00387088
Registration number
NCT00387088
Ethics application status
Date submitted
11/10/2006
Date registered
12/10/2006
Date last updated
16/05/2014
Titles & IDs
Public title
Tiotropium / Respimat One Year Study in COPD.
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Scientific title
Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD
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Secondary ID [1]
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2006-001009-27
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Secondary ID [2]
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205.372
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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
Other: Tiotropium - Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Other: Placebo - Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
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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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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337
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Assessment method [1]
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Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).
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Timepoint [1]
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Baseline and Day 337
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Primary outcome [2]
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Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
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Assessment method [2]
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Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.
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Timepoint [2]
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During actual study treatment period (planned Day 1 to Day 337)
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Secondary outcome [1]
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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
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Assessment method [1]
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Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
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Timepoint [1]
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Baseline and Day 29
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Secondary outcome [2]
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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169
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Assessment method [2]
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Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
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Timepoint [2]
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Baseline and Day 169
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Secondary outcome [3]
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Number of COPD Exacerbations Per Patient - Exposure Adjusted
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Assessment method [3]
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Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
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Timepoint [3]
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During actual study treatment period (planned Day 1 to Day 337)
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Secondary outcome [4]
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Number of COPD Exacerbations Per Patient - naïve Estimate
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Assessment method [4]
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Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
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Timepoint [4]
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During actual study treatment period (planned Day 1 to Day 337)
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Secondary outcome [5]
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Number of Patients With at Least One COPD Exacerbation
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Assessment method [5]
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Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
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Timepoint [5]
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During actual study treatment period (planned Day 1 to Day 337)
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Secondary outcome [6]
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Time to First Hospitalisation for COPD Exacerbation
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Assessment method [6]
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Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation
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Timepoint [6]
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During actual study treatment period (planned Day 1 to Day 337)
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Secondary outcome [7]
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Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted
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Assessment method [7]
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Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
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Timepoint [7]
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During actual study treatment period (planned Day 1 to Day 337)
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Secondary outcome [8]
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Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate
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Assessment method [8]
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Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
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Timepoint [8]
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During actual study treatment period (planned Day 1 to Day 337)
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Secondary outcome [9]
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Number of Patients With at Least One Hospitalisation for a COPD Exacerbation
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Assessment method [9]
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Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
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Timepoint [9]
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During actual study treatment period (planned Day 1 to Day 337)
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Secondary outcome [10]
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Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337
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Assessment method [10]
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The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
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Timepoint [10]
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Baseline and Day 337
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Secondary outcome [11]
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Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169
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Assessment method [11]
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The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
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Timepoint [11]
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Baseline and Day 169
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Secondary outcome [12]
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Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337
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Assessment method [12]
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The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
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Timepoint [12]
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Baseline and Day 337
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Secondary outcome [13]
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Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169
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Assessment method [13]
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The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
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Timepoint [13]
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Baseline and Day 169
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Secondary outcome [14]
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Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29
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Assessment method [14]
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Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
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Timepoint [14]
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Baseline and Day 29
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Secondary outcome [15]
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Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169
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Assessment method [15]
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Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
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Timepoint [15]
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Baseline and Day 169
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Secondary outcome [16]
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Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337
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Assessment method [16]
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Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
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Timepoint [16]
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Baseline and Day 337
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Secondary outcome [17]
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Marked Changes From Baseline in Vital Signs at End of Treatment
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Assessment method [17]
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Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.
SBP - Increase means SBP \>150 mmHg and an increase above baseline of \>25 mmHg. SBP - Decrease means SBP \<100 mmHg and a decrease below baseline of \>10 mmHg.
DBP - Increase means DBP \>90 mmHg and an increase above baseline of \>10 mmHg. DBP - Decrease means DBP \<60 mmHg and a decrease below baseline of \>10 mmHg.
PR - Increase means PR \>100 bpm and an increase above baseline of \>10 bpm. PR - Decrease means PR \<60 bpm and a decrease below baseline of \>10 bpm.
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Timepoint [17]
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Baseline and end of treatment
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Secondary outcome [18]
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Clinically Relevant Findings in Physical Examination and ECG
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Assessment method [18]
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Clinically relevant findings in Physical Examination and ECG at end of treatment
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Timepoint [18]
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End of treatment
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Eligibility
Key inclusion criteria
1. Male or female
2. At least 40 years old
3. Smoker or ex-smoker
4. Smoking history > 10 pack-years
5. Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted
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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. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
2. History of asthma or allergic conditions.
3. Malignancy requiring treatment within past 5 years
4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
5. Known active tuberculosis
6. Known hypersensitivity to anticholinergic drugs.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
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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?
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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
1/09/2006
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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
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Sample size
Target
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Accrual to date
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Final
3991
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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205.372.61002 Woolcock Institute of Medical Research - Glebe
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Recruitment hospital [2]
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205.372.61009 Thoracic & General Physician - Cairns
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Recruitment hospital [3]
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205.372.61005 Redcliffe Hospital - Redcliffe
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Recruitment hospital [4]
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205.372.61006 The Investigator Clinic - Port Lincoln
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Recruitment hospital [5]
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205.372.61007 The Burnside War Memorial Hospital - Toorak Gardens
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Recruitment hospital [6]
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205.372.61004 Boehringer Ingelheim Investigational Site - Woodville
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Recruitment hospital [7]
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205.372.61010 Ecru - Box Hill
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Recruitment hospital [8]
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205.372.61008 Geelong Clinical Research Centre - Geelong
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Recruitment hospital [9]
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205.372.61001 Emeritus Research - Malvern
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Recruitment hospital [10]
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205.372.61003 Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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- Glebe
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Recruitment postcode(s) [2]
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- Cairns
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Recruitment postcode(s) [3]
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- Redcliffe
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Recruitment postcode(s) [4]
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- Port Lincoln
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Recruitment postcode(s) [5]
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- Toorak Gardens
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Recruitment postcode(s) [6]
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- Woodville
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Recruitment postcode(s) [7]
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- Box Hill
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Recruitment postcode(s) [8]
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- Geelong
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Recruitment postcode(s) [9]
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- Malvern
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Recruitment postcode(s) [10]
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- Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Colorado
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Country [4]
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United States of America
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State/province [4]
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Connecticut
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Country [5]
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United States of America
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State/province [5]
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Florida
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Country [6]
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United States of America
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State/province [6]
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Georgia
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Country [7]
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United States of America
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State/province [7]
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Illinois
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Country [8]
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United States of America
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State/province [8]
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Iowa
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Country [9]
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United States of America
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State/province [9]
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Kansas
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Country [10]
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United States of America
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State/province [10]
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Louisiana
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Country [11]
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United States of America
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State/province [11]
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Maine
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Country [12]
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United States of America
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State/province [12]
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Maryland
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Country [13]
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United States of America
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State/province [13]
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Michigan
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Country [14]
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United States of America
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State/province [14]
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Minnesota
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Country [15]
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United States of America
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State/province [15]
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Missouri
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Country [16]
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United States of America
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State/province [16]
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Nebraska
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United States of America
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New Mexico
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United States of America
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New York
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Country [19]
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United States of America
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State/province [19]
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North Carolina
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United States of America
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Ohio
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Country [21]
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United States of America
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Oklahoma
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Texas
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Country [25]
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United States of America
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Virginia
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Country [26]
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United States of America
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State/province [26]
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Washington
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Country [27]
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Brazil
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State/province [27]
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Florianópolis
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Country [28]
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Brazil
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State/province [28]
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Goiânia
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Country [29]
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Brazil
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State/province [29]
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Recife
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Country [30]
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Brazil
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State/province [30]
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São Paulo - SP
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Country [31]
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Brazil
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State/province [31]
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Vitória
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Country [32]
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Canada
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State/province [32]
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Alberta
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Country [33]
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Canada
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State/province [33]
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British Columbia
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Country [34]
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Canada
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New Brunswick
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Country [35]
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Canada
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State/province [35]
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Newfoundland and Labrador
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Country [36]
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Canada
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State/province [36]
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Ontario
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Country [37]
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Canada
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Quebec
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Country [38]
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Canada
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Saskatchewan
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Country [39]
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China
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Beijing
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China
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State/province [40]
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Chengdu, Sichuan Province
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Country [41]
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China
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Chongqing
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China
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Guangzhou
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China
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Shanghai
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China
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Shenyang
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China
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Wuhan
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Denmark
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Aarhus C
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Denmark
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Horsens
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Denmark
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Hvidovre
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Denmark
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State/province [49]
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København NV
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Denmark
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Odense C
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Denmark
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Silkeborg
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Finland
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Helsinki
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Finland
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Jyväskylä
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Finland
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Lahti
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Finland
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Tampere
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France
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Castelnau le Lez
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France
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Chamalières
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France
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Clermont Ferrand cedex 1
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France
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Denain
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France
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Grasse
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France
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Marseille
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France
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Metz cedex 1
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France
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Montigny les Metz
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France
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Nantes
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France
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Nice
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France
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Nimes cedex 9
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France
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Nîmes
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France
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Ollioules
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France
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Reims
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France
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Saint Laurent du Var
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France
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Six Four les Plages
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France
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St Gaudens
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France
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Toulon
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France
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Toulouse
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Bruchsal
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Germany
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Frankfurt/Main
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Germany
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Gelnhausen
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Germany
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Gütersloh
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Germany
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Hannover
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Germany
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Kassel
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Germany
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Minden
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Germany
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München
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Country [85]
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Germany
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Serres
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Porto
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Samsun
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Mortimer
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Nottingham
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Sheffield
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Windsor
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United Kingdom
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Woking
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.
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Trial website
https://clinicaltrials.gov/study/NCT00387088
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Trial related presentations / publications
Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1. Bateman ED, Tashkin D, Siafakas N, Dahl R, Towse L, Massey D, Pavia D, Zhong NS. A one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med. 2010 Oct;104(10):1460-72. doi: 10.1016/j.rmed.2010.06.004.
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Public notes
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Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
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Address
0
0
Boehringer Ingelheim
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0
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0
0
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Fax
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0
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Email
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0
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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
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00387088
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