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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01040130
Registration number
NCT01040130
Ethics application status
Date submitted
28/12/2009
Date registered
29/12/2009
Date last updated
8/07/2014
Titles & IDs
Public title
Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry I
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Scientific title
Randomised, Double-blind, Placebo-controlled, 3-way Cross-over Study to Determine the Effect of Treatment of Orally Inhaled BI 1744 CL (5 µg [2 Actuations of 2.5 µg] and 10 µg [2 Actuations of 5 µg]) Delivered by the Respimat® Inhaler on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease
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Secondary ID [1]
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2009-014395-21
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Secondary ID [2]
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1222.37
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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
Treatment: Drugs - Olodaterol (BI 1744)
Treatment: Drugs - Olodaterol (BI 1744)
Treatment: Drugs - Placebo
Treatment: Drugs - Olodaterol (BI 1744)
Treatment: Drugs - Olodaterol (BI 1744) Placebo
Experimental: Olodaterol (BI 1744) Low - Low dose inhaled orally once daily from the Respimat inhaler
Experimental: Olodaterol (BI 1744) High - High dose inhaled orally once daily from the Respimat inhaler
Placebo Comparator: Placebo - Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler
Treatment: Drugs: Olodaterol (BI 1744)
Comparison of low and high doses on exercise endurance time in COPD patients
Treatment: Drugs: Olodaterol (BI 1744)
Comparison of low and high doses on exercise endurance time in COPD patients
Treatment: Drugs: Placebo
Comparison of low and high dose and placebo on exercise endurance time in COPD patients
Treatment: Drugs: Olodaterol (BI 1744)
Comparison of low and high dose
Treatment: Drugs: Olodaterol (BI 1744) Placebo
Placebo that represents olodaterol
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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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Adjusted Mean Endurance Time After 6 Weeks
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Assessment method [1]
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Primary endpoint was endurance time during constant work rate ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. Mixed effects model on log10 transformation data. Adjusted means are back transformed to report as geometric means. Standard errors (SEs) are calculated using the delta method.
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Timepoint [1]
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6 weeks
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Secondary outcome [1]
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Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks
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Assessment method [1]
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Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.
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Timepoint [1]
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6 weeks
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Secondary outcome [2]
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Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks
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Assessment method [2]
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Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.
Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.
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Timepoint [2]
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6 weeks
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Secondary outcome [3]
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Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks
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Assessment method [3]
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Timepoint [3]
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6 weeks
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Secondary outcome [4]
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Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks
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Assessment method [4]
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Timepoint [4]
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6 weeks
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Secondary outcome [5]
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Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks
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Assessment method [5]
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Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.
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Timepoint [5]
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6 weeks
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Secondary outcome [6]
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Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks
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Assessment method [6]
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Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.
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Timepoint [6]
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6 weeks
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Secondary outcome [7]
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Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks
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Assessment method [7]
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Timepoint [7]
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6 weeks
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Secondary outcome [8]
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Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks
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Assessment method [8]
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Timepoint [8]
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6 weeks
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Secondary outcome [9]
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Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks
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Assessment method [9]
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Measured using body plethysmography
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Timepoint [9]
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6 weeks
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Secondary outcome [10]
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Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks
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Assessment method [10]
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Measured using body plethysmography
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Timepoint [10]
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6 weeks
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Secondary outcome [11]
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Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks
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Assessment method [11]
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Measured using body plethysmography
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Timepoint [11]
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6 weeks
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Secondary outcome [12]
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Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks
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Assessment method [12]
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Timepoint [12]
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6 weeks
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Secondary outcome [13]
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Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks
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Assessment method [13]
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Timepoint [13]
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6 weeks
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Secondary outcome [14]
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Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks
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Assessment method [14]
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Timepoint [14]
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6 weeks
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Secondary outcome [15]
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Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks
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Assessment method [15]
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Timepoint [15]
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6 weeks
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Secondary outcome [16]
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Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks
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Assessment method [16]
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Timepoint [16]
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6 weeks
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Secondary outcome [17]
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Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks
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Assessment method [17]
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Timepoint [17]
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6 weeks
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Secondary outcome [18]
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Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks
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Assessment method [18]
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Timepoint [18]
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6 weeks
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Secondary outcome [19]
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Change From Baseline to Day 43 in Blood Pressure
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Assessment method [19]
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Change from Baseline to Day 43 in Blood Pressure with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.
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Timepoint [19]
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Baseline and Week 6
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Secondary outcome [20]
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Change From Baseline to Day 43 in Pulse Rate
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Assessment method [20]
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Change from Baseline to Day 43 in Pulse rate with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.
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Timepoint [20]
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Baseline and Week 6
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Secondary outcome [21]
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Number of Patients With Notable Changes in Heart Rate
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Assessment method [21]
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Number of Patients with notable changes in heart rate (HR). Notable HR increase defined as >=25% increase and on-treatment HR > 100 bpm; Notable HR decrease defined as >=25% decrease and on-treatment HR < 50 bpm.
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Timepoint [21]
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Baseline and Week 6
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Secondary outcome [22]
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Number of Patients With Notable Increase in PR Intervals
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Assessment method [22]
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Number of Patients with notable increase in PR intervals. Notable PR interval increase defined as >=25% increase and on-treatment PR interval > 200 ms.
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Timepoint [22]
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Baseline and Week 6
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Secondary outcome [23]
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Number of Patients With Notable Increase in QRS Intervals
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Assessment method [23]
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Number of Patients with notable increase in QRS intervals. Notable QRS interval increase defined as >=10% increase and on-treatment QRS interval > 110 ms.
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Timepoint [23]
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Baseline and Week 6
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. Signed informed consent prior to participation.
2. Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced
Expiratory Volume in 1 sec) <80% of predicted normal and post-bronchodilator
FEV1(Forced Expiratory Volume in 1 sec)/FVC of < 70% at Visit 1.
3. Male or female between 40 and 75 years of age.
4. Current or ex-smokers with smoking history of more than 10-pack years.
5. Able to perform technically acceptable pulmonary function tests, multiple exercise
tests and able to maintain records.
6. Able to inhale medication in a competent manner from a metered-dose inhaler and
Respimat inhaler.
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Minimum age
40
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Maximum age
75
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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
Exclusion criteria:
1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or
urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or
creatinine >x2 ULN.
2. Patients with a history of asthma and/or total blood eosinophil count of 600
cells/mm3.
3. Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute).
4. Patients with a history of myocardial infarction within 1 year of screening visit,
unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure
within the past year, known active tuberculosis, a malignancy for which patient has
undergone resection, radiation therapy or chemotherapy within last five years,
life-threatening pulmonary obstruction, cystic fibrosis, clinically evident
bronchiectasis, significant alcohol or drug abuse or contraindications to exercise.
5. Patients who have undergone thoracotomy with pulmonary resection.
6. Patients being treated with oral beta-adrenergics or oral corticosteroid medication at
unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of
the equivalent of 10 mg of prednisone per day or 20 mg every other day.
7. Patients who regularly use daytime oxygen for more than one hour per day.
8. Patients who have completed a pulmonary rehabilitation program in the six weeks prior
to the screening visit or patients who are currently in a pulmonary rehabilitation
program.
9. Patients who have a limitation of exercise performance as a result of factors other
than fatigue or exertional dyspnea.
10. Pregnant or nursing women.
11. Women of childbearing potential not using two effective methods of birth control (one
barrier and one non-barrier).
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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?
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Intervention assignment
Crossover
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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
1/01/2010
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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
151
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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1222.37.6171 Boehringer Ingelheim Investigational Site - Daw Park
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Recruitment hospital [2]
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1222.37.6174 Boehringer Ingelheim Investigational Site - Clayton
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Recruitment hospital [3]
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1222.37.6173 Boehringer Ingelheim Investigational Site - Heidelberg
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Recruitment hospital [4]
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1222.37.6172 Boehringer Ingelheim Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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- Daw Park
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Recruitment postcode(s) [2]
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- Clayton
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Recruitment postcode(s) [3]
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- Heidelberg
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Recruitment postcode(s) [4]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Gänserndorf
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Country [2]
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Austria
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State/province [2]
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Neumarkt am Wallersee
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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Canada
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State/province [4]
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Quebec
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Country [5]
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France
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State/province [5]
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Bethune Cedex
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Country [6]
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France
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State/province [6]
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Montpellier
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Country [7]
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France
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State/province [7]
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Nîmes
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Country [8]
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France
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State/province [8]
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Paris
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Country [9]
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France
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State/province [9]
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Perpignan
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Country [10]
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France
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State/province [10]
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Strasbourg
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Country [11]
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Germany
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State/province [11]
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Berlin
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Country [12]
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Germany
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State/province [12]
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Halle
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Country [13]
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Germany
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State/province [13]
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Magdeburg
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Country [14]
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Germany
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State/province [14]
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Rüdersdorf
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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
To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of
treatment in patients with Chronic Obstructive Pulmonary Disease
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01040130
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Boehringer Ingelheim
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Address
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Boehringer Ingelheim
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01040130
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