Clinical trial NCT01040793: Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry II
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-12-30
Enrollment: 157
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

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).

Primary outcomes:
measure: Adjusted Mean Endurance Time After 6 Weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks
timeFrame: 6 weeks
measure: Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks
timeFrame: 6 weeks
measure: Change From Baseline to Day 43 in Blood Pressure
timeFrame: Baseline and Week 6
measure: Change From Baseline to Day 43 in Pulse Rate
timeFrame: Baseline and Week 6
measure: Number of Patients With Notable Changes in Heart Rate
timeFrame: Baseline and Week 6
measure: Number of Patients With Notable Increase in PR Intervals
timeFrame: Baseline and Week 6
measure: Number of Patients With Notable Increase in QRS Intervals
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Hallein
country: Austria
facility: 1222.38.4380 Boehringer Ingelheim Investigational Site
city: Leoben
country: Austria
facility: 1222.38.4381 Boehringer Ingelheim Investigational Site
city: Brussel
country: Belgium
facility: 1222.38.32004 Boehringer Ingelheim Investigational Site
city: Edegem
country: Belgium
facility: 1222.38.32002 Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: 1222.38.32001 Boehringer Ingelheim Investigational Site
city: Liège
country: Belgium
facility: 1222.38.32003 Boehringer Ingelheim Investigational Site
city: Vancouver
country: Canada
facility: 1222.38.1082 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Hamilton
country: Canada
facility: 1222.38.1081 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1222.38.1083 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 1222.38.1080 Boehringer Ingelheim Investigational Site
state: Quebec
city: Berlin
country: Germany
facility: 1222.38.4980 Boehringer Ingelheim Investigational Site
city: Dortmund
country: Germany
facility: 1222.38.4983 Boehringer Ingelheim Investigational Site
city: Großhansdorf
country: Germany
facility: 1222.38.4984 Boehringer Ingelheim Investigational Site
city: Kiel
country: Germany
facility: 1222.38.4981 Boehringer Ingelheim Investigational Site
city: Koblenz
country: Germany
facility: 1222.38.4986 Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: 1222.38.4985 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1222.38.7080 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1222.38.7081 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1222.38.7082 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Maltais F, Kirsten AM, Hamilton A, De Sousa D, Voss F, Decramer M. Evaluation of the effects of olodaterol on exercise endurance in patients with chronic obstructive pulmonary disease: results from two 6-week crossover studies. Respir Res. 2016 Jul 6;17(1):77. doi: 10.1186/s12931-016-0389-5.