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Phase 3 N=151 Randomized Double-blind Treatment

Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry I

Pulmonary Disease, Chronic Obstructive

Enrolled (actual)
151
Serious AEs
2.1%
Results posted
Jul 2014
Primary outcome: Primary: Adjusted Mean Endurance Time After 6 Weeks — 369.81; 421.58; 420.72 seconds — p=0.0002

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Olodaterol (BI 1744) (Drug); Placebo (Drug); Olodaterol (BI 1744) Placebo (Drug)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Boehringer Ingelheim
Primary completion
Apr 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Adjusted Mean Endurance Time After 6 Weeks
369.81; 421.58; 420.72 0.0002 sig
SECONDARY
Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks
1.917; 2.099; 2.091 <0.0001 sig
SECONDARY
Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks
5.870; 5.104; 5.235 0.0007 sig
SECONDARY
Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks
2.220; 2.478; 2.513 <0.0001 sig
SECONDARY
Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks
1.887; 2.067; 2.024 <0.0001 sig
SECONDARY
Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks
0.288; 0.185; 0.224 0.0447 sig
SECONDARY
Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks
6.978; 6.890; 7.234 0.5698
SECONDARY
Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks
4.977; 4.855; 4.862 0.0784
SECONDARY
Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks
4.950; 4.740; 4.577 0.0015 sig
SECONDARY
Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks
2.170; 2.289; 2.262 0.0005 sig
SECONDARY
Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks
2.221; 2.427; 2.437 <0.0001 sig
SECONDARY
Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks
7.142; 7.148; 7.121 0.9239
SECONDARY
Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks
7.156; 7.142; 6.997 0.8302
SECONDARY
Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks
1.475; 1.564; 1.576 <0.0001 sig
SECONDARY
Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks
1.473; 1.698; 1.699 <0.0001 sig
SECONDARY
Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks
3.212; 3.319; 3.310 0.0006 sig
SECONDARY
Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks
3.187; 3.471; 3.477 <0.0001 sig
SECONDARY
Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks
4.374; 4.692; 4.677 <0.0001 sig
SECONDARY
Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks
4.363; 4.949; 4.981 <0.0001 sig
SECONDARY
Change From Baseline to Day 43 in Blood Pressure
-3.5; -2.7; -3.3; -1.7; -1.8; -1.1
SECONDARY
Change From Baseline to Day 43 in Pulse Rate
-5.1; -5.1; -3
SECONDARY
Number of Patients With Notable Changes in Heart Rate
0.7; 0.7; 0.7; 1.4; 2.9; 2.1
SECONDARY
Number of Patients With Notable Increase in PR Intervals
0.0; 0.7; 0.0; 100.0; 99.3; 100.0
SECONDARY
Number of Patients With Notable Increase in QRS Intervals
0.7; 0.7; 0.0; 99.3; 99.3; 100.0

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

  • Signed informed consent prior to participation.
  • Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec) x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN.
  • Patients with a history of asthma and/or total blood eosinophil count of 600 cells/mm3.
  • Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute).
  • 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.
  • Patients who have undergone thoracotomy with pulmonary resection.
  • 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.
  • Patients who regularly use daytime oxygen for more than one hour per day.
  • 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.
  • Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea.
  • Pregnant or nursing women.
  • Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01040130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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