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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01040793
First received: December 29, 2009
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Olodaterol (BI 1744)
Drug: Placebo
Drug: Olodaterol (BI1744)
Drug: Olodaterol (BI 1744) placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Adjusted Mean Endurance Time After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    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.


  • Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measured using body plethysmography

  • Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measured using body plethysmography

  • Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measured using body plethysmography

  • Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measured using body plethysmography

  • Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measured using body plethysmography

  • Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to Day 43 in Blood Pressure [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to Day 43 in Pulse Rate [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.

  • Number of Patients With Notable Changes in Heart Rate [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.

  • Number of Patients With Notable Increase in PR Intervals [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Number of Patients with notable increase in PR intervals. Notable PR interval increase defined as >=25% increase and on-treatment PR interval > 200 ms.

  • Number of Patients With Notable Increase in QRS Intervals [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Number of Patients with notable increase in QRS intervals. Notable QRS interval increase defined as >=10% increase and on-treatment QRS interval > 110 ms.


Enrollment: 157
Study Start Date: January 2010
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olodaterol (BI 1744) Low
Low dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744)
Comparison of low and high dose on exercise endurance time in COPD patients
Drug: Olodaterol (BI1744)
Comparison of low and high dose on exercise endurance time in COPD patients
Drug: Olodaterol (BI 1744) placebo
Placebo that represents olodaterol
Experimental: Olodaterol (BI 1744) High
High dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744)
Comparison of low and high dose on exercise endurance time in COPD patients
Placebo Comparator: Placebo
Olodaterol (BI 1744) placebo inhaled orally from the Respimat inhaler
Drug: Placebo
Comparison of low and high dose and placebo on exercise endurance time in COPD patients

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040793

Locations
Austria
1222.38.4380 Boehringer Ingelheim Investigational Site
Hallein, Austria
1222.38.4381 Boehringer Ingelheim Investigational Site
Leoben, Austria
Belgium
1222.38.32004 Boehringer Ingelheim Investigational Site
Brussel, Belgium
1222.38.32002 Boehringer Ingelheim Investigational Site
Edegem, Belgium
1222.38.32001 Boehringer Ingelheim Investigational Site
Leuven, Belgium
1222.38.32003 Boehringer Ingelheim Investigational Site
Liège, Belgium
Canada, British Columbia
1222.38.1082 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
Canada, Ontario
1222.38.1081 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1222.38.1083 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1222.38.1080 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Germany
1222.38.4980 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.38.4983 Boehringer Ingelheim Investigational Site
Dortmund, Germany
1222.38.4984 Boehringer Ingelheim Investigational Site
Großhansdorf, Germany
1222.38.4981 Boehringer Ingelheim Investigational Site
Kiel, Germany
1222.38.4986 Boehringer Ingelheim Investigational Site
Koblenz, Germany
1222.38.4985 Boehringer Ingelheim Investigational Site
Köln, Germany
Russian Federation
1222.38.7080 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1222.38.7081 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1222.38.7082 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01040793     History of Changes
Other Study ID Numbers: 1222.38, 2009-014416-35
Study First Received: December 29, 2009
Results First Received: March 28, 2014
Last Updated: July 4, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Russia: Pharmacological Committee, Ministry of Health

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 26, 2014