NCT01040130

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
4 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

July 8, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

December 28, 2009

Results QC Date

March 28, 2014

Last Update Submit

July 4, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Adjusted Mean Endurance Time After 6 Weeks

    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.

    6 weeks

Secondary Outcomes (23)

  • Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks

    6 weeks

  • Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks

    6 weeks

  • Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks

    6 weeks

  • Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks

    6 weeks

  • Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks

    6 weeks

  • +18 more secondary outcomes

Study Arms (3)

Olodaterol (BI 1744) Low

EXPERIMENTAL

Low dose inhaled orally once daily from the Respimat inhaler

Drug: Olodaterol (BI 1744)Drug: Olodaterol (BI 1744) Placebo

Olodaterol (BI 1744) High

EXPERIMENTAL

High dose inhaled orally once daily from the Respimat inhaler

Drug: Olodaterol (BI 1744)

Placebo

PLACEBO COMPARATOR

Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler

Drug: Placebo

Interventions

Olodaterol (BI 1744)DRUG

Comparison of low and high doses on exercise endurance time in COPD patients

Olodaterol (BI 1744) High
PlaceboDRUG

Comparison of low and high dose and placebo on exercise endurance time in COPD patients

Placebo
Olodaterol (BI 1744) PlaceboDRUG

Placebo that represents olodaterol

Olodaterol (BI 1744) Low

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent prior to participation.
  • 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.
  • Male or female between 40 and 75 years of age.
  • Current or ex-smokers with smoking history of more than 10-pack years.
  • Able to perform technically acceptable pulmonary function tests, multiple exercise tests and able to maintain records.
  • Able to inhale medication in a competent manner from a metered-dose inhaler and Respimat inhaler.

You may not qualify if:

  • 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.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

1222.37.6171 Boehringer Ingelheim Investigational Site

Daw Park, South Australia, Australia

Location

1222.37.6174 Boehringer Ingelheim Investigational Site

Clayton, Victoria, Australia

Location

1222.37.6173 Boehringer Ingelheim Investigational Site

Heidelberg, Victoria, Australia

Location

1222.37.6172 Boehringer Ingelheim Investigational Site

Melbourne, Victoria, Australia

Location

1222.37.4371 Boehringer Ingelheim Investigational Site

Gänserndorf, Austria

Location

1222.37.4372 Boehringer Ingelheim Investigational Site

Neumarkt am Wallersee, Austria

Location

1222.37.1072 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1222.37.1074 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1222.37.1073 Boehringer Ingelheim Investigational Site

Ste-Foy, Quebec, Canada

Location

1222.37.33005 Boehringer Ingelheim Investigational Site

Béthune, France

Location

1222.37.33002 Boehringer Ingelheim Investigational Site

Montpellier, France

Location

1222.37.33001 Boehringer Ingelheim Investigational Site

Nîmes, France

Location

1222.37.33006 Boehringer Ingelheim Investigational Site

Paris, France

Location

1222.37.33004 Boehringer Ingelheim Investigational Site

Perpignan, France

Location

1222.37.33003 Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

1222.37.4970 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.37.4972 Boehringer Ingelheim Investigational Site

Halle, Germany

Location

1222.37.4973 Boehringer Ingelheim Investigational Site

Magdeburg, Germany

Location

1222.37.4971 Boehringer Ingelheim Investigational Site

Rüdersdorf, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27383762DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

olodaterol

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2009

First Posted

December 29, 2009

Study Start

January 1, 2010

Primary Completion

April 1, 2011

Last Updated

July 8, 2014

Results First Posted

July 8, 2014

Record last verified: 2014-07

Locations

AU(4)FR(6)DE(4)CA(3)