NCT01040793

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

90
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
5 countries

19 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 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2009

Completed
2 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 29, 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 (BI1744)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 orally from the Respimat inhaler

Drug: Placebo

Interventions

Olodaterol (BI 1744)DRUG

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

Olodaterol (BI 1744) Low
PlaceboDRUG

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

Placebo
Olodaterol (BI1744)DRUG

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

Olodaterol (BI 1744) Low
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)

1222.38.4380 Boehringer Ingelheim Investigational Site

Hallein, Austria

Location

1222.38.4381 Boehringer Ingelheim Investigational Site

Leoben, Austria

Location

1222.38.32004 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1222.38.32002 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1222.38.32001 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1222.38.32003 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1222.38.1082 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1222.38.1081 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1222.38.1083 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1222.38.1080 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1222.38.4980 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.38.4985 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

1222.38.4983 Boehringer Ingelheim Investigational Site

Dortmund, Germany

Location

1222.38.4984 Boehringer Ingelheim Investigational Site

Großhansdorf, Germany

Location

1222.38.4981 Boehringer Ingelheim Investigational Site

Kiel, Germany

Location

1222.38.4986 Boehringer Ingelheim Investigational Site

Koblenz, Germany

Location

1222.38.7080 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1222.38.7081 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1222.38.7082 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

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 29, 2009

First Posted

December 30, 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(2)DE(6)CA(4)RU(3)BE(4)