12 / 48 wk Pivotal PFT vs PBO in COPD II

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00782509
First received: October 29, 2008
Last updated: May 4, 2011
Last verified: May 2011
  Purpose

This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 Mcg [2 Actuations of 2.5 Mcg] and 10 Mcg [2 Actuations of 5 Mcg]) Delivered by the Respimat® Inhaler, in Patients With Chronic Obstructive Pulmonary Disease (COPD

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The bronchodilator efficacy of BI 1744 CL will be primarily assessed using forced expiratory volume in one second (FEV1). The 2 co primary endpoints in this study are FEV1 AUC 0 3 response and trough FEV1 response. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FVC AUC0-3h response [ Time Frame: 2, 6.12, 24 and 48 weeks ] [ Designated as safety issue: No ]
  • trough FVC response [ Time Frame: 2,6,12,18,24,32,40 and 48 weeks ] [ Designated as safety issue: No ]
  • FEV1 peak0-3h response [ Time Frame: 2,6,12,24 and 48 weeks ] [ Designated as safety issue: No ]
  • FVC peak0-3h response [ Time Frame: 2,6,12,24,and 48 weeks ] [ Designated as safety issue: No ]
  • FEV1 response [L] at 5, 15 and 30 minutes, and at 1, 2 and 3 hours after inhalation of study medication, [ Time Frame: 2,6,12,24 and 48 weeks ] [ Designated as safety issue: No ]
  • .FVC response [L] at 5, 15 and 30 minutes, and at 1, 2 and 3 hours after inhalation of study medication, [ Time Frame: 2,6,12,24, and 48 weeks ] [ Designated as safety issue: No ]
  • FEV1 response [L] at 4, 5, 6, 8, 10 and 12 hours after inhalation of study medication, after 12 weeks (in the subset of patients with available data) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • FVC response [L] at 4, 5, 6, 8, 10 and 12 hours after inhalation of study medication, after 12 weeks (in the subset of patients with available data) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Weekly mean pre-dose morning and evening peak expiratory flow rates [ Time Frame: throughout trial ] [ Designated as safety issue: No ]
  • Weekly mean number of puffs of rescue medication used per day (daytime/nighttime/total) [ Time Frame: throughout trial ] [ Designated as safety issue: No ]
  • Patients Global Rating [ Time Frame: 6,12,24 and 48 weeks ] [ Designated as safety issue: No ]
  • Time to first COPD exacerbation [ Time Frame: Throughout trial ] [ Designated as safety issue: No ]
  • Time to first COPD exacerbation leading to hospitalization [ Time Frame: Throughout trial ] [ Designated as safety issue: No ]
  • FEV1 AUC0-3h response [ Time Frame: 2, 6,24 and 48 weeks ] [ Designated as safety issue: No ]
  • FEV1 trough response [ Time Frame: 2, 6, 18, 24, 32, 40 and 48 weeks ] [ Designated as safety issue: No ]
  • FEV1 AUC0-12h response after 12 weeks (in the subset of patients with available data) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of COPD exacerbations, per patient year [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Number of COPD exacerbations leading to hospitalization, per patient year [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • . Adverse events, including administration related bronchoconstriction [ Time Frame: throughout trial ] [ Designated as safety issue: Yes ]
  • Vital signs: pulse rate and blood pressure [ Time Frame: weeks 2,6,12,18,24,32,40,48 ] [ Designated as safety issue: Yes ]
  • . Routine blood chemistry, haematology and urinalysis [ Time Frame: 6,12,24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • 12-lead ECG [ Time Frame: weeks 6,12,24, and 48 ] [ Designated as safety issue: Yes ]
  • 24-hour Holter monitoring (in a subset of 150 patients [ Time Frame: 12, 24, 40 and 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 644
Study Start Date: February 2009
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olodaterol (BI1744) Low
Low dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744)
Comparison of low and high doses on efficacy and safety in COPD patients
Placebo Comparator: Placebo
Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler
Drug: Placebo
Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler
Experimental: Olodaterol (BI 1744) High
High dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744)
Comparison of low and high doses on efficacy and safety in COPD patients

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • All patients must have a diagnosis of chronic obstructive pulmonary disease
  • Male or female patients, 40 years of age or older Patients must be current or ex-smokers with a smoking history of more than 10 pack years Post bronchodilator FEV1 <80% predicted and post-bronchodilator FEV1/FVC <70%

Exclusion criteria:

  • Patients with a significant disease other than COPD
  • Patients with a history of asthma
  • Patients with any of the following conditions:

a history of myocardial infarction within 1 year of screening visit (Visit 1) unstable or life-threatening cardiac arrhythmia. have been hospitalized 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 (patients with treated basal cell carcinoma are allowed) a history of life-threatening pulmonary obstruction a history of cystic fibrosis

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782509

  Show 51 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00782509     History of Changes
Other Study ID Numbers: 1222.12, 2008-003704-67
Study First Received: October 29, 2008
Last Updated: May 4, 2011
Health Authority: China: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Taiwan: Department of Health, Executive Yuan, Taiwan
United States: Food and Drug Administration

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 April 17, 2014