12 / 48 Week Pivotal PFT vs PBO in COPD I - Full Text View

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).

The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also be compared to placebo.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Olodaterol (BI1744) 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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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 AUC 0-3h 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 peak 0-3h response [ Time Frame: 2,6,12,24,and 48 weeks ] [ Designated as safety issue: No ]
FVC peak 0-3h response [ Time Frame: 2,6,12,24,and 48 weeks ] [ Designated as safety issue: No ]
FEV1 response at 5,15,30minutes and 1,2,3 hours after inhalation of study medication [ Time Frame: 2,6,12,24 and 48 weeks ] [ Designated as safety issue: No ]
FVC response at 5,15,30 minutes and 1,2,3 hours after inhalation of study medication [ Time Frame: 2,6,12,24,and 48 weeks ] [ Designated as safety issue: No ]
FEV1 response at 4,5,6,8,10 and 12 hours after inhalation of study medication in subset of patients [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
FVC response at 4,5,6,8,10, and 12 hours after inhalation of study medication in subset of patients [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Weekly mean pre-dose morning and evening peak expiratory flow rates [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
Weekly mean number of puffs of rescue medication used per day (daytime/nighttime/total) [ Time Frame: duration of 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: duration of trial ] [ Designated as safety issue: No ]
Time to first COPD exacerbation leading to hospitalization [ Time Frame: duration of trial ] [ 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 per patient year leading to hospitalization [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
adverse events including administration related bronchoconstriction [ Time Frame: duration of 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, hematology and urinalysis [ Time Frame: 6,12,24,48 weeks ] [ Designated as safety issue: Yes ]
12 lead ECG [ Time Frame: week 6,12,24 and 48 ] [ Designated as safety issue: Yes ]
24 hour holter monitoring (in a subset of patients) [ Time Frame: 12,24,40,48 weeks ] [ Designated as safety issue: Yes ]
FEV1 AUC 0-3h 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 AUC 0-12h response after 12 weeks (in subset of patients) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	625
Study Start Date:	November 2008
Primary Completion Date:	September 2010 (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 (BI1744) Comparison of low and high doses on efficacy and safety in COPD patients
Experimental: Olodaterol (BI 1744) High High dose inhaled orally once daily from the Respimat inhaler	Drug: Olodaterol (BI1744) Comparison of low and high doses on efficacy and safety in COPD patients
Placebo Comparator: Placebo Olodaterol (BI1744) placebo inhaled orally once daily from the Respimat inhaler	Drug: placebo Olodaterol (BI1744) placebo inhaled orally once daily from the Respimat inhaler

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: NCT00782210

Show 54 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00782210 History of Changes
Other Study ID Numbers:	1222.11, 2008-003647-36
Study First Received:	October 29, 2008
Last Updated:	May 4, 2011
Health Authority:	Australia: Dept of Health and Ageing Therapeutic Goods Admin China: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices New Zealand: Multi-Regional Ethics Committee / Medsafe 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 May 21, 2013