12 / 48 wk Pivotal PFT vs PBO in COPD II - 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).

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:

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 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 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:	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 June 18, 2013