Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease - Full Text View

Purpose

The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: BI 1744 Drug: bi1744 Drug: Placebo Drug: Foradil	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil Iin Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Formoterol fumarate Formoterol Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The primary objective will be to evaluate whether once daily treatment with 5 mcg or 10 mcg BI 1744 administered via the Respimat device is superior to once daily treatment with Placebo Respimat using FEV1 AUC values [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Additional Pulmonary Measures with FEV1, FVC, FEV1 AUC. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Vital Signs [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Clinical Labs [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
ECG [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
The secondary objective will be to compare once daily treatment with 5 mcg or 10 mcg BI 1744 administered via the Respimat device to twice daily treatment with Foradil Aerolizer using FEV1 AUC values. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	99
Study Start Date:	June 2009
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BI 1744 (Olodaterol) Low Dose BI1744 Low Dose once daily	Drug: bi1744 1744 low dose
Experimental: BI 1744 (Olodaterol) Med Dose BI 1744 Med Dose once daily	Drug: BI 1744 BI1744 Respimat Med Dose Once Daily
Placebo Comparator: Placebo Placebo once daily	Drug: Placebo Placebo Respimat and Foradil Placebo
Active Comparator: Foradil Foradil 12 mcg twice daily	Drug: Foradil Foradil 12 mcg twice daily and Placebo Respimat

Eligibility

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

Criteria

Inclusion Criteria:

Patients willing to participate with confirmed diagnosis of COPD
40 years of age or older
having a 10 pack year smoking history
able to perform serial pulmonary function tests
able to use both a DPI and Respimat device

Exclusion Criteria:

Significant other disease
clinically relevant abnormal hematology, chemistry, or urinalysis
history of asthma
diagnosis of thyrotoxicosis
paroxysmal tachycardia related to beta agonists
history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
significant alcohol or drug use
pulmonary resection
taking oral beta adrenergics
taking unstable oral steroids
daytime oxygen
enrolled in rehabilitation program
enrolled in another study or taking investigational products
pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
those who are not willing to comply with pulmonary medication washouts

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931385

Locations

United States, Florida
1222.24.24011 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
United States, Kansas
1222.24.24009 Boehringer Ingelheim Investigational Site
Overland Park, Kansas, United States
United States, Louisiana
1222.24.24007 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana, United States
United States, Ohio
1222.24.24002 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
United States, Oklahoma
1222.24.24010 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, South Carolina
1222.24.24004 Boehringer Ingelheim Investigational Site
Easley, South Carolina, United States
1222.24.24006 Boehringer Ingelheim Investigational Site
Gaffney, South Carolina, United States
1222.24.24008 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1222.24.24005 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1222.24.24001 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
1222.24.24003 Boehringer Ingelheim Investigational Site
Union, South Carolina, United States

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:	NCT00931385 History of Changes
Other Study ID Numbers:	1222.24
Study First Received:	July 1, 2009
Last Updated:	November 15, 2010
Health Authority:	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
Formoterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013