Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

This study is currently recruiting participants.

Verified by Boehringer Ingelheim Pharmaceuticals, August 2009

First Received: July 2, 2009 Last Updated: August 20, 2009 History of Changes

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00932646

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 5 mcg once daily Drug: BI 1744 10 mcg once daily Drug: Foradil 12 mcg twice daily	Phase III

Study Type:	Interventional
Study Design:	Treatment, Crossover Assignment, Safety/Efficacy Study
Official Title:	Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in 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 Arformoterol 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 ]

Secondary Outcome Measures:

The key 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. Additional pulmonary and safety measures [ Time Frame: 6 Weeks ]

Estimated Enrollment:	100
Study Start Date:	June 2009
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

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: NCT00932646

Contacts

Contact: Boehringer Ingelheim Study Coordinator

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Locations

United States, Alabama
1222.25.25001 Boehringer Ingelheim Investigational Site	Not yet recruiting
Birmingham, Alabama, United States
1222.25.25009 Boehringer Ingelheim Investigational Site	Recruiting
Jasper, Alabama, United States
United States, Florida
1222.25.25003 Boehringer Ingelheim Investigational Site	Recruiting
Deland, Florida, United States
1222.25.25002 Boehringer Ingelheim Investigational Site	Recruiting
Clearwater, Florida, United States
1222.25.25007 Boehringer Ingelheim Investigational Site	Recruiting
Winter Park, Florida, United States
United States, Georgia
1222.25.25010 Boehringer Ingelheim Investigational Site	Not yet recruiting
Austell, Georgia, United States
United States, New Mexico
1222.25.25008 Boehringer Ingelheim Investigational Site	Recruiting
Albuquerque, New Mexico, United States
United States, North Carolina
1222.25.25012 Boehringer Ingelheim Investigational Site	Recruiting
Charlotte, North Carolina, United States
1222.25.25004 Boehringer Ingelheim Investigational Site	Recruiting
Raleigh, North Carolina, United States
United States, Ohio
1222.25.25011 Boehringer Ingelheim Investigational Site	Recruiting
Columbus, Ohio, United States
United States, South Carolina
1222.25.25014 Boehringer Ingelheim Investigational Site	Recruiting
Seneca, South Carolina, United States
United States, Tennessee
1222.25.25006 Boehringer Ingelheim Investigational Site	Recruiting
Knoxville, Tennessee, United States
United States, Texas
1222.25.25005 Boehringer Ingelheim Investigational Site	Recruiting
Houston, Texas, United States
United States, Virginia
1222.25.25013 Boehringer Ingelheim Investigational Site	Recruiting
Richmond, Virginia, 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 ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1222.25
Study First Received:	July 2, 2009
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00932646 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic Agents
Adrenergic beta-Agonists
Respiration Disorders
Anti-Asthmatic Agents
Adrenergic Agonists
Lung Diseases, Obstructive

Respiratory Tract Diseases
Lung Diseases
Formoterol
Chronic Disease
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Disease Attributes
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Adrenergic Agents
Physiological Effects of Drugs
Respiration Disorders
Anti-Asthmatic Agents
Pharmacologic Actions
Adrenergic Agonists

Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Formoterol
Chronic Disease
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 10, 2009