A Crossover Study in the Treatment of Patients With COPD - Full Text View

Sponsor:	Dey
Information provided by:	Dey
ClinicalTrials.gov Identifier:	NCT00462540

Purpose

The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare the preference/compliance of BID nebulization to QID use of MDI

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Formoterol Fumurate inhalation solution 20 mcg Drug: Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Albuterol Ipratropium bromide Formoterol fumarate Levalbuterol hydrochloride Albuterol sulfate Ipratropium Arformoterol Formoterol Arformoterol Tartrate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Dey:

Primary Outcome Measures:

Lung function after 2 weeks of treatment

Secondary Outcome Measures:

Lung function at each time point, patient questionnaires, medication compliance,
adverse events, clinical labs, vital signs, ECGs, physical exams

Estimated Enrollment:	100
Study Start Date:	May 2007
Study Completion Date:	October 2007
Primary Completion Date:	September 2007 (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:

Diagnosis of COPD
Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day
Meet lung function requirements

Exclusion Criteria:

Diagnosis of Asthma
Significant disease other than COPD
Female pregnant or lactating or planning to become pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462540

Locations

United States, California
Research Site
San Diego, California, United States, 92120
United States, Colorado
Research Site
Wheat Ridge, Colorado, United States, 80033
Research Site
Denver, Colorado, United States, 80206
United States, Florida
Research Site
Pensacola, Florida, United States, 32504
Research Site
Panama City, Florida, United States, 32405
United States, Idaho
Research Site
Coeur d'Alene, Idaho, United States, 83814
United States, Louisiana
Research Site
Sunset, Louisiana, United States, 70584
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28207
United States, Oregon
Research Site
Portland, Oregon, United States, 97213
United States, South Carolina
Research Site
Spartanburg, South Carolina, United States, 29303
Research Site
Gaffney, South Carolina, United States, 29340
United States, Tennessee
Research Site
Johnson City, Tennessee, United States, 37601
United States, Texas
Research Site
San Antonio, Texas, United States, 78205
United States, Washington
Research Site
Spokane, Washington, United States, 99204
United States, West Virginia
Research Site
Morgantown, West Virginia, United States, 26505

Sponsors and Collaborators

Dey

More Information

Publications:

Sutherland ER, Brazinsky S, Feldman G, McGinty J, Tomlinson L, Denis-Mize K. Nebulized formoterol effect on bronchodilation and satisfaction in COPD patients compared to QID ipratropium/albuterol MDI *. Curr Med Res Opin. 2009 Mar;25(3):653-61.

Responsible Party:	Dey ( Director, Clinical Affairs )
Study ID Numbers:	201-081
Study First Received:	April 17, 2007
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00462540 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dey:

COPD
Formoterol
Ipratropium
Crossover

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic beta-Agonists
Albuterol
Physiological Effects of Drugs
Anti-Asthmatic Agents
Reproductive Control Agents
Cholinergic Agents
Adrenergic Agonists

Pharmacologic Actions
Lung Diseases, Obstructive
Tocolytic Agents
Respiratory Tract Diseases
Ipratropium
Autonomic Agents
Therapeutic Uses
Lung Diseases
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010