Study in Subjects Greater Than 40 Years of Age With COPD - Full Text View

Purpose

This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled, parallel-group, comparative study.

The objectives of this study are:

To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.
To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice daily compared to tiotropium 18 mcg once daily.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: formoterol fumarate inhalation solution	Phase III

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease)

ChemIDplus related topics:

Tiotropium Tiotropium bromide Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A 6-Week Trial to Compare the Efficacy and Safety of Concomitant Treatment With Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Further study details as provided by Dey:

Primary Outcome Measures:

The primary efficacy endpoint will be the standardized area under the curve for FEV1 (FEV1 AUC0-3) over the 3-hour assessment period at End Study (Week 6/ET). [ Time Frame: 6 weeks ]

Estimated Enrollment:	128
Study Start Date:	March 2007

Eligibility

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

Criteria

Inclusion Criteria:

Medical diagnosis of COPD
Current or prior history of cigarette smoking

Exclusion Criteria:

Medical diagnosis of asthma
Significant condition or disease other than COPD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507234

Locations


United States, Alabama
	Clinical Research Site
	Mobile, Alabama, United States, 36695

United States, Arizona
	Clinical Research Site
	Phoenix, Arizona, United States, 85006

United States, Florida
	Clinical Research Site
	DeLand, Florida, United States, 32720

United States, Georgia
	Clinical Research Site
	Atlanta, Georgia, United States, 30330

United States, Michigan
	Clinical Research Site
	Livonia, Michigan, United States, 48152

United States, Missouri
	Clinical Research Site
	St. Louis, Missouri, United States, 63141
	Clinical Research Site
	St. Charles, Missouri, United States, 63301

United States, New York
	Clinical Research Site
	Williamsville, New York, United States, 14221
	Clinical Research Site
	Albany, New York, United States, 12205
	Clinical Research Site
	North Syracuse, New York, United States, 13212

United States, Ohio
	Clinical Research Site
	Toledo, Ohio, United States, 45560

United States, Oregon
	Clinical Research Site
	Medford, Oregon, United States, 97504
	Clinical Research Site
	Portland, Oregon, United States, 97213

United States, South Carolina
	Clinical Research Site
	Greenville, South Carolina, United States, 29615
	Clinical Research Site
	Spartanburg, South Carolina, United States, 29303

United States, Texas
	Clinical Research Site
	San Antonio, Texas, United States, 78229

United States, Virginia
	Clinical Research Site
	Richmond, Virginia, United States, 23225
	Clinical Research Site
	Abingdon, Virginia, United States, 24210

United States, Wisconsin
	Clinical Research Site
	Milwaukee, Wisconsin, United States, 53209

Sponsors and Collaborators

Dey

Investigators


Principal Investigator:	Nicola A Hanania, MD	Baylor College of Medicine

More Information

Responsible Party:	Dey ( Director, Clinical Affairs )
Study ID Numbers:	201-080
First Received:	July 24, 2007
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00507234
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dey:

COPD

Study placed in the following topic categories:

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Formoterol

Tiotropium

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents

Neurotransmitter Agents

Adrenergic beta-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anti-Asthmatic Agents

Adrenergic Agonists

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	Dey
Information provided by:	Dey
ClinicalTrials.gov Identifier:	NCT00507234