A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD - Full Text View

Purpose

The purpose of this study is to evaluate the safety and efficacy of the concomitant treatment of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide alone.

Condition	Intervention	Phase
COPD	Drug: Formoterol Fumarate Drug: Tiotropium Bromide	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:	A 6-Week Double-Blind, Parallel-Group, Active-Controlled Trial to Compare the Efficacy and Safety of Concomitant Treatment of 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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Formic acid Formoterol fumarate Formoterol Tiotropium bromide Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by Dey:

Primary Outcome Measures:

Measure of lung Function

Secondary Outcome Measures:

Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires

Estimated Enrollment:	128
Study Start Date:	April 2006
Study Completion Date:	December 2006
Primary Completion Date:	May 2006 (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:

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: NCT00308191

Locations

United States, Arizona
Research Site
Phoenix, Arizona, United States, 85006
United States, California
Research Site
Los Angeles, California, United States, 90095
Research Site
Sepulveda, California, United States, 91343
Research Site
Walnut Creek, California, United States, 94598
United States, Colorado
Research Site
Colorado Springs, Colorado, United States, 80907
United States, Florida
Research Site
Tamarac, Florida, United States, 33321
United States, Georgia
Research Site
Gainesville, Georgia, United States, 30501
United States, Maine
Research Site
Auburn, Maine, United States, 04210
United States, Michigan
Research Site
Ann Arbor, Michigan, United States, 48105
Research Site
Livonia, Michigan, United States, 48152
United States, Missouri
Research Site
St. Louis, Missouri, United States, 63141
United States, New York
Research Site
Liverpool, New York, United States, 13088
Research Site
Rochester, New York, United States, 14618
United States, Oregon
Research Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Research Site
Collegeville, Pennsylvania, United States, 19426
United States, Texas
Research Site
El Paso, Texas, United States, 79902
Research Site
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Dey

More Information

Publications:

Tashkin DP, Littner M, Andrews CP, Tomlinson L, Rinehart M, Denis-Mize K. Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: A placebo-controlled trial. Respir Med. 2008 Feb 6; [Epub ahead of print]

Responsible Party:	Director, Clinical Affairs, Dey L.P.
ClinicalTrials.gov Identifier:	NCT00308191 History of Changes
Other Study ID Numbers:	201-070
Study First Received:	March 27, 2006
Last Updated:	March 5, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dey:

COPD
Formoterol
Tiotropium

Additional relevant MeSH terms:

Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Bromides
Formoterol
Tiotropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists

Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 21, 2013