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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308191
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : March 7, 2008
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
COPD Drug: Formoterol Fumarate Drug: Tiotropium Bromide Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 2006
Actual Primary Completion Date : May 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Measure of lung Function

Secondary Outcome Measures :
  1. Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308191

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

Publications of Results:
Responsible Party: Director, Clinical Affairs, Dey L.P. Identifier: NCT00308191     History of Changes
Other Study ID Numbers: 201-070
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: March 7, 2008
Last Verified: March 2008

Keywords provided by Dey:

Additional relevant MeSH terms:
Formoterol Fumarate
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents