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NCT00308191 Clinical Trial

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

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00308191
Other study ID # 201-070
Secondary ID
Status Completed
Phase Phase 3
First received March 27, 2006
Last updated March 5, 2008
Start date April 2006
Est. completion date December 2006

Study information
Verified date March 2008
Source Dey
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 128
Est. completion date December 2006
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Formoterol Fumarate

• Tiotropium Bromide

Locations
Country Name City State
United States Research Site Ann Arbor Michigan
United States Research Site Auburn Maine
United States Research Site Collegeville Pennsylvania
United States Research Site Colorado Springs Colorado
United States Research Site El Paso Texas
United States Research Site Gainesville Georgia
United States Research Site Liverpool New York
United States Research Site Livonia Michigan
United States Research Site Los Angeles California
United States Research Site Medford Oregon
United States Research Site Phoenix Arizona
United States Research Site Rochester New York
United States Research Site San Antonio Texas
United States Research Site Sepulveda California
United States Research Site St. Louis Missouri
United States Research Site Tamarac Florida
United States Research Site Walnut Creek California

Sponsors (1)
Lead Sponsor Collaborator
Dey

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Apr;102(4):479-87. doi: 10.1016/j.rmed.2007.12.019 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Measure of lung Function
Secondary Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires
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