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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00308191
First Posted: March 29, 2006
Last Update Posted: March 7, 2008
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.
Information provided by:
Dey
March 27, 2006
March 29, 2006
March 7, 2008
April 2006
May 2006   (Final data collection date for primary outcome measure)
Measure of lung Function
Same as current
Complete list of historical versions of study NCT00308191 on ClinicalTrials.gov Archive Site
Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires
Same as current
Not Provided
Not Provided
 
A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
COPD
  • Drug: Formoterol Fumarate
  • Drug: Tiotropium Bromide
Not Provided
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. Epub 2008 Feb 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
December 2006
May 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00308191
201-070
Not Provided
Not Provided
Not Provided
Director, Clinical Affairs, Dey L.P.
Dey
Not Provided
Not Provided
Dey
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP