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

This study has been completed.

Sponsor:

Information provided by:

Dey

ClinicalTrials.gov Identifier:

NCT00308191

First received: March 27, 2006

Last updated: March 5, 2008

Last verified: March 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	March 27, 2006
Last Updated Date	March 5, 2008
Start Date ^ICMJE	April 2006
Primary Completion Date	May 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 27, 2006)	Measure of lung Function
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00308191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 27, 2006)	Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	COPD
Intervention ^ICMJE	Drug: Formoterol Fumarate Drug: Tiotropium Bromide
Study Arm (s)	Not Provided
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]
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	128
Completion Date	December 2006
Primary Completion Date	May 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00308191
Other Study ID Numbers ^ICMJE	201-070
Has Data Monitoring Committee	Not Provided
Responsible Party	Director, Clinical Affairs, Dey L.P.
Study Sponsor ^ICMJE	Dey
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Dey
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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