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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	March 27, 2006
Last Updated Date	March 5, 2008
Start Date ^†	April 2006
Current Primary Outcome Measures ^† (submitted: March 28, 2006)	Measure of lung Function
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00308191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: March 28, 2006)	Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD
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
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
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^†	COPD
Intervention ^†	Drug: Formoterol Fumarate Drug: Tiotropium Bromide
Study Arms / Comparison Groups
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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	128
Completion Date	December 2006
Primary Completion Date	May 2006 (final data collection date for primary outcome measure)
Eligibility 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
Gender	Both
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00308191
Responsible Party	Director, Clinical Affairs, Dey L.P.
Secondary IDs ^††
Study Sponsor ^†	Dey
Collaborators ^††
Investigators ^†
Information Provided By	Dey
Verification Date	March 2008
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.