A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD

This study has been completed.

Sponsor:

Information provided by:

Dey

ClinicalTrials.gov Identifier:

NCT00215436

First received: September 13, 2005

Last updated: November 9, 2010

Last verified: April 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	September 13, 2005
Last Updated Date	November 9, 2010
Start Date ^ICMJE	March 2005
Primary Completion Date	September 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 15, 2005)	Measure of lung function
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00215436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 15, 2005)	Change in lung function, as well as vital signs Physical Exam results, Adverse event reporting, etc
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 Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD
Official Title ^ICMJE	A 12-week Double-Blind, Parallel-Group, Placebo- and Active- Controlled Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate Inhalation Solution 20 Mcg in the Treatment of Patients With Chronic Obstructive Pulmonary Disease
Brief Summary	The purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.
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
Study Arm (s)	Not Provided
Publications *	Nelson HS, Gross NJ, Levine B, Kerwin EM, Rinehart M, Denis-Mize K, Formoterol Study Group. Cardiac safety profile of nebulized formoterol in adults with COPD: a 12-week, multicenter, randomized, double- blind, double-dummy, placebo- and active-controlled trial. Clin Ther. 2007 Oct;29(10):2167-78. Gross NJ, Nelson HS, Lapidus RJ, Dunn L, Lynn L, Rinehart M, Denis-Mize K; Formoterol Study Group. Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients. Respir Med. 2008 Feb;102(2):189-97.
* 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	345
Completion Date	September 2006
Primary Completion Date	September 2005 (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 Chest X-ray diagnostic of significant disease other than COPD 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	NCT00215436
Other Study ID Numbers ^ICMJE	201-065
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	April 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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