Study in Patients With COPD

This study has been completed.

Sponsor:

Information provided by:

Dey

ClinicalTrials.gov Identifier:

NCT00215423

First received: September 13, 2005

Last updated: November 10, 2010

Last verified: August 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	September 13, 2005
Last Updated Date	November 10, 2010
Start Date ^ICMJE	Not Provided
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 14, 2005)	Measure of lung function
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00215423 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 14, 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	Study in Patients With COPD
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to determine which dose of the investigational drug is the most safe and effective for the treatment of COPD compared to the control drug
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	COPD Chronic Obstructive Pulmonary Disease
Intervention ^ICMJE	Drug: Formoterol Fumarate
Study Arm (s)	Not Provided
Publications *	Gross NJ, Kerwin E, Levine B, Kim KT, Denis-Mize K, Hamzavi M, Carpenter M, Rinehart M. Nebulized formoterol fumarate: Dose selection and pharmacokinetics. Pulm Pharmacol Ther. 2008 Jul 8; [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	49
Completion Date	September 2005
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diagnosis of COPD History of cigarette smoking Exclusion Criteria: Clinical diagnosis of asthma Significant pulmonary disease other than COPD Other significant major organ disease(s)
Gender	Both
Ages	5 Years to 70 Years
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	NCT00215423
Other Study ID Numbers ^ICMJE	DL-057
Has Data Monitoring Committee	Not Provided
Responsible Party	Director, Clinical Affairs, Dey
Study Sponsor ^ICMJE	Dey
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Dey
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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