Study in Patients With Asthma

This study has been completed.

Sponsor:

Information provided by:

Dey

ClinicalTrials.gov Identifier:

NCT00215371

First received: September 13, 2005

Last updated: November 10, 2010

Last verified: February 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	September 13, 2005
Last Updated Date	November 10, 2010
Start Date ^ICMJE	July 2002
Primary Completion Date	October 2002 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 14, 2005)	Primary: The primary efficacy outcome is measure of lung function.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00215371 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 14, 2005)	Secondary: Change in lung function will be examined as a secondary efficacy outcome, as well as vital signs, physical examination, 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 Asthma
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group.
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	Asthma
Intervention ^ICMJE	Drug: Formoterol Fumarate
Study Arm (s)	Not Provided
Publications *	Not Provided
* 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	32
Completion Date	November 2005
Primary Completion Date	October 2002 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Require the regular use of an inhaled beta-2-selective adrenergic agent. No clinically significant abnormalities on the medical history, physical examination, and clinical laboratory tests. Exclusion Criteria: Active acute or chronic disorders of the respiratory system within one month prior to screening. Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history. Debilitating systemic and/or life-threatening diseases.
Gender	Both
Ages	5 Years to 11 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	NCT00215371
Other Study ID Numbers ^ICMJE	DL-050
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	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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