Study of Oglemilast for the Prevention of Asthma.

This study has been completed.

Sponsor:

Information provided by:

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT00322283

First received: May 4, 2006

Last updated: April 7, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	May 4, 2006
Last Updated Date	April 7, 2012
Start Date ^ICMJE	May 2006
Primary Completion Date	October 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 4, 2006)	To determine the efficacy of oglemilast as compared to placebo in preventing exercise-induced asthma following 15 days of treatment.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00322283 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 4, 2006)	To evaluate the safety of oglemilast over 2 weeks as determined by adverse events, physical examinations, vital signs, electrocardiograms, and laboratory examinations.
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 of Oglemilast for the Prevention of Asthma.
Official Title ^ICMJE	Efficacy and Safety of Oglemilast in the Prevention of Exercise-Induced Bronchospasm
Brief Summary	The purpose of this study is to determine whether it is effective in the treatment of exercise-induced asthma and investigate the safety of oglemilast.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Exercise-Induced Asthma
Intervention ^ICMJE	Drug: Oglemilast Oglemilast, 15mg once per day, oral administration Drug: Placebo Dose-marched placebo, once per day, oral administration
Study Arm (s)	Experimental: Oglemilast Intervention: Drug: Oglemilast Placebo Comparator: Placebo Intervention: Drug: Placebo
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	24
Completion Date	October 2006
Primary Completion Date	October 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: stable mild asthma patients who exhibit at least a 20% decrease in FEV1 following exercise. Exclusion Criteria: pulmonary disease other than asthma, psychiatric illness, active cardiac disease, high blood pressure, history of substance abuse, current smokers.
Gender	Both
Ages	18 Years to 50 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	NCT00322283
Other Study ID Numbers ^ICMJE	GRC-MD-01
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Forest Laboratories
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Forest Laboratories
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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