Study of Oglemilast for the Treatment of Asthma

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT00322686

First received: May 4, 2006

Last updated: March 16, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	May 4, 2006
Last Updated Date	March 16, 2012
Start Date ^ICMJE	May 2006
Primary Completion Date	December 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 16, 2012)	To determine the effect of oglemilast in the prevention of bronchoconstriction after the administration of allergen, in comparison with placebo in patients with mild asthma [ Time Frame: From Baseline to Day 7 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: May 4, 2006)	To determine the effect of oglemilast in the prevention of bronchoconstriction after the administration of allergen, in comparison with placebo in patients with mild asthma.
Change History	Complete list of historical versions of study NCT00322686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 16, 2012)	To evaluate the safety of oglemilast over 2 weeks as determined by adverse events,physical examinations, vital signs, electrocardiograms, and laboratory examinations [ Time Frame: From Baseline to Day 14 ] [ Designated as safety issue: Yes ]
Original 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.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Oglemilast for the Treatment of Asthma
Official Title ^ICMJE	Efficacy and Safety of Oglemilast in the Prevention of Allergen-induced Bronchospasm
Brief Summary	The purpose of this study is to determine whether oglemilast is safe and effective in the treatment of allergen-induced asthma.
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 (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Asthma
Intervention ^ICMJE	Drug: Oglemilast Oglemilast, 15mg oral administration, once per day and then dose-matched placebo Drug: Placebo then Oglemilast Dose-matched placebo and then Oglemilast, 15mg, oral administration, once per day.
Study Arm (s)	Experimental: Oglemilast followed by placebo Intervention: Drug: Oglemilast Experimental: Placebo followed by Oglemilast Intervention: Drug: Placebo then Oglemilast
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	6
Completion Date	Not Provided
Primary Completion Date	December 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Mild atopic asthma Hyperreactivity to methacholine Exhibit positive response to standard allergen skin prick test Exclusion Criteria: Pulmonary disease other than asthma Asthma exacerbation within 4 weeks History of substance abuse Active cardiac disease
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	NCT00322686
Other Study ID Numbers ^ICMJE	GRC-MD-03
Has Data Monitoring Committee	No
Responsible Party	Forest Laboratories
Study Sponsor ^ICMJE	Forest Laboratories
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Forest Laboratories
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top