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Study of Oglemilast for the Treatment of Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00322686
Recruitment Status : Completed
First Posted : May 8, 2006
Last Update Posted : March 20, 2012
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
The purpose of this study is to determine whether oglemilast is safe and effective in the treatment of allergen-induced asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: Oglemilast Drug: Placebo then Oglemilast Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Oglemilast in the Prevention of Allergen-induced Bronchospasm
Study Start Date : May 2006
Actual Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Oglemilast followed by placebo Drug: Oglemilast
Oglemilast, 15mg oral administration, once per day and then dose-matched placebo

Experimental: Placebo followed by Oglemilast Drug: Placebo then Oglemilast
Dose-matched placebo and then Oglemilast, 15mg, oral administration, once per day.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00322686

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United States, California
Forest Investigative Site
Los Angeles, California, United States, 90025
Sponsors and Collaborators
Forest Laboratories
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Responsible Party: Forest Laboratories Identifier: NCT00322686    
Other Study ID Numbers: GRC-MD-03
First Posted: May 8, 2006    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012
Keywords provided by Forest Laboratories:
Allergen-Induced Asthma
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases