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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
  Purpose

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


Condition Intervention Phase
Asthma
 Drug: Oglemilast
Drug: Placebo then Oglemilast
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Oglemilast in the Prevention of Allergen-induced Bronchospasm

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 6
Study Start Date: May 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322686

Locations
United States, California
Forest Investigative Site
Los Angeles, California, United States, 90025
Sponsors and Collaborators
Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00322686     History of Changes
Other Study ID Numbers: GRC-MD-03
Study First Received: May 4, 2006
Last Updated: March 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
oglemilast
asthma
allergen
 prevention
prophylaxis
Allergen-Induced Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013