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Study of Oglemilast for the Treatment of Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00322686
First Posted: May 8, 2006
Last Update Posted: March 20, 2012
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.
Information provided by (Responsible Party):
Forest Laboratories
  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
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

Resource links provided by NLM:


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 ]

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 ]

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

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.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00322686


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

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00322686     History of Changes
Other Study ID Numbers: GRC-MD-03
First Submitted: May 4, 2006
First Posted: May 8, 2006
Last Update Posted: March 20, 2012
Last Verified: March 2012

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