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
  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:


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
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, see Learn About Clinical Studies.

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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014