Study of Oglemilast for the Treatment of Asthma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00322686
• Date of registration: 04/05/2006
• Primary sponsor: Forest Laboratories
• Public title: Study of Oglemilast for the Treatment of Asthma
• Scientific title: Efficacy and Safety of Oglemilast in the Prevention of Allergen-induced Bronchospasm
• Date of first enrolment: May 2006
• Target sample size: 6
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00322686
• 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

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Oglemilast

Drug: Placebo then Oglemilast

Primary Outcome(s)

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(s)

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]

Secondary ID(s)

GRC-MD-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors