Study Evaluating the Effect of IMA-026 on Allergen-Induced Late Asthma Response in Mild Asthma
- Registration Number
- NCT00725582
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
The purpose of this study is to evaluate the effect of IMA-026, an antibody to IL-13, on airway hyperresponsiveness and airway inflammation in mild asthmatics. IMA-026 will be given as 2 injections under the skin 1 week apart at 2 mg/kg each dose. The study will include a screening period and a treatment period which includes doses on day 1 and day 8.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Healthy men and women 18 to 60 yrs with mild allergic asthma
- only asthma med is short-acting bronchodilator used not more than twice weekly
- FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction
Exclusion Criteria
- Upper respiratory infection or asthma exacerbation with 4 weeks of screening
- Serious infection requiring parenteral antibiotics or hospitalization with 4 weeks of test article administration
- Positive radiographic findings indicative of respiratory disease other than asthma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A IMA-026 - B Placebo -
- Primary Outcome Measures
Name Time Method Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo 11 weeks
- Secondary Outcome Measures
Name Time Method Treatment comparison of the hour 3 and hour 7 FEV1 AUC for the LAR; various comparisons of the methacholine PC20 11 weeks