Study Evaluating the Effect of IMA-026 on Allergen-Induced Late Asthma Response in Mild Asthma

Asthma Clinical Trial

Official title:

The Effects of IMA-026 on Allergen-Induced Airway Responses and Airway Inflammation in Subjects With Mild Atopic Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725582
• Other study ID #: 3192K1-1002
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2008
• Last updated: June 1, 2009
• Start date: September 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Healthy men and women 18 to 60 yrs with mild allergic asthma

2. only asthma med is short-acting bronchodilator used not more than twice weekly

3. FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction

Exclusion Criteria:

1. Upper respiratory infection or asthma exacerbation with 4 weeks of screening

2. Serious infection requiring parenteral antibiotics or hospitalization with 4 weeks of test article administration

3. Positive radiographic findings indicative of respiratory disease other than asthma

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• IMA-026

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo		11 weeks	No
Secondary	Treatment comparison of the hour 3 and hour 7 FEV1 AUC for the LAR; various comparisons of the methacholine PC20		11 weeks	No