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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: IMA-026; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00725582

3192K1-1002

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: IMA-026

B

Placebo Comparator group

Treatment:

Other: Placebo