Study Evaluating the Effects of AIR645 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: AIR645; Drug: Physiologic saline solution

• Registration Number: NCT00941577
• Lead Sponsor: Altair Therapeutics, Inc.

Brief Summary

To assess the efficacy of inhaled AIR645 in the suppression of the Asthmatic Responses in subjects with mild asthma inhaling an allergen.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-15
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Study Start: 2009-10
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-21
• Last Update Posted: 2010-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Men and women with well controlled mild allergic asthma, aged 18 to 65 years
• 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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIR645	AIR645	AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution)
Physiologic saline solution	Physiologic saline solution	Physiologic saline solution

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) of the percentage decrease forced expiratory volume in one second (FEV1) from baseline between AIR645 and placebo	36 days