Official Title: “A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Bronchial Allergen Challenge Study to Assess the Safety, Tolerability, and Efficacy of Inhaled AIR645 in Subjects With Mild Allergic Asthma”
To assess the efficacy of inhaled AIR645 in the suppression of the Asthmatic Responses in subjects with mild asthma inhaling an allergen.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: May 2010
Interventions Used in this Clinical Trial
- Drug: AIR645
- AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
- Drug: Physiologic saline solution
- Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: AIR645
- AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution)
- Placebo Comparator: Physiologic saline solution
- Physiologic saline solution
Outcome Measures for this Clinical Trial
- Area under the curve (AUC) of the percentage decrease forced expiratory volume in one second (FEV1) from baseline between AIR645 and placebo
- Time Frame: 36 days
Safety Issue?: No
- Time Frame: 36 days
Criteria for Participation in this Clinical Trial
- 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial: No
Clinical Trial Investigator Information
- Lead Sponsor
- Altair Therapeutics, Inc.
- Provider of Information About this Clinical Study
- Mike Hodges, MD – Chief Medical Officer, Altair Therapeutics Inc.
- Overall Official(s)
- Mike Hodges, MD, Study Director, Altair Therapeutics, Inc.