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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941577
• Other study ID #: AIR645-CS2
• Status: Completed
• Phase: Phase 2
• First received: July 15, 2009
• Last updated: July 21, 2010
• Start date: October 2009
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: Altair Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• AIR645
AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
• Physiologic saline solution
Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Altair Therapeutics, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) of the percentage decrease forced expiratory volume in one second (FEV1) from baseline between AIR645 and placebo		36 days	No