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

This study has been completed.
Sponsor:
Information provided by:
Altair Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00941577
First received: July 15, 2009
Last updated: July 21, 2010
Last verified: July 2010
  Purpose

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


Condition Intervention Phase
Asthma
Drug: AIR645
Drug: Physiologic saline solution
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Altair Therapeutics, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIR645
AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution)
Drug: AIR645
AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Placebo Comparator: Physiologic saline solution
Physiologic saline solution
Drug: Physiologic saline solution
Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941577

Locations
Canada, Ontario
Hamilton, Ontario, Canada
Canada, Quebec
Laval, Quebec, Canada
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
Altair Therapeutics, Inc.
Investigators
Study Director: Mike Hodges, MD Altair Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Mike Hodges, MD - Chief Medical Officer, Altair Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00941577     History of Changes
Other Study ID Numbers: AIR645-CS2
Study First Received: July 15, 2009
Last Updated: July 21, 2010
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Altair Therapeutics, Inc.:
Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 21, 2014