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

Sponsor:	Altair Therapeutics, Inc.
Information provided by:	Altair Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00941577

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:

MedlinePlus related topics: Allergy Asthma Bronchial Disorders

U.S. FDA Resources

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

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 May 23, 2012