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Trial record 2 of 6 for:    altair therapeutics

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00941577
Recruitment Status : Completed
First Posted : July 17, 2009
Last Update Posted : July 23, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: AIR645 Drug: Physiologic saline solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00941577

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

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Responsible Party: Mike Hodges, MD - Chief Medical Officer, Altair Therapeutics Inc. Identifier: NCT00941577     History of Changes
Other Study ID Numbers: AIR645-CS2
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: July 23, 2010
Last Verified: July 2010

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

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