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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014