Trial record 2 of 5 for:
altair therapeutics
Study Evaluating the Effects of AIR645 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma
This study has been completed.
Sponsor:
Altair Therapeutics, Inc.
Information provided by:
Altair Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00941577
First received: July 15, 2009
Last updated: July 21, 2010
Last verified: July 2010
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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 May 23, 2013