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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00941577 |
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Date of registration:
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15/07/2009 |
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Primary sponsor: |
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Public title:
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Study Evaluating the Effects of AIR645 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma
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Scientific title:
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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 |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00941577 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Mike Hodges, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Altair Therapeutics, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Drug: AIR645
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Drug: Physiologic saline solution
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Primary Outcome(s)
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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]
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Secondary ID(s)
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AIR645-CS2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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