Cliantha Research
Mississauga, Ontario, L4W 1A4, Canada
NCT Number: NCT04728711
A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of ADX-629 in Subjects with Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Mississauga, Ontario, L4W 1A4, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ADX-629, 600 mg administered orally twice daily (PO bid) for a minimum of 1 week
Placebo, 600 mg administered orally twice daily (PO bid) for minimum 1 week
Time frame: The safety assessment period was Day 1 - Day 7 for each treatment intervention.
Safety was assessed through serious adverse event collection.
Time frame: The efficacy assessment period was Day 1 through Day 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization.
Change from baseline in the asthma control questionnaire, which is seven questions on a seven-point scale (0 = totally controlled, 6 = extremely poorly controlled). The first six questions are answered by the subject. The seventh question, concerning forced expiratory volume in 1 second (FEV1) percentage predicted (0 = >95% predicted, 6 = <50% predicted), is completed by clinic staff. The asthma control questionnaire is calculated as the mean of the response to all seven questions, with a higher score being more severe.
Time frame: The efficacy assessment period was Day 1 through 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization.
Change from baseline in sputum eosinophils percentage of total leukocytes at seven hours post bronchial allergen challenge and 24 hours post bronchial allergen challenge. A reduction in sputum eosinophils percentage demonstrates improvement.
Time frame: The efficacy assessment period was Day 1 through Day 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization.
Change from baseline in sputum neutrophils percentage of total leukocytes at 7 hours post bronchial allergen challenge and 24 hours post bronchial allergen challenge. A reduction in sputum neutrophils percentage demonstrates improvement.
Aldeyra Therapeutics, Inc.
Industry
A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of ADX-629 in Subjects With Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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