The study will assess the safety, tolerability and clinical activity of ASM-024 in subjects with mild allergic asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Mc Master University Health Sciences Center
Hamilton, Quebec, Canada
Centre de Recherche - Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada
University of Saskatechewan
Saskatoon, Saskatchewan, Canada
Late asthmatic response (LAR)
LAR as measured by the peak drop in FEV1 from 3 to 7 hours post-allergen challenge
Time frame: Day 8 of each treatment period
Early asthmatic response (EAR)
EAR as measured by the peak drop in FEV1 from 0 to 3 hours post-allergen challenge
Time frame: Day 8 of every treatment period
Airway hyperresponsiveness
Difference between methacholine PC20 measured 24 hours following allergen challenge and methacholine PC20 measured 24 hours before allergen challenge
Time frame: Days -1, 7 and 9 of each treatment period
Safety and tolerability
Time frame: Physical examination: Day 9, vital signs: Days -1, 1, 7, 8 and 9; twelve-lead ECG: Days 1, 7, 8 and 9 , AEs throughout the study, safety laboratory assessments Day 1 and 9 and Chest X-Ray: Day 9 of the final treatment period
LAR's FEV1 AUC
From 3 to 7 hours post-allergen challenge
Time frame: Day 8 of every treatment period
FEV1
24 hours post-allergen challenge
Time frame: Day 9
EAR's FEV1 AUC
From 0 to 3 hours post-allergen challenge
Time frame: Day 8
Change in FEV1
Before inhalation of ASM-024 and as soon as possible following inhalation of ASM-024
Time frame: Days 1, 7, 8 and 9
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Induced sputum eosinophil count and eosinophil and neutrophil percentages
Time frame: Days -1, 7 and 9 of every Treatment Period
Blood eosinophil count
Time frame: Days -1 and 9 of every Treatment Period
Total and differential WBC count
Time frame: Days -1 and 9 of every Treatment Period