The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma challenged with an inhaled allergen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
Research Site
Calgary, Alberta, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Saskatoon, Saskatchewan, Canada
Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1
LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1
Time frame: From Randomization to end of treatment
Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge
Minimum Percentage of FEV1 over 0 to 3 hours post allergen challenge compared to pre allergen challenge FEV1
Time frame: From Randomization to end of treatment
Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge
AUC was assessed as average percentage of FEV1 remaining 0 to 3 hours and 3 to 7 hours post allergen challenge compared to pre allergen challenge FEV1
Time frame: From Randomization to end of treatment
Airway Hyperresponsiveness by Assessment of Methacholine PC20
The methacholine challenge was performed on Day 1 (pre dose), Day 5 (\[post dose\] pre AC), and Day 7 (\[post dose\] 24 hours post AC)
Time frame: Day 1 (pre-dose)
Airway Hyperresponsiveness by Assessment of Methacholine PC20
The methacholine challenge was performed on Day 1 (pre dose), Day 5 (\[post dose\] pre AC), and Day 7 (\[post dose\] 24 hours post AC)
Time frame: Day 5 ([post-dose] pre allergen challenge)
Airway Hyperresponsiveness by Assessment of Methacholine PC20
The methacholine challenge was performed on Day 1 (pre dose), Day 5 (\[post dose\] pre AC), and Day 7 (\[post dose\] 24 hours post AC)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Solution for nebulisation once daily 7 days
Time frame: Day 7 ([post-dose] 24 hours post allergen challenge)
Changes in Sputum Eosinophils Differentials (Percentage)
The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 (\[post dose\] 7 hours post allergen challenge) and Day 7 (\[post dose\] 24 hours post allergen challenge)
Time frame: Day 5 (post dose)
Changes in Sputum Eosinophils Differentials (Percentage)
The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 (\[post dose\] 7 hours post allergen challenge) and Day 7 (\[post dose\] 24 hours post allergen challenge)
Time frame: Day 6 ([post dose] 7 hours post allergen challenge)
Changes in Sputum Eosinophils Differentials (Percentage)
The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 (\[post dose\] 7 hours post allergen challenge) and Day 7 (\[post dose\] 24 hours post allergen challenge)
Time frame: Day 7 ([post dose] 24 hours post allergen challenge)