The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled Allergen

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma challenged with an inhaled allergen.

Official Title
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A Double-blind, Double-dummy, Randomised, Placebo-controlled, 4-way, Crossover, Multi-centre Phase II Study With Budesonide as an Active Control to Evaluate the Efficacy and Safety of 2 Doses of Inhaled AZD5423 Over 7 Days in Patients With Mild Allergic Asthma Challenged With an Inhaled Allergen

Conditions
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Asthma

Intervention / Treatment
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* Drug: AZD5423
* Drug: Budesonide 200 microgram
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-60 years of age Pre-bronchodilatory FEV1 ≥70% of predicted normal allergic asthmatic with a history of episodic wheeze Positive allergen induced early and late airway bronchoconstriction showing ≥ 20% fall in FEV1 for the early and ≥ 15% for the late response Positive skin prick test to common aeroallergens Exclusion Criteria: Any clinically significant disease or disorder Any clinically relevant abnormal finding at screening examinations Smoker or ex-smoker who has stopped smoking < 12 months prior to study start Worsening of asthma or respiratory infection within 6 weeks from visit 1 Allergen-specific immunotherapy within 6 months prior to visit 1

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD5423 75ug | Drug: AZD5423<br>* Suspension for nebulisation once daily 7 days<br>Drug: Placebo<br>* Solution for nebulisation once daily 7 days<br>|
| Experimental: 2<br>AZD5423 300ug | Drug: AZD5423<br>* Suspension for nebulisation once daily 7 days<br>Drug: Placebo<br>* Solution for nebulisation once daily 7 days<br>|
| Active Comparator: 3<br>Budesonide 200 microgram | Drug: Budesonide 200 microgram<br>* Dry powder for inhalation twice daily 7 days<br>* Other names: Pulmicort;Drug: Placebo<br>* Solution for nebulisation once daily 7 days<br>|
| Placebo Comparator: 4<br>Placebo | Drug: Placebo<br>* Solution for nebulisation once daily 7 days<br>Drug: Placebo<br>* Solution for nebulisation once daily 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From Randomization to end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | Day 7 ([post dose] 24 hours post allergen challenge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergen Challenge, Asthma, Inhaled selective glucocorticoid receptor agonist (iSEGRA)