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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: AZD5423; Drug: Budesonide 200 microgram; Drug: Placebo

• Registration Number: NCT01225549
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-15
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-21
• Study Start: 2010-11
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2015-01-15
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-31
• Last Update Submitted: 2015-03-31
• Results First Posted: 2015-04-02
• Last Update Posted: 2015-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Placebo	AZD5423 75ug
2	AZD5423	AZD5423 300ug
3	Placebo	Budesonide 200 microgram
4	Placebo	Placebo
1	AZD5423	AZD5423 75ug
2	Placebo	AZD5423 300ug
3	Budesonide 200 microgram	Budesonide 200 microgram

Primary Outcome Measures

Name	Time	Method
Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1	From Randomization to end of treatment	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

Secondary Outcome Measures

Name	Time	Method
Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge	From Randomization to end of treatment	Minimum Percentage of FEV1 over 0 to 3 hours post allergen challenge compared to pre allergen challenge FEV1
Changes in Sputum Eosinophils Differentials (Percentage)	Day 7 ([post dose] 24 hours post allergen challenge)	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)
Airway Hyperresponsiveness by Assessment of Methacholine PC20	Day 7 ([post-dose] 24 hours post allergen challenge)	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)
Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge	From Randomization to end of treatment	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

Trial Locations

Locations (1)

Research Site; 🇨🇦 Quebec, Canada