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

Asthma Clinical Trial

— Allergen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225549
• Other study ID #: D2340C00005
• Status: Completed
• Phase: Phase 2
• First received: October 15, 2010
• Last updated: March 31, 2015
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• AZD5423
Suspension for nebulisation once daily 7 days
• Budesonide 200 microgram
Dry powder for inhalation twice daily 7 days
• Placebo
Solution for nebulisation once daily 7 days
• Placebo
Solution for nebulisation once daily 7 days

Locations

Country	Name	City	State
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No

External Links

•   CSR Synopsis