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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
AZD5423
Budesonide 200 microgram
Placebo
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Allergen Challenge, Asthma, Inhaled selective glucocorticoid receptor agonist (iSEGRA)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

AZD5423 75ug

AZD5423 300ug

Budesonide 200 microgram

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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)
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)
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)
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)
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)
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)

Full Information

First Posted
October 15, 2010
Last Updated
March 31, 2015
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01225549
Brief Title
The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled Allergen
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Allergen Challenge, Asthma, Inhaled selective glucocorticoid receptor agonist (iSEGRA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
AZD5423 75ug
Arm Title
2
Arm Type
Experimental
Arm Description
AZD5423 300ug
Arm Title
3
Arm Type
Active Comparator
Arm Description
Budesonide 200 microgram
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
AZD5423
Intervention Description
Suspension for nebulisation once daily 7 days
Intervention Type
Drug
Intervention Name(s)
Budesonide 200 microgram
Other Intervention Name(s)
Pulmicort
Intervention Description
Dry powder for inhalation twice daily 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for nebulisation once daily 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for nebulisation once daily 7 days
Primary Outcome Measure Information:
Title
Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1
Description
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
Secondary Outcome Measure Information:
Title
Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge
Description
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
Title
Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge
Description
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
Title
Airway Hyperresponsiveness by Assessment of Methacholine PC20
Description
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)
Title
Airway Hyperresponsiveness by Assessment of Methacholine PC20
Description
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)
Title
Airway Hyperresponsiveness by Assessment of Methacholine PC20
Description
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 7 ([post-dose] 24 hours post allergen challenge)
Title
Changes in Sputum Eosinophils Differentials (Percentage)
Description
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)
Title
Changes in Sputum Eosinophils Differentials (Percentage)
Description
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)
Title
Changes in Sputum Eosinophils Differentials (Percentage)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christer Hultquist
Organizational Affiliation
AstraZeneca R&D, Mölndal, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25473939
Citation
Gauvreau GM, Boulet LP, Leigh R, Cockcroft DW, Killian KJ, Davis BE, Deschesnes F, Watson RM, Swystun V, Mardh CK, Wessman P, Jorup C, Aurivillius M, O'Byrne PM. A nonsteroidal glucocorticoid receptor agonist inhibits allergen-induced late asthmatic responses. Am J Respir Crit Care Med. 2015 Jan 15;191(2):161-7. doi: 10.1164/rccm.201404-0623OC.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=203&filename=D2340C00005.pdf
Description
CSR Synopsis

Learn more about this trial

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

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