Clinical trial NCT01225549: The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Allergen Challenge
Asthma
Inhaled selective glucocorticoid receptor agonist (iSEGRA)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1
timeFrame: From Randomization to end of treatment
Secondary outcomes:
measure: Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge
timeFrame: From Randomization to end of treatment
measure: Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge
timeFrame: From Randomization to end of treatment
measure: Airway Hyperresponsiveness by Assessment of Methacholine PC20
timeFrame: Day 1 (pre-dose)
measure: Airway Hyperresponsiveness by Assessment of Methacholine PC20
timeFrame: Day 5 ([post-dose] pre allergen challenge)
measure: Airway Hyperresponsiveness by Assessment of Methacholine PC20
timeFrame: Day 7 ([post-dose] 24 hours post allergen challenge)
measure: Changes in Sputum Eosinophils Differentials (Percentage)
timeFrame: Day 5 (post dose)
measure: Changes in Sputum Eosinophils Differentials (Percentage)
timeFrame: Day 6 ([post dose] 7 hours post allergen challenge)
measure: Changes in Sputum Eosinophils Differentials (Percentage)
timeFrame: Day 7 ([post dose] 24 hours post allergen challenge)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Christer Hultquist
role: STUDY_DIRECTOR
References:
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.