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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01225549
First received: October 15, 2010
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Asthma
 Drug: AZD5423
Drug: Budesonide 200 microgram
Drug: Placebo
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Late Asthmatic response measured by forced expiratory volume in 1 second (FEV1) maximum fall in %. [ Time Frame: Repeated assessments pre (within 1 h) and 3 to 7 h after allergen challenge. Allergen Challenge will be performed at screening and on day 6 of treatment in each treatment period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Early Asthmatic response measured by forced expiratory volume in 1 second (FEV1) maximum fall in %. [ Time Frame: Repeated assessments pre (within 1 h) and up to 3 h after allergen challenge. Allergen Challenge will be performed at screening and on day 6 of treatment in each treatment period. ] [ Designated as safety issue: No ]
  • AUC based EAR(0-3h) [ Time Frame: Repeated assessments pre (within 1 h) and up to 3 h after allergen challenge. Allergen Challenge will be performed at screening and on day 6 of treatment in each treatment period. ] [ Designated as safety issue: No ]
  • AUC based LAR (3-7h) [ Time Frame: Repeated assessments pre (within 1 h) and 3 to 7 h after allergen challenge. Allergen Challenge will be performed at screening and on day 6 of treatment in each treatment period. ] [ Designated as safety issue: No ]
  • Airway hyperresponsiveness to methacholine, PC20 [ Time Frame: 24h pre and 24 h after allergen challenge. Allergen Challenge will be performed at screening and on day 6 of treatment in each treatment period. ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD5423 75ug
 Drug: AZD5423
Suspension for nebulisation once daily 7 days
Drug: Placebo
Dry powder for inhalation twice daily 7 days
Experimental: 2
AZD5423 300ug
 Drug: AZD5423
Suspension for nebulisation once daily 7 days
Drug: Placebo
Dry powder for inhalation twice daily 7 days
Active Comparator: 3
Budesonide 200 microgram
 Drug: Budesonide 200 microgram
Dry powder for inhalation twice daily 7 days
Other Name: Pulmicort
Drug: Placebo
Solution for nebulisation once daily 7 days
Placebo Comparator: 4
Placebo
 Drug: Placebo
Solution for nebulisation once daily 7 days
Drug: Placebo
Dry powder for inhalation twice daily 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225549

Locations
Canada, Alberta
Research Site
Calgary, Alberta, Canada
Canada, Ontario
Research Site
Hamilton, Ontario, Canada
Canada, Saskatchewan
Research Site
Saskatoon, Saskatchewan, Canada
Canada
Research Site
Quebec, Canada
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Christer Hultquist AstraZeneca R&D Mölndal, Sweden
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01225549     History of Changes
Other Study ID Numbers: D2340C00005
Study First Received: October 15, 2010
Last Updated: April 12, 2012
Health Authority: Canada: Health Canada

Keywords provided by AstraZeneca:
Allergen Challenge
Asthma
Inhaled selective glucocorticoid receptor agonist (iSEGRA)

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 13, 2013