The tolerability and effects of AZD8848 in allergic asthma subjects challenged with inhaled allergen
Study identifier:D0540C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A double-blind, placebo-controlled, randomised, parallel group, phase IIa study to investigate the efficacy, tolerability and safety of 8 doses of AZD8848 administered intranasally once weekly in mild to moderate allergic asthma subjects challenged with an inhaled allergen.
Medical condition
Allergic Asthma
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD8848, Placebo
Sex
All
Actual Enrollment
60
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Oct 2009
Primary Completion Date: 01 Feb 2011
Study Completion Date: 01 Dec 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2016 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD8848 (30 μg PILOT part and 60 μg MAIN part) | Drug: AZD8848 Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total. |
| Placebo Comparator: 2 Placebo | Drug: Placebo Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total. |
Contacts
Investigators
Principal Investigator
Leif Eriksson
AstraZeneca R&D Lund
