A Phase II study to Evaluate the efficacy, safety and tolerability of AZD5069 in Patients with Uncontrolled Persistent Asthma. - NIMBUS
Study identifier:D3551C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2012-001869-33
CTIS identifier:N/A
Study Complete
Official Title
A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma
Medical condition
asthma
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD5069, Placebo
Sex
All
Actual Enrollment
1147
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 Nov 2012
Primary Completion Date: 01 Aug 2014
Study Completion Date: 01 Aug 2014
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD5069 5 mg AZD5069 oral capsules self-administered twice daily | Drug: AZD5069 AZD5069 oral capsules self-administered twice daily. |
| Experimental: AZD5069 15 mg AZD5069 oral capsules self-administered twice daily | Drug: AZD5069 AZD5069 oral capsules self-administered twice daily. |
| Experimental: AZD5069 45 mg AZD5069 oral capsules self-administered twice daily | Drug: AZD5069 AZD5069 oral capsules self-administered twice daily. |
| Placebo Comparator: Placebo Placebo oral capsules self-administered twice daily | Drug: Placebo Placebo oral capsules self-administered twice daily. |
Contacts
Investigators
Principal Investigator
Bengt Larsson
AZ Mondal R&D, Sweden
