A single-dose study to investigate the effects of 3 different doses of inhaled AZD2115 in COPD patients
Study identifier:D3060C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A randomised, double-blind, placebo and active controlled, multi-centre, 6 way cross-over, single-dose Phase IIa study to investigate the local and systemic effects of 3 different doses of inhaled AZD2115 in patients with chronic obstructive pulmonary disease (COPD)
Medical condition
COPD
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD2115, Placebo, Indacaterol, Indacaterol + Tiotropium
Sex
All
Actual Enrollment
39
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Mar 2012
Primary Completion Date: 01 Oct 2012
Study Completion Date: 01 Oct 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2012 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single dose of AZD2115 25 µg | Drug: AZD2115 AZD2115 administered via inhalation |
| Experimental: Single dose of AZD2115 80 µg | Drug: AZD2115 AZD2115 administered via inhalation |
| Experimental: Single dose of AZD2115 240 µg | Drug: AZD2115 AZD2115 administered via inhalation |
| Placebo Comparator: Single doses of placebo | Drug: Placebo Placebo administered via inhalation |
| Active Comparator: Single dose of indacaterol 150 µg | Drug: Indacaterol Indacaterol administered via inhalation |
| Active Comparator: Single dose of indacaterol 150 µg + tiotropium 18 µg | Drug: Indacaterol + Tiotropium Indacaterol + Tiotropium administered inhalation |
Contacts
Investigators
Principal Investigator
Carin Jorup
AstraZeneca R&D Molndal, Sweden
