A single-dose study to investigate the effects of 4 different doses of inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) patients
Study identifier:D1883C00007
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A randomised, double-blind placebo- and active-controlled, multi-centre, 6-way cross-over, single-dose phase IIa study to investigate the bronchodilatory and systemic effects of 4 different doses of inhaled AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD)
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD8683, Placebo, Tiotropium
Sex
All
Actual Enrollment
3
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Oct 2012
Primary Completion Date: 01 Dec 2012
Study Completion Date: 01 Dec 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Single dose of AZD8683 50 µg | Drug: AZD8683 AZD8683 administered via inhalation |
| Experimental: 2 Single dose of AZD8683 150 µg | Drug: AZD8683 AZD8683 administered via inhalation |
| Experimental: 3 Single dose of AZD8683 300 µg | Drug: AZD8683 AZD8683 administered via inhalation |
| Experimental: 4 Single dose of AZD8683 900 µg | Drug: AZD8683 AZD8683 administered via inhalation |
| Placebo Comparator: 5 Single dose of placebo | Drug: Placebo Placebo administered via inhalation |
| Active Comparator: 6 Single dose of tiotropium 18 µg | Drug: Tiotropium Tiotropium administered via inhalation |
Contacts
Investigators
Principal Investigator
Carin Jorup
AstraZeneca R&DMolndal, Sweden
