The study will evaluate the effect of AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD)
Study identifier:D1883C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)
Medical condition
Chronic obstructive pulmonary disease (COPD)
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD8683, 50 mcg, Placebo, AZD8683, 200 mcg
Sex
All
Actual Enrollment
28
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Oct 2010
Primary Completion Date: 01 Dec 2010
Study Completion Date: 01 Dec 2010
Study design
Allocation: Randomized
Endpoint Classification: Efficacy 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: First 50 mcg, then 200 mcg, then placebo period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo | Drug: AZD8683, 50 mcg Dry powder for inhalation, single dose Drug: Placebo Dry powder for inhalation, single dose Drug: AZD8683, 200 mcg Dry powder for inhalation, single dose |
| Experimental: First 50 mcg, then placebo, then 200 mcg period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg | Drug: AZD8683, 50 mcg Dry powder for inhalation, single dose Drug: Placebo Dry powder for inhalation, single dose Drug: AZD8683, 200 mcg Dry powder for inhalation, single dose |
| Experimental: First 200 mcg, then placebo, then 50 mcg period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg | Drug: AZD8683, 50 mcg Dry powder for inhalation, single dose Drug: Placebo Dry powder for inhalation, single dose Drug: AZD8683, 200 mcg Dry powder for inhalation, single dose |
| Experimental: First 200 mcg, then 50 mcg, then placebo period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo | Drug: AZD8683, 50 mcg Dry powder for inhalation, single dose Drug: Placebo Dry powder for inhalation, single dose Drug: AZD8683, 200 mcg Dry powder for inhalation, single dose |
| Experimental: First placebo, then 200 mcg, then 50 mcg period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg | Drug: AZD8683, 50 mcg Dry powder for inhalation, single dose Drug: Placebo Dry powder for inhalation, single dose Drug: AZD8683, 200 mcg Dry powder for inhalation, single dose |
| Experimental: First placebo, then 50 mcg, then 200 mcg period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg | Drug: AZD8683, 50 mcg Dry powder for inhalation, single dose Drug: Placebo Dry powder for inhalation, single dose Drug: AZD8683, 200 mcg Dry powder for inhalation, single dose |
Contacts
Investigators
Principal Investigator
Piotr Kuna
Poland
