The study will evaluate the effect of AZD9164 in patients with Chronic Obstructive Pulmonary Disease - LaCrossE
Study identifier:D1882C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A double-blind, double-dummy, placebo-controlled, randomised, multi-centre, 5-way cross-over, single-dose study to investigate the local and systemic effects of inhaled AZD9164 compared to tiotropium in subjects with Chronic Obstructive Pulmonary Disease (COPD)
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD9164, Tiotropium, Placebo
Sex
All
Actual Enrollment
25
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Jun 2009
Primary Completion Date: 01 Nov 2009
Study Completion Date: 01 Nov 2009
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2011 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD9164 100 mcg First, then Placebo for Spririva 1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation | Drug: AZD9164 Solution for inhalation through nebulization, single dose Drug: Placebo Placebo |
| Experimental: AZD9164 400 mcg First, then Placebo for Spiriva 1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation | Drug: AZD9164 Solution for inhalation through nebulization, single dose Drug: Placebo Placebo |
| Experimental: AZD9164 1200 mcg First, then Placebo for Spiriva 1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation | Drug: AZD9164 Solution for inhalation through nebulization, single dose Drug: Placebo Placebo |
| Active Comparator: Spiriva 18 mcg First, then Placebo for AZD9164 1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride) | Drug: Tiotropium Dry powder for inhalation, single dose Other Name: Spiriva Drug: Placebo Placebo |
| Placebo Comparator: Placebo for Spiriva First, then Placebo for AZD9164 1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride) | Drug: Placebo Placebo |
Contacts
Investigators
Principal Investigator
Leif Bjermer
University Hospital in Lund, Sweden
