Evaluation of the pharmacokinetics and the pharmacodynamics of different dry powder inhalation formulations of AZD3199 in patients with Asthma
Study identifier:D0570C00011
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2011-000133-37
CTIS identifier:N/A
Study Complete
Official Title
A Randomised, Double-blind, Double-dummy, Placebo-controlled, Multicentre, 6-way Crossover, Single-dose, Phase IIa Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 Administered via Single Inhalation Device Compared to AZD3199 Administered via Turbuhaler™ Inhaler in Patients With Asthma
Medical condition
asthma
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD3199
Sex
All
Actual Enrollment
39
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 May 2011
Primary Completion Date: 01 Feb 2012
Study Completion Date: 01 Feb 2012
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD3199 800 µg inhaled via single inhaler device (SID), single dose | Drug: AZD3199 Inhaled via single inhaler device (SID) |
| Experimental: 2 AZD3199 880 µg inhaled via SID, single dose | Drug: AZD3199 Inhaled via single inhaler device (SID) |
| Experimental: 3 AZD3199 1400 µg inhaled via SID, single dose | Drug: AZD3199 Inhaled via single inhaler device (SID) |
| Experimental: 4 AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose | Drug: AZD3199 Inhaled via Turbuhaler inhaler |
| Experimental: 5 AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose | Drug: AZD3199 Inhaled via Turbuhaler inhaler |
| Placebo Comparator: 6 Placebo inhaled via Turbuhaler inhaler and SID, single dose | Other: AZD3199 Placebo Inhaled via Turbuhaler inhaler and SID |
