Single-dose crossover study to investigate pharmacodynamics of AZD3199
Study identifier:D0570C00007
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A phase II, double-blind, placebo-controlled, randomised, 6-way cross-over, single-dose study to investigate the local and systemic effects of 3 doses of inhaled AZD3199 (a β2-agonist) compared to formoterol in asthmatic patients
Medical condition
asthma
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD3199, Formoterol, Placebo
Sex
All
Actual Enrollment
37
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Aug 2008
Primary Completion Date: 01 Dec 2008
Study Completion Date: 01 Dec 2008
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: crossover dose 1 AZD3199 120 microgram | Drug: AZD3199 Dry powder for inhalation, single dose |
| Experimental: crossover dose 2 AZD3199 480 microgram | Drug: AZD3199 Dry powder for inhalation, single dose |
| Experimental: crossover dose 3 AZD3199 1920 microgram | Drug: AZD3199 Dry powder for inhalation, single dose |
| Placebo Comparator: crossover dose 4 Placebo | Drug: Placebo Dry powder for inhalation, single dose |
| Active Comparator: crossover dose 5 Formoterol 9 microgram | Drug: Formoterol Dry powder for inhalation, single dose Other Name: Oxis |
| Active Comparator: crossover dose 6 Formoterol 36 microgram | Drug: Formoterol Dry powder for inhalation, single dose Other Name: Oxis |
Contacts
Investigators
Principal Investigator
Prof Leif Bjermer
University Hospital in Lund, Sweden
