Study to investigate the safety and efficacy of high dose of Symbicort® SMART in Japanese patients
Study identifier:D589LC00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A comparison of tolerability of 10 inhalations of Symbicort® Turbuhaler® 160/4.5 μg and 10 inhalations of terbutaline Turbuhaler® 0.4 mg on top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation bid, randomized, double-blind, cross over, phase III study in Japanese adults asthma patients
Medical condition
asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
Symbicort Turbuhaler, Terbutaline Turbuhaler
Sex
All
Actual Enrollment
25
Study type
Interventional
Age
16 Years - 65 Years
Date
Study Start Date: 01 Jan 2009
Primary Completion Date: 01 Jul 2009
Study Completion Date: 01 Jul 2009
Study design
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: First Symbicort, then Terbutaline Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days | Drug: Symbicort Turbuhaler 160/4.5μg for 3 days Drug: Terbutaline Turbuhaler 0.4 mg for 3 days |
| Experimental: First Turbuhaler, then Symbicort Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days, | Drug: Symbicort Turbuhaler 160/4.5μg for 3 days Drug: Terbutaline Turbuhaler 0.4 mg for 3 days |
Contacts
Investigators
Principal Investigator
Tomas Andersson
AstraZeneca R&D Lund
