Status:
COMPLETED
Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
16-65 years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler® 160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on top of Symbicort®...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures
- A minimum of 6 months documented history of asthma according to the JGL2006/GINA2006 definition
- FEV1\> 70% of predicted normal value pre-bronchodilator
Exclusion
- Having a known or suspected allergy to study therapy (active drugs or additive)
- Having a known clinical history of hypertension, relevant arrhythmias or other heart disease, eg, ischemic heart disease, cardiomyopathy, valvular heart disease, or heart failure
- Having been treated with oral, parenteral or rectal glucocorticoids within 4 weeks, or with depot parenteral glucocorticoids within 3 months
- Respiratory infection significantly affecting the asthma, as judged by the investigator within 4 weeks
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00837967
Start Date
January 1 2009
End Date
July 1 2009
Last Update
August 29 2012
Active Locations (2)
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1
Research Site
Ibaraki, Japan
2
Research Site
Tokyo, Japan