Status:
COMPLETED
Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to show similarity of efficacy on Pulmicort Respules 1.0 mg/day or 2.0 mg/day for 6 weeks in the treatment period and the corresponding doses of Pulmicort Turbuha...
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 JGL 2006 definition
- Asthma patients under prescribed treatment with ICS at least 3 months before Visit 2.
Exclusion
- Current or previous tobacco smokers with a history of \>= 10 pack-years
- Use of β-blockers including eye drops
- Clinically significant respiratory infection affecting the asthma, as judged by the investigator(s) within 4 weeks prior to visit 2
- Intake of oral, rectal or parenteral GCS within 4 weeks prior to Visit 2
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00855959
Start Date
February 1 2009
End Date
August 1 2009
Last Update
March 11 2011
Active Locations (6)
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1
Research Site
Ichikawa, Chiba, Japan
2
Research Site
Yokosuka, Kanagawa, Japan
3
Research Site
Chiyoda City, Tokyo, Japan
4
Research City
Hino, Tokyo, Japan