Status:
COMPLETED
Safety & Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
This study is to confirm the safety of Symbicort® Turbuhaler® 160/4.5 µg 1, 2 or 4 inhalation b.i.d. over a 52 week treatment period in asthmatic patients who are being treated with IGCS and long acti...
Eligibility Criteria
Inclusion
- Diagnosis of asthma with a documented history of at least 6 months duration prior to Visit 1
- Prescribed daily use of an IGCS for ≥12 weeks prior to Visit 1
- Prescribed daily use of at least one of the following:
- Theophylline, long acting β2-agonist (LABA), other anti-asthmatic drugs (leucotrine antagonists, inhaled anti-cholinergics, Th2 cytokine inhibitor) for at least 4 weeks prior to Visit 1 at a constant dose
Exclusion
- Any significant disease or disorder that may jeopardize the safety of the patient
- Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1
- Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00255255
Start Date
November 1 2005
End Date
June 1 2007
Last Update
January 24 2011
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Komaki, Aichi-ken, Japan
2
Research Site
Seto, Aichi-ken, Japan
3
Research Site
Gifu, Gifu, Japan
4
Research Site
Ōwa, Gunma, Japan