Status:
COMPLETED
Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to confirm the efficacy (superiority) of Symbicort® Turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg twice daily + T...
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. The dose of IGCS must be 400 to 800 µg/day of Pulmicort® Turbuhaler® or corresponding dose of IGCS. The prescribed dose of IGCS should be constant for at least 4 weeks prior to Visit 1
- Prescribed daily use of sustained release theophylline for at least 8 weeks prior to Visit 1, or confirmed steady-state blood theophylline concentrations within the effective range (5-15 µg/mL) during 8 weeks prior to Visit 1. The prescribed dose of theophylline should be constant (400 mg/day) for at least 4 weeks prior to Visit 1
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
- Additional inclusion and exclusion criteria will be evaluated by the Investigator
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00252785
Start Date
October 1 2005
End Date
November 1 2006
Last Update
January 24 2011
Active Locations (43)
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1
Research Site
Komaki, Aichi-ken, Japan
2
Research Site
Seto, Aichi-ken, Japan
3
Research Site
Asahi, Chiba, Japan
4
Research Site
Noda, Chiba, Japan