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 + Theolong® tablet 200 mg twice daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
340
Morning peak expiratory flow (mPEF)
Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries
Forced expiratory volume in one second (FEV1)
Safety:
Adverse events (nature, incidence and severity)
Haematology, clinical chemistry and urinalysis
12-lead ECGs, blood pressure, pulse rate
- all variables assessed over the 8 week treatment period
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Research Site
Komaki, Aichi-ken, Japan
Research Site
Seto, Aichi-ken, Japan
Research Site
Asahi, Chiba, Japan
Research Site
Noda, Chiba, Japan
Research Site
Touon, Ehime, Japan
Research Site
Miyaodai, Fukuoka, Japan
Research Site
Gifu, Gifu, Japan
Research Site
Isesaki, Gunma, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Ōta, Gunma, Japan
...and 33 more locations