The primary objective of this study is to compare the efficacy and safety of budesonide HFA MDI 200 mcg 2 puffs BID versus budesonide DPI (Turbuhaler) 100 mcg 4 puffs BID in Chinese mild to moderate Asthma patients.
A total of 270 Chinese mild to moderate Asthma patients will be enrolled and 230 will be completed in this multi-center, randomized, single blind, parallel efficacy and safety comparison study of budesonide HFA MDI 200 mcg 2 puffs BID versus budesonide DPI (Turbuhaler) 100 mcg 4 puffs BID.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
270
Participants will inhaled 2 puffs of budesonide 200 mcg HFA MDI bid (am 08:00 and pm 16:00) for 4 weeks, if necessary rescue Ventolin (Salbutamol Sulfate) 100 mcg 2 puffs could be used with maximum daily dose of 8 puffs.
Participants will inhaled 4 puffs of budesonide 100 mcg DPI bid (am 08:00 and pm 16:00) for 4 weeks, if necessary rescue Ventolin (Salbutamol Sulfate) 100 mcg 2 puffs could be used with maximum daily dose of 8 puffs.
Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Change from base line of FEV1
The change from base line of forced expiratory volume in one second after 4 weeks treatment
Time frame: Week 0, 2 and 4
Mean change from base line of morning and evening PEF
The mean change from base line of morning and evening PEF (peak expiratory flow)
Time frame: Week 0 and 4
Change from base line of FVC
The changes from base line of FVC after 4 weeks treatment
Time frame: Week 0 and 4
Change from base line of FEV1/FVC ratio
The changes from base line of FEV1/FVC ratio after 4 weeks treatment
Time frame: Week 0 and 4
Change from base line of FEF25%
The changes from base line of FEF25% after 4 weeks treatment
Time frame: Week 0 and 4
Change from base line of FEF50%
The changes from base line of FEF50% after 4 weeks treatment
Time frame: Week 0 and 4
Change from base line of FEF75%
The changes from base line of FEF75% after 4 weeks treatment
Time frame: Week 0 and 4
Change from base line of ACT
The change from base line of Asthma Control Test after 4 weeks treatment
Time frame: Week 0, 2 and 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Daqing Oil Field Hospital
Daqing, Heilongjiang, China
Bao Gang Hospital
Baotou, Inner Mongolia, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Meiheko Central Hospital
Tonghua, Jilin, China
Affiliated Hospital of Jining Medical University
Jining, Shandon, China
QingDao Municipal Hospital
Qingdao, Shandon, China
...and 3 more locations
Daily PEF variability
The Daily PEF variability (= (daily highest PEF-daily lowest PEF)X2/((daily highest PEF+daily lowest PEF) X 100% during the whole treatment period
Time frame: during week 0 to 4
Weekly PEF variability
The Weekly PEF variability (= (biweely highest PEF-biweekly lowest PEF)X2/((biweekly highest PEF+biweekly lowest PEF) X 100% during the whole treatment period
Time frame: during week 0 to 4
Changes of day time and night time symptom
The changes of day time and night time symptom during the treatment period
Time frame: during week 0 to 4
Subjects number with acute exacerbation
The total number of subjects with acute exacerbation during treatment period
Time frame: during week 0 to 4
Total amount of rescue medication, Ventolin 100 mcg inhaler, used
The total amount of doses of rescue medication, Ventolin 100 mcg inhaler, used during the treatment period
Time frame: during week 0 to 4
Percentage of days without symptom
The percentage of days without asthma symptom during the treatment period
Time frame: during week 0 to 4
Percentage of days without using rescue medicine
The percentage of days without using rescue medicine during the treatment period
Time frame: during week 0 to 4