Clinical Equivalence of Budesonide HFA MDI Versus Budesonide Turbuhaler in Mild to Moderate Chinese Asthma Patients
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT05152355
- Lead Sponsor
- Intech Biopharm Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- Aged 18 to 70 years old and diagnosed as Asthma in clinics
- Diagnosed as Asthma according to the 2016 Asthma guidance of Chinese Thoracic Society, and without administer corticosteroids within three months, either new or old patients
- FEV1 predicted ≧ 60%
- Patients is willing to participate the study and signed the Informed Consent Form
- Allergy to budesonide or salbutamol
- Infections of Respiratory tract, nasal-sinus and ear within 4 weeks before enrollment
- Severe nasal allergy and need the treatment of corticostreoids and histamines.
- Severe cardiovascular disease history
- Has used leukotriene receptor antagonist (Montelukast, Pranlukast, Zafirlukast etc.) within 2 weeks before enrollment
- Severe cognition or mental disorder and can not cooperation with the treatment
- Significant liver dysfunction, AST, ALT > 3 X normal upper limits, CR > 1.5 X normal upper limits
- Patients with uncontrolled diabetes or fasting blood glucose > 10 mmol/L
- Patients currently receiving beta-antagonists or beta-agonists treatment (including eye drops)
- Patients who has contraindications to beta2-agonists
- Patients who has participated others drug's clinical study within three months
- Female patients who are pregnant or lactation or prepare to pregnant
- Any conditions which the investigators considered not suitable to enrolled
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Budesonide HFA MDI (Treatment A) Budesonide 200 microgram/Puff, HFA MDI Participants assigned to Experimental arm will inhaled 2 puffs of budesonide 200 mcg HFA MDI bid (am 08:00 and pm 16:00) for 4 weeks Budesonide DPI (Turbuhaler) (Treatment B) Budesonide 100 microgram/Actuation Powder for Inhalation Participants assigned to Active Comparator arm will inhaled 4 puffs of budesonide 100 mcg powder for inhalation bid (am 08:00 and pm 16:00) for 4 weeks
- Primary Outcome Measures
Name Time Method Change from base line of FEV1 Week 0, 2 and 4 The change from base line of forced expiratory volume in one second after 4 weeks treatment
- Secondary Outcome Measures
Name Time Method Change from base line of FEF25% Week 0 and 4 The changes from base line of FEF25% after 4 weeks treatment
Percentage of days without symptom during week 0 to 4 The percentage of days without asthma symptom during the treatment period
Mean change from base line of morning and evening PEF Week 0 and 4 The mean change from base line of morning and evening PEF (peak expiratory flow)
Change from base line of FVC Week 0 and 4 The changes from base line of FVC after 4 weeks treatment
Subjects number with acute exacerbation during week 0 to 4 The total number of subjects with acute exacerbation during treatment period
Change from base line of FEV1/FVC ratio Week 0 and 4 The changes from base line of FEV1/FVC ratio after 4 weeks treatment
Change from base line of ACT Week 0, 2 and 4 The change from base line of Asthma Control Test after 4 weeks treatment
Daily PEF variability during week 0 to 4 The Daily PEF variability (= (daily highest PEF-daily lowest PEF)X2/((daily highest PEF+daily lowest PEF) X 100% during the whole treatment period
Weekly PEF variability during week 0 to 4 The Weekly PEF variability (= (biweely highest PEF-biweekly lowest PEF)X2/((biweekly highest PEF+biweekly lowest PEF) X 100% during the whole treatment period
Change from base line of FEF50% Week 0 and 4 The changes from base line of FEF50% after 4 weeks treatment
Change from base line of FEF75% Week 0 and 4 The changes from base line of FEF75% after 4 weeks treatment
Changes of day time and night time symptom during week 0 to 4 The changes of day time and night time symptom during the treatment period
Total amount of rescue medication, Ventolin 100 mcg inhaler, used during week 0 to 4 The total amount of doses of rescue medication, Ventolin 100 mcg inhaler, used during the treatment period
Percentage of days without using rescue medicine during week 0 to 4 The percentage of days without using rescue medicine during the treatment period
Trial Locations
- Locations (13)
The Second Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, He Bei Sheng, China
Bao Gang Hospital
🇨🇳Baotou, Inner Mongolia, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
The First Affiliated Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shan XI Sheng, China
Shanxi Provincial People's Hospital
🇨🇳Taiyuan, Shan XI Sheng, China
QingDao Municipal Hospital
🇨🇳Qingdao, Shandon, China
Daqing Oil Field Hospital
🇨🇳Daqing, Heilongjiang, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Guangdong, China
Meizhou People's Hospital
🇨🇳Meizhou, Guangdong, China
Meiheko Central Hospital
🇨🇳Tonghua, Jilin, China
Affiliated Hospital of Jining Medical University
🇨🇳Jining, Shandon, China
Tianjin First Central Hospital
🇨🇳Tianjin, China