Multi-center, Single Blind, Randomized, Parallel Study to Compare the Clinical Efficacy and Safety of Dusama (Budesonide) HFA MDI With Pulmicort (Budesonide) Turbuhaler in Mild to Moderate Chinese Asthma Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 13
- 主要终点
- Change from base line of FEV1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Single blind
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Budesonide HFA MDI (Treatment A)
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
干预措施: Budesonide 200 microgram/Puff, HFA MDI (Drug)
Budesonide DPI (Turbuhaler) (Treatment B)
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
干预措施: Budesonide 100 microgram/Actuation Powder for Inhalation (Drug)
结局指标
主要结局
Change from base line of FEV1
时间窗: Week 0, 2 and 4
The change from base line of forced expiratory volume in one second after 4 weeks treatment
次要结局
- Change from base line of FEF25%(Week 0 and 4)
- Percentage of days without symptom(during week 0 to 4)
- Mean change from base line of morning and evening PEF(Week 0 and 4)
- Change from base line of FVC(Week 0 and 4)
- Subjects number with acute exacerbation(during week 0 to 4)
- Change from base line of FEV1/FVC ratio(Week 0 and 4)
- Change from base line of ACT(Week 0, 2 and 4)
- Daily PEF variability(during week 0 to 4)
- Weekly PEF variability(during week 0 to 4)
- Change from base line of FEF50%(Week 0 and 4)
- Change from base line of FEF75%(Week 0 and 4)
- Changes of day time and night time symptom(during week 0 to 4)
- Total amount of rescue medication, Ventolin 100 mcg inhaler, used(during week 0 to 4)
- Percentage of days without using rescue medicine(during week 0 to 4)