Clinical Equivalence of Budesonide HFA MDI Versus Budesonide Turbuhaler in Mild to Moderate Chinese Asthma Patients

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

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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