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

• Status: Completed
• Trial end date: 2021-05-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intech Biopharm Ltd.
• Collaborators: Bao Gang Hospital; Beijing Aicomer Pharmaceutical Technology Co., Ltd.; Beijing Friendship Hospital; Beijing Yi Hua Hospital Management Co., Ltd; Daqing Oil Field Hospital; First Affiliated Hospital of Jinan University; GCP ClinPlus Co., Ltd.; Healthcare Inc; Jining Medical University; Key Tech; Meiheko Central Hospital; Meizhou People's Hospital; Peking University People's Hospital; Qingdao Municipal Hospital; Shaanxi Provincial People's Hospital; The Affiliated Hospital of Inner Mongolia Medical University; The First Affiliated Hospital of Shanxi Medical University; The Second Hospital of Hebei Medical University; Tianjin First Central Hospital
• Treatments: Budesonide

Criteria

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