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

Intech Biopharm

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Budesonide 200 microgram/Puff, HFA MDI; Drug: Budesonide 100 microgram/Actuation Powder for Inhalation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05152355

INTB011H01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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270 participants in 2 patient groups

Budesonide HFA MDI (Treatment A)

Experimental group

Description:

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

Treatment:

Drug: Budesonide 200 microgram/Puff, HFA MDI

Budesonide DPI (Turbuhaler) (Treatment B)

Active Comparator group

Description:

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

Treatment:

Drug: Budesonide 100 microgram/Actuation Powder for Inhalation