Trial | NCT05152355  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    270
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.
Study Started
Apr 22
2019
Primary Completion
May 09
2021
Study Completion
May 09
2021
Last Update
Dec 09
2021

Drug Budesonide 200 microgram/Puff, HFA MDI

Participants will inhaled 2 puffs of budesonide 200 mcg HFA MDI bid (am 08:00 and pm 16:00) for 4 weeks, if necessary rescue Ventolin (Salbutamol Sulfate) 100 mcg 2 puffs could be used with maximum daily dose of 8 puffs.

  • Other names: Duasma 200 mcg inhaler

Drug Budesonide 100 microgram/Actuation Powder for Inhalation

Participants will inhaled 4 puffs of budesonide 100 mcg DPI bid (am 08:00 and pm 16:00) for 4 weeks, if necessary rescue Ventolin (Salbutamol Sulfate) 100 mcg 2 puffs could be used with maximum daily dose of 8 puffs.

  • Other names: Pulmicort 100 mcg Turbuhaler

Budesonide HFA MDI (Treatment A) Experimental

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) Active Comparator

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

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
No Results Posted