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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide 200 microgram/Puff, HFA MDI
* Drug: Budesonide 100 microgram/Actuation Powder for Inhalation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide HFA MDI (Treatment A)<br>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 | Drug: Budesonide 200 microgram/Puff, HFA MDI<br>* 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.<br>* Other names: Duasma 200 mcg inhaler;|
| Active Comparator: Budesonide DPI (Turbuhaler) (Treatment B)<br>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 | Drug: Budesonide 100 microgram/Actuation Powder for Inhalation<br>* 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.<br>* Other names: Pulmicort 100 mcg Turbuhaler;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from base line of FEV1 | The change from base line of forced expiratory volume in one second after 4 weeks treatment | Week 0, 2 and 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from base line of morning and evening PEF | The mean change from base line of morning and evening PEF (peak expiratory flow) | Week 0 and 4 | 
| Change from base line of FVC | The changes from base line of FVC after 4 weeks treatment | Week 0 and 4 | 
| Change from base line of FEV1/FVC ratio | The changes from base line of FEV1/FVC ratio after 4 weeks treatment | Week 0 and 4 | 
| Change from base line of FEF25% | The changes from base line of FEF25% after 4 weeks treatment | Week 0 and 4 | 
| Change from base line of FEF50% | The changes from base line of FEF50% after 4 weeks treatment | Week 0 and 4 | 
| Change from base line of FEF75% | The changes from base line of FEF75% after 4 weeks treatment | Week 0 and 4 | 
| Change from base line of ACT | The change from base line of Asthma Control Test after 4 weeks treatment | Week 0, 2 and 4 | 
| Daily PEF variability | The Daily PEF variability (= (daily highest PEF-daily lowest PEF)X2/((daily highest PEF+daily lowest PEF) X 100% during the whole treatment period | during week 0 to 4 | 
| Weekly PEF variability | The Weekly PEF variability (= (biweely highest PEF-biweekly lowest PEF)X2/((biweekly highest PEF+biweekly lowest PEF) X 100% during the whole treatment period | during week 0 to 4 | 
| Changes of day time and night time symptom | The changes of day time and night time symptom during the treatment period | during week 0 to 4 | 
| Subjects number with acute exacerbation | The total number of subjects with acute exacerbation during treatment period | during week 0 to 4 | 
| Total amount of rescue medication, Ventolin 100 mcg inhaler, used | The total amount of doses of rescue medication, Ventolin 100 mcg inhaler, used during the treatment period | during week 0 to 4 | 
| Percentage of days without symptom | The percentage of days without asthma symptom during the treatment period | during week 0 to 4 | 
| Percentage of days without using rescue medicine | The percentage of days without using rescue medicine during the treatment period | during week 0 to 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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budesonide, MDI, DPI, China, Asthma