Asthma
Conditions
Keywords
budesonide, MDI, DPI, China, Asthma
Brief 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.
Detailed 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.
Interventions
DRUGBudesonide 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.
DRUGBudesonide 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.
Sponsors
GCP ClinPlus Co., Ltd.
Beijing Aicomer Pharmaceutical Technology Co., Ltd.
Key Tech
Healthcare Inc
Peking University People's Hospital
Beijing Friendship Hospital
Tianjin First Central Hospital
Bao Gang Hospital
The Affiliated Hospital of Inner Mongolia Medical University
Beijing Yi Hua Hospital Management Co., Ltd
The Second Hospital of Hebei Medical University
The First Affiliated Hospital of Shanxi Medical University
Shaanxi Provincial People's Hospital
Jining Medical University
Qingdao Municipal Hospital
Daqing Oil Field Hospital
First Affiliated Hospital of Jinan University
Meizhou People's Hospital
Meiheko Central Hospital
Intech Biopharm Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Single blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from base line of FEV1 | Week 0, 2 and 4 | The change from base line of forced expiratory volume in one second after 4 weeks treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from base line of FVC | Week 0 and 4 | The changes from base line of FVC after 4 weeks treatment |
| Change from base line of FEV1/FVC ratio | Week 0 and 4 | The changes from base line of FEV1/FVC ratio after 4 weeks treatment |
| Change from base line of FEF25% | Week 0 and 4 | The changes from base line of FEF25% after 4 weeks treatment |
| Change from base line of FEF50% | Week 0 and 4 | The changes from base line of FEF50% after 4 weeks treatment |
| Change from base line of FEF75% | Week 0 and 4 | The changes from base line of FEF75% after 4 weeks treatment |
| Change from base line of ACT | Week 0, 2 and 4 | The change from base line of Asthma Control Test after 4 weeks treatment |
| Mean change from base line of morning and evening PEF | Week 0 and 4 | The mean change from base line of morning and evening PEF (peak expiratory flow) |
| Weekly PEF variability | during week 0 to 4 | The Weekly PEF variability (= (biweely highest PEF-biweekly lowest PEF)X2/((biweekly highest PEF+biweekly lowest PEF) X 100% during the whole treatment period |
| Changes of day time and night time symptom | during week 0 to 4 | The changes of day time and night time symptom during the treatment period |
| Subjects number with acute exacerbation | during week 0 to 4 | The total number of subjects with acute exacerbation during treatment period |
| Total amount of rescue medication, Ventolin 100 mcg inhaler, used | during week 0 to 4 | The total amount of doses of rescue medication, Ventolin 100 mcg inhaler, used during the treatment period |
| Percentage of days without symptom | during week 0 to 4 | The percentage of days without asthma symptom during the treatment period |
| Percentage of days without using rescue medicine | during week 0 to 4 | The percentage of days without using rescue medicine during the treatment period |
| Daily PEF variability | during week 0 to 4 | The Daily PEF variability (= (daily highest PEF-daily lowest PEF)X2/((daily highest PEF+daily lowest PEF) X 100% during the whole treatment period |
Countries
China
Outcome results
None listed