Bronchial asthma
Conditions
Interventions
Budesonide Aerosol Inhaler Group:Inhale 200 µg of Budesonide Aerosol Inhaler (Baoyisu) twice daily for 4 weeks.
Budesonide Dry Powder Inhaler Group:Inhaled budesonide inhalation powder spray every morning and evening (1 inhalation per day, 200 µg/inhalation, 2 times a day, a total of 400 µg, for 4 weeks.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The subject fully understands the purpose, nature and method of the trial, voluntarily acts as a subject, and signs the informed consent form before the start of any research procedures; 2. Adults (including males, non-pregnant, and non-lactating females) (18~70 years old, including boundary values), according to the latest domestic guidelines for the prevention and treatment of bronchial asthma, bronchial asthma patients who are diagnosed with mild and non-acute attacks for the first time need to receive glucocorticoid therapy; 3. Objective examination that satisfies any of the following variable airflow limitations: positive bronchodilator test (FEV1 increases by >12% after inhalation of bronchodilator (SABA 400 µg), and the absolute value of FEV1 increases by >200 mL); positive bronchial provocation test; The inhaled stimulant is usually acemethacholine or histamine, usually with a 20=% decrease in FEV1 after inhalation of the stimulant, and the result is positive, indicating the presence of airway hyperresponsiveness; Average daily diurnal variability rate of peak expiratory flow (PEF) (sum of daily PEF diurnal variability rates for at least 7 consecutive days/total number of days 7) >10%, or PEF weekly variability rate {(highest PEF value in 2 weeks - lowest PEF value)/[(highest PEF value in 2 weeks + minimum PEF) ×1/2]× 100%}>20%; 4. At the time of screening, the pulmonary function test FEV1 accounted for 80%~110% of the predicted value; 5. The subject or his guardian can communicate well with the investigator, and understand and comply with this study The requirements of the research.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic or intolerant to budesonide or albuterol or any drug components; 2. Respiratory tract infectious diseases within 2 months before screening; 3. Those who have a history of chronic obstructive pulmonary disease, interstitial lung disease, restrictive lung disease, tuberculosis, cystic fibrosis, bronchiectasis or a1-antitrypsin deficiency at the time of screening; 4. Have a major illness at screening, such as: congestive heart failure, uncontrolled hypertension, severe coronary artery disease, myocardial infarction, or severe cardiac arrhythmia or have a history of significant hematologic, hepatic, neurological, musculoskeletal, endocrine, metabolic, psychiatric, nephropathy, or other medical conditions at screening. If the above diseases worsen during the study, they may put the patient at risk by participating in the study, or affect the results of the study; 5. Those who have had more than 8 times of oral inhalation of short-acting inhale bete 2-agonist (SABA) in 1 day during the screening period; 6. Those who are using ß receptor blocker therapy (including eye drops), systemic hormone therapy, leukotriene receptor antagonists (such as zafirlukast, prolukast, montelukast, etc.) or CYP3A4 inhibitors (ketoconazole, itraconazole), cimetidine, disulfiram, metronidazole, etc., or CYP3A4 enzyme strong inducers (such as rifampicin, carbamazepine, phenytoin, etc.) and other concomitant drugs prohibited by this study and are unwilling to stop during the trial; 7. Those who have smoked in the past and have a smoking index > 10 packs-year [smoking index (packs) = daily smoking volume (packs) × smoking time (years), 1 pack = 20 cigarettes]; 8. Those who have quit smoking for = 6 months or are current smokers at the time of screening; 9. Known or suspected alcohol and/or drug abuse, alcoholism, i.e., drinking more than 2 units of alcohol per day on average (1 unit = 360mL of beer or 45mL of liquor or 150mL of wine with 40% alcohol); 10. Diabetic patients with poor control or fasting blood glucose > 10mmol/L at screening; 11. Patients with obvious abnormal liver and kidney function at screening: liver function (ALT, AST) exceeds 2 times the upper limit of normal, or renal function (Cr) exceeds 1.5 times of the upper limit of normal; 12. Female subjects with a positive pregnancy test or who are lactating, as well as male subjects (or their partners) or female subjects who are unable to use effective contraception or have a family plan throughout the trial period and within 6 months after the end of the study; 13. Those who have participated in other medical device clinical trials within 1 month before screening and/or other drug clinical trials within 3 months before screening; 14. Patients who cannot comply with the study procedures or are judged by the investigator to be unsuitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Forced Expiratory Volume in 1 second (FEV1) from baseline after 4 weeks of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Asthma Control Test (ACT) score from baseline after 4 weeks of treatment.;PEF weekly variability during treatment.;Change in lung function tests (FVC, FEV1/FVC, and FEF 25%-75%) from baseline after 4 weeks of treatment.;Average daytime and nighttime asthma symptom scores after 4 weeks of treatment.;Number of subjects with acute bronchial asthma exacerbations.;Use of rescue medications.;Number of days with controlled asthma symptoms.;Vital signs (temperature, pulse, respiration, blood pressure).;Laboratory tests: Complete blood count (CBC), blood chemistry, urinalysis.;12-lead electrocardiogram (ECG).; | — |
Countries
China
Contacts
Public ContactZhang Min
Shanghai First People's Hospital (Department of Respiratory and Critical Care Medicine)
Outcome results
None listed