Adult bronchial asthma
Conditions
Interventions
experimental group:SalmexTM (fluticasone propionate 250 g, salmeterol 50 g) + sullide simulator
control group:Seretide (fluticasone propionate 250 g, SalmexTM 50 g) +SalmexTM emulator
Sponsors
The First Affiliated Hospital Of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) voluntarily enrolled, signed the informed consent file, and with the capability to complete the observation and evaluation of the experiment. 2) outpatient subjects, aged 18-70 years old, male or female. 3) according to the diagnostic criteria of "guidelines for the prevention and treatment of bronchial asthma (2016 edition)" issued by the respiratory society of the Chinese medical association, bronchial asthma is clinically diagnosed. The diagnostic criteria are shown in annex 1. 4) FEV1 before the use of bronchodilators accounted for 40%~85% of the expected value (40% = 12% and the increase of absolute value is >= 200mL. B. The average daily diurnal variation rate of peak expiratory flow (PEF)for 7 days before randomization (for 7 consecutive days, total daily diurnal PEF variation rate / 7) > 10%. Note: if there is any omission, at least 5 days' average daily diurnal PEF variation rate is required to be > 10% 6) subjects who were regularly treated with ICS or ICS/LABA in the last 4 weeks of V1 should meet the following requirements: A. ICS daily dose equivalent to beclomethasone propionate (chlorofluorocarbons) <= 1000 g after equivalent dose conversion. B. subjects using ICS/LABA in the form of monotherapy or combination therapy may not be admitted if the current ICS/LABA treatment is changed to an ICS monotherapy (the ICS dose remains unchanged) by the evaluation of investigator. 7) subjects who were treated with SABA or other symptom-relieving drugs before V1 were evaluated and considered by the inestigators to be eligible for replacement with the same type of drug (albuterol) uniformly provided in this study. At the same time, subjects should not use such drugs at least 6 hours before the lung function test. 8) before randomization, the following drugs shall meet the requirements for the corresponding interval of drug withdrawal: drug category, interval of drug withdrawal: Long-acting beta agonists (inhaled or oral), such as Salmeterol, Formoterol for 1 day, short-acting toadstool alkali resistance, such as isopropyl bromide for 12 hours, long-acting toadstool alkali resistance, such as Glycopyrrolate, thiamethoxam bromide for 7 days, theophylline, Ketotifene, Sodium cromoglicate, nedocromil sodium for 1 day,CYP450 3A4 inhibitors, such as ketoconazole , itraconazole, and Ritonavir for 4 weeks, leukotriene regulator, such as Zafirlukast, Montelukast for 2 days, the immune inhibitors, such as methotrexate, azathioprine, cyclosporine, Cyclophosphamide for six months, resistance to LgE antibody, such as omazor for 3 months. Other drugs that may affect asthma or have sympathetic effects, such as anticonvulsants, Polycyclic antidepressants, ß-receptor blocker, Phenothiazines, Monoamine oxidase inhibitor for 1 day 9) quit smoking for at least one year (including: cigarettes, cigars, pipe tobacco, e-cigarettes, etc.) at the time of visit 1, and the smoking history <= 10 packets·year [smoking index (packet year) = daily smoking volume (packet) x smoking time (year), 1 packet =20 cigarettes]. 10) the results of serum pregnancy test in the screening period of women in childbearing age were
Exclusion criteria
Exclusion criteria: 1) a fatal acute episode of bronchial asthma (requiring endotracheal intubation, hyperventilation, respiratory arrest or hypoxic convulsion, etc.) has occurred in the past 10 years. 2) respiratory tract infection leading to changes in the treatment of asthma: confirmed bacterial or viral upper respiratory tract infection, sinusitis, or otitis media within 4 weeks of V1 or the induction period, or the investigator determine that the condition of asthma will affect the subject's ability to participate in the study. 3) systemic glucocorticoid use: an acute attack of asthma requiring systemic glucocorticoid treatment occurred within 4 weeks before 1 visit or during the induction period, or oral glucocorticoid treatment was required for the asthma condition of the subjects. 4) other respiratory diseases, including but not limited to pneumonia, pneumothorax, pulmonary fibrosis, atelectasis, bronchopulmonary dysplasia, chronic bronchitis, emphysema, and chronic obstructive pulmonary disease. 5) patients with abnormal liver or kidney functions, namely, the laboratory examination indexes reach the following standards: A. Liver function: ALT > 2 * ULN and AST > 2 * ULN, or ALP > 1.5 * ULN and serum total bilirubin > 1.5 * ULN. b. renal function: serum creatinine > 1.5 * ULN and creatinine clearance rate (CrCl) or glomerular filtration rate (GFR) < 60mL/min (CockcroftGault formula). 6) combination of other clinically significant diseases or abnormal, uncontrolled conditions or diseases which will put the subjects at risk or affect the judgment of the study results as determined by the investigators. These conditions include but are not limited to cardiovascular, digestive, endocrine, immune, blood, metabolic, tumor, mental or nervous system abnormalities. 7) during the screening period, ECG was found in the condition that the researcher thought was not suitable for the test. 8) Allergy to Salmeterol or to ingredients in the research drug such as lactose; Allergy to albuterol. 9) confirmed or suspected candidiasis identified by oral examination (except for those that the investigator considers to be confirmedly excluded). 10) participated in clinical trials of other drugs within 4 weeks prior to visit 1 or remained in the 5 half-lives of the drug under study. 11) subjects who are expected to undergo surgery during the study period. 12) pregnant or lactating women. 13) a history of drug abuse or alcohol abuse within 2 years before the visit 1. alcohol abuse is defined as drinking an average of more than 2 units of alcohol per day (1 unit =360mL beer or 45mL white wine with 40% alcohol or 150mL wine). 14) the compliance (number of PEF measurements completed/number of planned completions) in the induction period is less than 80% or PEF measurement is less than 5 days in the last 7 days of the induction period, or the operation and evaluation required by the study cannot be completed. 15) any conditionsthe investigators considers that are not suitable for the study. 16) the subject or his/her immediate family is directly involved in the design and implementation of the study. For example, as a investigator or a clinical research associate, the subject shall not be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1; | — |
Secondary
| Measure | Time frame |
|---|---|
| PEF;symptoms of asthma; | — |
Countries
China
Contacts
Public ContactLiu xi
Jiangsu Simcere Pharmaceutical Co. Ltd.
Outcome results
None listed