asthma
Conditions
Interventions
Sponsors
Shanghai Dongfang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1)Male or female aged 18 ~ 65 years (inclusive) at the time of signature of informed consent form 2)Not controlled after good compliance with treatment with high-dose inhaled glucocorticoid – long-acting ß2 receptor agonist (ICS-LABA) using proper inhalation technique, presence of at least one of the following symptoms within stable conventional drug therapy for 4 weeks: A.Daytime asthma symptoms > twice per week; B.Waking up at night due to asthma; C.Need to use rescue medication SABA (short-acting ß2 receptor agonist, e.g., Salbutamol) > twice per week; D.Limitation of activity for asthma. Or requiring high-dose ICS-LABA for control (i.e., asthma not controlled after down-stage treatment) 3)Forced expiratory volume in the first second (FEV1)% >=?50% of the predicted value before use of bronchodilators (during conventional drug therapy) 4)No smoking or abstinence from smoking for >= 1 year 5)Being able to undergo bronchoscopy as considered by investigators in accordance with 2022 GINA guideline and guidelines on bronchoscopy 6)Compliance with study protocol, cooperation with study observation 7)Agreement upon participation in the study and signature of informed consent fo
Exclusion criteria
Exclusion criteria: 1)Need to use systemic corticosteroids for acute attack of asthma within 7 days prior to enrollment 2)History of life-threatening asthma, including intubation for asthma in the past or admission to the intensive care unit for asthma in the past two years; or admission for severe acute attack of asthma for >=?3 times in the past one year 3)Admission for lower respiratory tract infection (including bronchitis, pneumonia, bronchiectasia, etc.) for >=?2 times in the past one year; or having had lower respiratory tract infection within 4 weeks prior to enrollment; or having had upper respiratory tract infection within 7 days prior to enrollment 4)Having chronic obstructive pulmonary disease, chronic sinusitis, obstructive sleep-disordered breathing, as well as clear bronchial dilation or stenosis, atelectasis, or other serious pulmonary diseases 5)BMI35 kg/m2 6)Known serious gastrointestinal motility disorder, gastroesophageal reflux or previous history of gastric, esophageal or pancreatic surgery (open or laparoscopic) 7)Platelet count 1.5) 8)Uncontrollable hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >100 mmHg), or previous diagnosis of pulmonary hypertension 9)Myocardial infarction, clinically significant grade III or IV (NYHA) congestive heart failure, unstable angina pectoris, serious arrhythmia, myocardiopathy or other possibly life-threatening cardiac disorders in the past 6 months 10)Combined with serious dysfunction of other important organs, e.g., stroke, hemiplegia, convulsion, epilepsy, etc., known aortic dissection, aortic aneurysm, potential malignant tumor currently under evaluation, severe hepatic and renal failure as well as bacteriemia, toxaemia or other severe infectious diseases 11)Known contraindications for routine bronchoscopic procedure, being allergic to or contraindicated for general anesthesia or perioperative drugs or components 12)Pregnant or lactating women, or women who plan for pregnancy in the next one year 13)Previous or ongoing participation in clinical study for other drugs or medical device within 3 months prior to enrollment 14)Other conditions considered by investigators as unsuitable for the study, e.g., inappropriate anatomical structure, mental disorder or psychological disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: annual frequency of severe acute attack of asthma (within 12 months); | — |
Secondary
| Measure | Time frame |
|---|---|
| Asthma quality of life questionnaire (AQLQ) score (S);Asthma control questionaire (ACQ-7) score;Cough and sputum assessment questionnaire (CASA-Q);FEV1% before and after use of bronchodilator;?Bronchial provocation test (change of methacholine PC20);Percentage of asymptomatic days based on patient’s diary;Frequency of first-aid drug use;?Breathing related visit to emergency room, hospitalization, unscheduled office visit, including time of visits to emergency care; | — |
Countries
China
Contacts
Public ContactQiang Li
Shanghai Dongfang Hospital
Outcome results
None listed