asthma
Conditions
Interventions
Interventional group:Airway cryotherapy
Sponsors
Shanghai Dongfang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age >18 and < 65 years, male or female; 2.Confirmed diagnosis of severe asthma, regular use of maintenance drugs in the past 12 months, including: 2.1High-dose inhaled corticosteroid (ICS) beclomethasone =1000µg/day, long-acting ß2 receptor agonist (LABA) salmeterol =100µg/day 2.2Other anti-asthmatic drug, e.g., leukotriene modifier and anti-IgE antibody, are acceptable (subjects receiving omalizumab must take it for more than one year) 3.Asthma must meet the following requirements:(A)B-agonist FEV 1 = 12%, 360 mcg salbutamol or(B)Methylcholine FEV1 PC20 < 4mg/ml, ICS not administered or = 16 mg/ml 4.FEV1=50% before bronchodilation, and EFV1=60% after bronchodilation 5.Asthmatic symptoms lasting for at least two days or one night per week in the past two weeks 6.No smoking for at least one year (a history of smoking for less than 10 years for previous smokers) 7.Being able to undergo bronchoscopy and cryotherapy, as considered by investigators 8.Signature of informed consent
Exclusion criteria
Exclusion criteria: 1.Persistent aggravation of asthma within 4 weeks (emergency visit, hospitalization, increased dose of systemic steroids) 2.Being hospitalized for three times or more for aggravation of asthma, or admission to emergency room for once or more for asthma within one year before participation in this clinical study 3.Oral use of chronic steroid 30mg required per day 4.Other respiratory tract diseases, including interstitial lung disease, pulmonary emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, untreated obstructive sleep apnea, Churg–Strauss syndrome, cardiac insufficiency and allergic bronchopulmonary aspergillosis (total IgE>1000 units/mL, specific Aspergillus IgE positive, with evidence on central bronchodilation) 5.X-CT scan confirmed segmental atelectasis, consolidation of pulmonary lobe, obvious or unstable pulmonary infiltration or pneumothorax 6.Clinically serious cardiovascular disease, including myocardial infarction, angina pectoris, arrhythmia, conduction defect, myocardiopathy, aortic aneurysm or stroke 7.Uncontrollable hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >100 mmHg) 8.Use of internal or external pacemaker or cardiac defibrillator 9.Chronic diseases (except asthma), which may prevent subjects from participation in the study or place them at risk through participation in the study, e.g., pulmonary disease (except asthma), cardiac, hepatic, renal or neurological chronic disorders, or immune deficiency 10.Having participated in other clinical study within one month 11.Other reasons for failure to be included for treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma control test (ACT) score;Change in FEV1 from baseline at pre-specified time points before and after bronchodilator treatment;Evaluation of surgical complications, using the percentage of individuals with adverse events of the clinical trial device in the total study population (common terminology criteria for adverse events (CTCAE) V5.0);Incidence of respiratory serious adverse events during the follow-up;Main performance endpoint of this product includes 1) device success, defined as the capability to insert, place and remove the device; 2) technical success, defined as being able to reach the targeted location accurately and complete cryoablative procedure.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Operation time;Asthma control questionnaire (ACQ) score;Asthma diary;Change in the dose of maintenance drugs for asthma;Pulmonary function (FVC, FEV1/FVC and FEV1%pre);Change in peak expiratory flow (PEF) in the morning and evening;CT evaluation; | — |
Countries
China
Contacts
Public ContactQiang Li
Shanghai Dongfang Hospital
Outcome results
None listed