A prospective, open, single-center, single-arm medical device trial evaluating the clinical feasibility and safety of cryoablation combined with bronchial thermoplasty (BT) for severe asthma

Study on the mechanism of bronchial thermoplasty by regulating airway smooth muscle cells autophagy and inhibiting airway remodeling in the treatment of severe asthma

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200063147

Enrollment

Unknown

Registered

2022-08-31

Start date

2022-09-01

Completion date

Unknown

Last updated

2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

Experimental group:Bronchial thermoplasty combined with airway cryotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 68 Years

Inclusion criteria

Inclusion criteria: 1. Have a clear history of asthma and have taken the following asthma control medications in the past 6 months: High doses of ICS (inhaled glucocorticoid) beclomethasone >=1000ug/ day (or equivalent) and LABA (long-acting ß2 agonist) salmeterol >=100ug/ day (or equivalent) concomitant administration of other medications, including leucine regulators and OCS<=10mg/ day; 2. Stable medication at least 3 weeks before enrollment, and asthma symptoms at least 2 days before enrollment; 3. Predicted value of pulmonary function test during screening: 35% of predicted value before bronchodilator < FEV1 < 80% of predicted value; 4. Patients who have no smoking history or have smoked less than 10 packs per year for at least one year; 5. Baseline AQLQ (Asthma Quality of Life Questionnaire) score <=6.25.

Exclusion criteria

Exclusion criteria: 1. Hospitalization for asthma exacerbation more than 3 times in the past 12 months; 2. Antibiotics have been required for more than three infections due to lower respiratory infections in the past 12 months; 3. Oral glucocorticoids have been required at least four times in the past 12 months due to exacerbation of asthma; 4. Acute onset of chronic sinusitis; 5. Poorly controlled gastroesophageal reflux disease, defined as a significant increase in treatment over the past 6 weeks; 6. Allergic to drugs (such as lidocaine, benzodiazepines) required for bronchoscopy; 7. Patients have implanted electrical stimulation devices, such as pacemakers, cardiac defibrillators, or deep neural or deep brain stimulators.

Design outcomes

Secondary

Measure	Time frame
Number of severe acute exacerbations of asthma;Score of Asthma Quality of Life Questionnaire (AQLQ);Score of Asthma Control Questionnaire (ACQ-6);Score of Asthma Control Test (ACT);	—

Primary

Measure	Time frame
Surgical success rate;	—

Countries

China

Contacts

Public ContactLong Fa

Shenzhen Hospital, Chinese Academy of Sciences (Guangming)

longfa_923@163.com+86 13651472098

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026