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Study on the safety and effectiveness of bronchoscopy cryo-balloon in the treatment of bronchial asthma

Study on the safety and effectiveness of bronchoscopy cryo-balloon in the treatment of bronchial asthma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037544
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-26

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

Conditions

asthma

Interventions

Case series:bronchoscopy cryo-balloons

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults 18-65 years old with asthma; 2. Have a history of asthma with a clear diagnosis and need to take asthma in the past 6 months The control drugs are as follows: high-dose ICS (inhaled glucocorticoid) beclomethasone >=1000ug/day (or equivalent drugs, other drugs and equivalent doses refer to Table 1 below) and LABA (long-acting ß2 receptor agonist) salmeterol >=100ug/day (or equivalent drugs). Other drugs that are allowed to be taken at the same time, including leukotriene modulators and OCS (oral glucocorticoid) =45% of the predicted value; 5. Patients who have no history of smoking or have smoked less than 10 packs for at least six months; 6. Baseline AQLQ (Asthma Quality of Life Questionnaire) score <=6.25; 7. Patients who have good compliance and can be followed up in outpatient clinics.

Exclusion criteria

Exclusion criteria: 1) FEV1 before bronchodilator use should account for less than 45% of the predicted value; 2) More than 3 hospitalizations due to worsening asthma in the past 12 months; 3) Need to use antibiotics for lower respiratory tract infections more than 3 times in the past 12 months; 4) In the past 12 months, oral glucocorticoids have been used due to worsening asthma more than 4 times; 5) Acute attack of chronic sinusitis; 6) Poorly controlled gastroesophageal reflux disease is defined as a significant increase in treatment in the past 6 weeks; 7) Hypersensitivity to drugs necessary for bronchoscopy (such as lidocaine, benzodiazepine); 8) Implantable electrical stimulation devices are installed in the patient's body, such as pacemakers and cardiac defibrillators; 9) Are using immunosuppressants (except glucocorticoids), beta-adrenergic receptor blockers, or anticoagulants; 10) Have a history of fatal asthma; 11) Uncontrolled severe obstructive sleep apnea; 12) Be admitted to ICU due to asthma attack within 2 years before treatment; 13) Patients with unhealed blood diseases or malignant tumors, and uncorrected blood coagulation disorders; 14) Patients with lung CT showing lower lobe bronchial stenosis or complete distal atelectasis, or other severe bronchial and lung solid diseases; 15) The investigator judges that the patient has poor compliance and cannot complete the study as required, or believes that the patient has other medical conditions that are not suitable for this study; 16) There are contraindications related to bronchoscopy; 17) Women who are pregnant or breastfeeding or patients who have a childbirth plan within the next year; 18) Patients who have previously received bronchial cryo-balloon therapy.

Design outcomes

Primary

MeasureTime frame
Effect and safety;

Secondary

MeasureTime frame
Quality of Life;adverse event;

Contacts

Public ContactLi Xuan

Shanghai Tenth People's Hospital

lixuan11299211@163.com+86 18917681795

Outcome results

None listed

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