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Multicenter trial of effectiveness and safety of bronchial thermoplasty in bronchial asthma

Multicenter trial of effectiveness and safety of bronchial thermoplasty in bronchial asthma - J-Breath

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000025244
Enrollment
40
Registered
2016-12-13
Start date
2016-12-22
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Bronchial asthma

Interventions

None listed

Sponsors

Japanese Red Cross Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with bronchial asthma according to general allergy guideline 2016 2) Patients with bronchial asthma using high-dose inhaled corticosteroids and long-acting beta 2 agonists 3) Patients who obtain written consent regarding the participation of this study

Exclusion criteria

Exclusion criteria: 1) Patients using a body defibrillator such as a pacemaker or ICD 2) Patients who have previously received bronchial thermoplasty (BT) 3) Patients with severe complications such as heart disease, liver disease or kidney failure 4) Patients with respiratory infection, blood coagulation disorder 5) Patients who had exacerbation of asthma or dose change of oral corticosteroids in the past 14 days 6) Patients who can not use drugs required for bronchoscopic procedures such as lidocaine, atropine, benzodiazepine type anxiolytic drugs 7) Patients with bronchial asthma-COPD overlap syndrome (ACOS) 8) Other patients judged unsuitable as subjects by doctor's judgment

Design outcomes

Primary

MeasureTime frame
Incidence rate of adverse events of Grade 3 or higher onset occurring within 90 days after the final treatment

Secondary

MeasureTime frame
1. Incidence rate of adverse events of Grade 1 or higher after each treatment 2. Asthma control after each treatment (ratio of number of strokes per week, rate of unscheduled outpatient visits in 1 week (including emergency outpatient visit)) 3. Drug reduction effect after final treatment 4. Change in bronchial wall thickening after each treatment 5. Each treatment time 6. Activation count for each treatment 7. Adverse events of Grade 1 or higher from primary evaluation to 1 year after the last treatment

Countries

Japan

Contacts

Public ContactTakehiro Izumo

Japanese Red Cross Medical Center Respiratory Medicine

drtake1118@gmail.com03-3400-1311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026