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Effectiveness and safety of bronchial thermoplasty-A multicenter study in Japan

Effectiveness and safety of bronchial thermoplasty-A multicenter study in Japan - A multicenter study of bronchial thermoplasty in Japan

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028427
Enrollment
200
Registered
2017-08-01
Start date
2017-08-01
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

Severe asthma

Interventions

bronchial thermoplasty(3 times every 3 weeks)

Sponsors

Japanese study group for bronchial thermoplasty(J-brothers)
Lead Sponsor
Japanese study group for bronchial thermoplasty(J-brothers)
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Uncontrolled severe asthma patients treated with high dose inhaled corticosteroid and long-acting beta2-agonists. 2. Eligible for fiberoptic bronchoscopy.

Exclusion criteria

Exclusion criteria: 1. Have a pacemaker, implantable cardioverter defibrillator, or other implantable electronic device. 2. Have a known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine, and benzodiazepines. 3. Have been previously treated with BT 4. Active respiratory infection 5. Asthma exacerbation or changing dose of systemic corticosteroids for asthma in the past 14 days 6. Known coagulopathy. As with other bronchoscopic procedures, patients should stop taking anticoagulants, antiplatelet agents, aspirin, and NSAIDS before the procedure with physician guidance

Design outcomes

Primary

MeasureTime frame
QOL (quality of life)(at 3M,6M,and 12M)

Secondary

MeasureTime frame
Asthma exacerbation Emergency room visits Unscheduled physician office visits Hospitalization frequency Hospitalizations Days missed from work/school Physician's Global Evaluation of Treatment Effectiveness (GETE) assessment Therapeutic drug use Pulmonary function Adverse events (at 3M,6M,and 12M)

Countries

Japan

Contacts

Public ContactAkihiro Takemasa

Dokkyo Medical University Hospital Department of Pulmonary Medicine and Clinical Immunology

takemasa@dokkyomed.ac.jp0282-87-2151

Outcome results

None listed

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