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Effectiveness and safety of bronchial thermoplasty multicenter study in Japan

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000028391
Enrollment
200
Registered
2017-07-29
Start date
2017-08-28
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

None listed

Sponsors

Department of Pulmonary Medicine and Clinical Immunology, Dokkyo Medical University School of Medicine
Lead Sponsor
Boston Scietific Japan Co. Ltd
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 doseof 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)

Secondary

MeasureTime frame
1.Asthma exacerbation 2.Emergency room visits 3.Unscheduled physician office visits 4.Hospitalization frequency 5.Hospitalizations 6.Days missed from work/school 7.Physician's Global Evaluation of Treatment Effectiveness (GETE) assessment 8.Therapeutic drug use 9.Pulmonary function 10.Adverse events

Countries

Japan

Contacts

Public ContactAkihiro Takemasa

Dokkyo Medical University School of Medicine Department of Pulmonary Medicine and Clinical Immunology

takemasa@dokkyomed.ac.jp0282861111

Outcome results

None listed

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