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Efficacy, safety, and pulmonary functions of bronchial thermoplasty in patients with severe asthma

Efficacy, safety, and pulmonary functions of bronchial thermoplasty in patients with severe asthma - Efficacy, safety, and pulmonary functions of bronchial thermoplasty in patients with severe asthma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035416
Enrollment
20
Registered
2018-12-31
Start date
2018-04-01
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

bronchial asthma

Interventions

Sponsors

Tokyo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Severe uncontrolled bronchial asthma on high-dose inhaled corticosteroids, which is equivalent to 1000 or more micro g/day of beclomethasone dipropionate and long-acting beta 2 agonist 2)Ability to tolerate bronchoscopy and suitable for bronchial thermoplasty 3)Aged 20 years old and older 4)Provided written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1)Malignant tumors 2)Severe heart disease 3)Severe hepatic failure 4)Severe renal failure (serum creatinine levels 2.0 or more mg/dl) 5)Current use of a body defibrillator, such as pacemaker or implantable cardioverter defibrillator 6)Active infectious disease 7)Exacerbation of asthma or change in the drug regimen to include oral corticosteroids in the past 14 days 8)Change in the maintenance drug therapy for bronchial asthma in the past 4 weeks 9)Less than 65% post-bronchodilator %FEV1 10)Uncontrolled sinusitis 11)Requirement for oral steroid that is equivalent to more than 10 mg/day of prednisone to control bronchial asthma 12)Past history of intubation or admission to the intensive care unit due to bronchial asthma in the past 24 months 13)Past history in the past 12 months as follows; i) 4 or more infections of the lower respiratory tract, or ii) 3 or more admissions due to respiratory symptoms 14)Has smoked in the past 12 months or has a smoking history of 10 or more pack-years 15)Has previously undergone bronchial thermoplasty 16)Pregnancy or potential pregnancy 17)Judged inadequate to participate in the study by their physicians

Design outcomes

Primary

MeasureTime frame
Post BT treatment complications, therapeutic control level, pulmonary functions

Countries

Japan

Contacts

Public ContactShinji Teramoto

Tokyo Medical University Hachioji Medical Center Department of Respiratory Medicine

shinjit-tky@umin.ac.jp042-665-5611

Outcome results

None listed

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