Bronchial asthma
Conditions
Interventions
None listed
Sponsors
National Hospital Organization Osaka Toneyama Medical Center
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 18 years or 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
| Measure | Time frame |
|---|---|
| The mean change in Asthma Quality of Life Questionnaire score from baseline to after bronchial thermoplasty | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean changes in the following parameters from baseline to after bronchial thermoplasty: 1) results of cardiopulmonary exercise testing, which include exercise time, peak Vo2, Borg scale, O2-pulse, VD/VT,VE/Vo2, VE/Vco2, delta FiO2, and ETCO2; 2) low frequency (LF) component, high frequency (HF) component, and LF/HF, which will be measured using heart rate variability during the day and at night alone; 3) Asthma Control Test score; 4) peak expiratory flow; 5) forced expiratory volume in one second (FEV1); 6) measurements of respiratory resistance and respiratory reactance, including R5, R20, R5-R20, and Fres; 7) results of the methacholine challenge test using the astograph methods, including Dmin and SGrs/Grs count; 8) the frequency of rescue drug (i.e., short-acting beta 2 agonist) use; and 9) frequency of clinical exacerbation of asthma, which requires steroid administration | — |
Countries
Japan
Contacts
Public ContactKeisuke Miki
National Hospital Organization Osaka Toneyama Medical Center Department of Respiratory medicine
Outcome results
None listed