Unique ID issued by UMIN | UMIN000026176 |
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Receipt number | R000030038 |
Scientific Title | Prospective observational study for exploring biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with bronchial asthma |
Date of disclosure of the study information | 2017/02/20 |
Last modified on | 2021/02/19 16:07:55 |
Prospective observational study for exploring biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with bronchial asthma
Prospective observational study for exploring biomarkers of bronchial thermoplasty
Prospective observational study for exploring biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with bronchial asthma
Prospective observational study for exploring biomarkers of bronchial thermoplasty
Japan |
Bronchial asthma
Pneumology | Clinical immunology |
Others
YES
Exploring biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with asthma
Safety,Efficacy
Exploratory
Not applicable
Exploring biomarkers of bronchial thermoplasty in bronchial asthma by the method of omics approach
Unexpected visits and admission for exacerbation of bronchial asthma
Change of bronchial asthma related quality of life, spirometry parameters and fractional exhaled nitric oxide
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) Previously treated over a year after diagnosis of bronchial asthma
2) Bronchial asthma requiring regular maintenance medication that includes high dose inhaled corticosteroid and long acting beta2 agonist,
Willingness and ability to bronchial thermoplasty
3) Permit the other medication in combination such as anti-leukotriene antagonists, xanthine derivatives, omalizumab and systemic corticosteroids within 10 mg/day, expectorants
4) Adequate organ functions
5) Life expectancy more than a year
6) Willingness and ability to give written informed consent
1) Implantation of an internal or external pacemaker or internal cardiac defibrillator
2) Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine and benzodiazepines
3) lower respiratory tract infection
4) Unstable asthma with an increased does of systemic corticosteroids within 2 weeks
5) Known coagulopathy
6) As with other bronchoscopic procedures, patients should stop taking anticoagulants, antiplatelet agents, aspirin, and NSAIDs before the procedure with physician guidance
7) Any other condition, which in the opinion of the investigator would preclude participation in the study
30
1st name | Hiroaki |
Middle name | |
Last name | Tsurumaki |
Gunma University Hospital
Division of Allergy and Respiratory Medicine
371-8511
3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan
027-220-8130
m12702056@gunma-u.ac.jp
1st name | Hiroaki |
Middle name | |
Last name | Tsurumaki |
Gunma University Hospital
Division of Allergy and Respiratory Medicine
3718511
3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan
027-220-8130
m12702056@gunma-u.ac.jp
Gunma University
non
Self funding
Gunma University Hospital Institutional Review Board
3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan
027-220-8740
gunmaciru-office@umin.ac.jp
NO
群馬大学医学部附属病院(群馬県)/Gunma University Hospital(Gunma)
2017 | Year | 02 | Month | 20 | Day |
Unpublished
3
Completed
2017 | Year | 02 | Month | 01 | Day |
2017 | Year | 01 | Month | 26 | Day |
2017 | Year | 02 | Month | 01 | Day |
2021 | Year | 01 | Month | 31 | Day |
2021 | Year | 02 | Month | 19 | Day |
2021 | Year | 02 | Month | 19 | Day |
2021 | Year | 02 | Month | 19 | Day |
Study design; Prospective observational study
Registration: February. 2016 to January. 2020, compatible with inclusion criteria.
Using blood sample and exhaled breath condensate, any biomarkers before and after bronchial thermoplasty are measured. We explore biomarkers predictive for clinical efficacy in a year after bronchial thermoplasty.
2017 | Year | 02 | Month | 16 | Day |
2021 | Year | 02 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030038
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