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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027662
Receipt No. R000031681
Scientific Title Clinical effects and mechanisms of bronchial thermoplasty for severe bronchial asthma
Date of disclosure of the study information 2017/06/07
Last modified on 2017/06/06

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Basic information
Public title Clinical effects and mechanisms of bronchial thermoplasty for severe bronchial asthma
Acronym Clinical trial on bronchial thermoplasty in patients with severe bronchial asthma
Scientific Title Clinical effects and mechanisms of bronchial thermoplasty for severe bronchial asthma
Scientific Title:Acronym Clinical trial on bronchial thermoplasty in patients with severe bronchial asthma
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the mechanisms and effects of bronchial thermoplasty on symptomatic improvement in subjects with severe bronchial asthma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The mean change in Asthma Quality of Life Questionnaire score from baseline to after bronchial thermoplasty
Key secondary outcomes 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

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mari Miki
Organization National Hospital Organization Toneyama National Hospital
Division name Department of Respiratory medicine
Zip code
Address 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552
TEL +81-6-6853-2001
Email marimiki@toneyama.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mari Miki
Organization National Hospital Organization Toneyama National Hospital
Division name Department of Respiratory medicine
Zip code
Address 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552
TEL +81-6-6853-2001
Homepage URL
Email marimiki@toneyama.go.jp

Sponsor
Institute National Hospital Organization Toneyama National Hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for Clinical Research from National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is performed as a prospective study to evaluate the mechanisms and effects of bronchial thermoplasty on symptomatic improvement in subjects with severe bronchial asthma.

Management information
Registered date
2017 Year 06 Month 06 Day
Last modified on
2017 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031681

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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