UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026060 |
|---|---|
| Receipt number | R000029944 |
| Scientific Title | Predictive factor for the effectiveness of bronchial thermoplasty in patients with asthma |
| Date of disclosure of the study information | 2017/02/10 |
| Last modified on | 2017/03/16 18:25:52 |
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Basic information
Public title
Predictive factor for the effectiveness of bronchial thermoplasty in patients with asthma
Acronym
PRE-THERMO
Scientific Title
Predictive factor for the effectiveness of bronchial thermoplasty in patients with asthma
Scientific Title:Acronym
PRE-THERMO
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find predictive factors for the effectiveness of the bronchial thermoplasty in patients with asthma.
Basic objectives2
Others
Basic objectives -Others
To find predictive factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discovery of the predictive factors for the effectiveness at 3 months after the final session of bronchial thermoplasty against bronchial asthma
Key secondary outcomes
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed as having asthma according to "Global Strategy for Asthma Management and Prevention (2016 update)".
2. Having asthma symptoms in the past year while receiving three or more controller medication including medium dose of inhaled corticosteroid or two or more controller medication including high dose of inhaled corticosteroid.
3. Receiving three or more controller medication including medium dose of inhaled corticosteroid or two or more controller medication including high dose of inhaled corticosteroid for more than 30 days.
4. Having asthma symptoms in the past while receiving high dose of inhaled corticosteroid and long-acting beta2-agonist.
Key exclusion criteria
1. Implantation of electoric device, such as a pacemaker.
2. Unable to receive medication which is used in the bronchoscopic procedure or in treatment of asthma exacerbation, such as lidocane, and systemic corticosteroid.
3. Previous history of bronchial thermoplasty or broncho-pulmonary surgery.
4. Severe complication such as respiratory infection, coagulation disorder, lung cancer, unstable ischemic heart disease and unstable cerebrovascular disease.
5. Unable to receive pulmonary function tests.
6. Intolerant of bronchoscopic procedure.
7. Women expecting a child or scheduled to be pregnant in 6 months.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kengo Murata |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Pulmonology
Zip code
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan
TEL
+81-42-323-5111
kengo_murata@tmhp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengo Murata |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Pulmonology
Zip code
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan
TEL
+81-42-323-5111
Homepage URL
kengo_murata@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo metropolitan goverment
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 02 | Month | 10 | 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 | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: Prospective study.
Recruitment;
Patients with asthma will be publicly recruited and be assessed for the eligibility at the outpatient clinic in Tama medical center.
Management information
Registered date
| 2017 | Year | 02 | Month | 08 | Day |
Last modified on
| 2017 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029944
