UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044207 |
|---|---|
| Receipt number | R000050423 |
| Scientific Title | Clinical efficacy of bronchial thermoplasty for severe bronchial asthma |
| Date of disclosure of the study information | 2021/05/14 |
| Last modified on | 2023/03/22 18:07:25 |
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Basic information
Public title
Clinical efficacy of bronchial thermoplasty for severe bronchial asthma
Acronym
Clinical efficacy of bronchial thermoplasty for severe bronchial asthma
Scientific Title
Clinical efficacy of bronchial thermoplasty for severe bronchial asthma
Scientific Title:Acronym
Clinical efficacy of bronchial thermoplasty for 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 clinical efficacy of bronchial thermoplasty in severe bronchial asthma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in AQLQ score from baseline survey to 3, 6, and 12 months after bronchial thermoplasty.
Key secondary outcomes
Change in %FEV1 and severe exacerbations from baseline survey to 3, 6, and 12 months after bronchial thermoplasty.
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
Patients who completed bronchial thermoplasty at the Department of Respiratory Medicine, Osaka Red Cross Hospital between September 1, 2017 and October 31, 2019, and are continuously attending the outpatient clinic as of October 31, 2020.
Key exclusion criteria
Patients who failed to complete bronchial thermoplasty or discontinued hospital visits within one year of the procedure.
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishikawa |
Organization
Osaka Red Cross Hospital
Division name
Department of respiratory medicine
Zip code
543-8555
Address
5-30, Fudegasaki-cho, Tennoji-ku, Osaka City, Osaka
TEL
0667745111
takatsukasa66@gmail.com
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Morita |
Organization
Osaka Red Cross Hospital
Division name
Department of respiratory medicine
Zip code
543-8555
Address
5-30, Fudegasaki-cho, Tennoji-ku, Osaka City, Osaka
TEL
0667745111
Homepage URL
kyoheim0423@gmail.com
Sponsor or person
Institute
Osaka Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Red Cross Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Red Cross Hospital
Address
5-30, Fudegasaki-cho, Tennoji-ku, Osaka City, Osaka
Tel
0667745154
hospital@osaka-med.jrc.or.jp
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
| 2021 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
https://www.osaka-med.jrc.or.jp/aboutus/information/pdf/ethics-i_09.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.osaka-med.jrc.or.jp/aboutus/information/ethics.html
Number of participants that the trial has enrolled
21
Results
At the follow-up assessment, the AQLQ scores, mOCS doses, and exacerbation frequency were improved, while %FEV1 did not change. Next, we grouped the patients into two according to their BMI levels. At 12 months after the procedure, the AQLQ scores were significantly improved in patients with overweight/obesity. In MANOVA, the degree of slopes significantly differed between the lines of overweight/obesity and normal weight in terms of the AQLQ scores (P = 0.01).
Results date posted
| 2021 | Year | 11 | Month | 30 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Under review
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 20 | Day |
Baseline Characteristics
We used data from patients with severe asthma who underwent BT at Osaka Red Cross Hospital between September 2017 and October 2019.
Participant flow
A total of three procedures were performed on the right lower lobe, left lower lobe, and bilateral upper lobes (excluding the middle lobe) in the order of admission with an interval of at least three weeks.
Adverse events
pneumonia, worsening of asthma, atelectasis
Outcome measures
We collected clinical data recorded at the last visit before BT (baseline assessment) and at 12 months after BT (follow-up assessment). Exacerbation was defined as worsening in asthma control, thereby requiring systemic corticosteroids or doubling or more the daily doses of baseline maintenance oral corticosteroid (mOCS) for at least 3 days. According to the Minimal Clinically Important Difference in Asthma Quality of Life Questionnaire (AQLQ), an increase of 0.5 points was used.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For research subjects, clinical information will be obtained from electronic medical records immediately before, 3 months, 6 months, and 12 months after the introduction of bronchial thermoplasty.
Management information
Registered date
| 2021 | Year | 05 | Month | 14 | Day |
Last modified on
| 2023 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050423
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/11/30 | ethics-i_09.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
