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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044207
Receipt No. 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 2021/11/30

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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
Email 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
Email kyoheim0423@gmail.com

Sponsor
Institute Osaka Red Cross Hospital
Institute
Department

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
Email 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 Unpublished

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
Results Delay Reason
Date of the first journal publication of results
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 No longer recruiting
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
2021 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.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


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