UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041913 |
|---|---|
| Receipt number | R000047333 |
| Scientific Title | Identification of volatile organic compounds that specify severe asthma phenotypes in Japan |
| Date of disclosure of the study information | 2020/09/28 |
| Last modified on | 2023/12/11 14:27:15 |
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Basic information
Public title
Identification of volatile organic compounds
that specify severe asthma phenotypes in Japan
Acronym
J-VOCSA Trial
Scientific Title
Identification of volatile organic compounds
that specify severe asthma phenotypes in Japan
Scientific Title:Acronym
J-VOCSA Trial
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to identify volatile organic compounds (VOCs) that specify asthma phenotypes among Japanese severe asthma patients.
Basic objectives2
Others
Basic objectives -Others
This study aims to identify volatile organic compounds (VOCs) that specify asthma phenotypes among Japanese severe asthma patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of difference in the distribution of VOCs among severe asthma phenotypes.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Asthma patients who met all the criteria listed below.
1) Asthma patients previously enrolled for NHOM-Asthma study
2) Severe asthma patients (asthma patients receiving GINA Step 4 or 5 treatment)
3) Asthma patients visiting participating hospitals
4) Asthma patients being able to provide informed consent
5) Asthma patients aged 16 years or older at time of acquisition of informed consent
Healthy control subjects (healthy control subjects will be recruited from the hospital workers at participating hospitals)
1) Subjects aged 20 years or older at time of acquisition of informed consent
2) Subjects being able to provide informed consent
3) Subjects without any disease on treatment
Key exclusion criteria
1) As a result of medical interview, physical examination or investigation, the physician responsible considers the subject unfit for the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Maho |
| Middle name | |
| Last name | Suzukawa |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
204-8585
Address
3-1-1 Takeoka, Kiyose-Shi, Tokyo, Japan
TEL
042-491-2111
fueta-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Maho |
| Middle name | |
| Last name | Suzukawa |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
204-8585
Address
3-1-1 Takeoka, Kiyose-Shi, Tokyo, Japan
TEL
042-491-2111
Homepage URL
fueta-tky@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Tokyo National Hospital
Institute
Department
Personal name
Funding Source
Organization
GlaxoSmithKlin
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Review Board for Clinical Trials (Nagoya)
Address
4-1-1 Sannomaru, Naka-ku Nagoya, Aichi 460-0001, Japan
Tel
052-951-1111
311-rec@mail.hosp.go.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
| 2020 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
not applicable
Publication of results
Unpublished
Result
URL related to results and publications
not applicable
Number of participants that the trial has enrolled
245
Results
GC/MS detected 243 VOCs, and 142 frequently detected VOCs were used for statistical analyses. Cluster analysis showed the highest similarities between clusters 3 and 4 (early-onset clusters), followed by the similarities between clusters 1 and 2 (late-onset clusters). Comparisons between clusters 1- 5 and HC revealed 19 VOCs, in which only methanesulfonic anhydride showed p < 0.05 adjusted by false discovery rate. Comparison of these clusters yielded several VOCs showing different trends (p < 0.05).
Results date posted
| 2023 | Year | 12 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of these, three patients with asthma had some missing data required for the tree analysis to assign phenotypes.1 Finally, 245 patients with asthma and 50 HC were subjected to the tree analysis and analyzed for VOCs. The baseline characteristics of patients with asthma and HC are summarized in Table 1. Patients with asthma were assigned an asthma phenotype according to a previously described decision tree.1 As in the previous report, the characteristics of the five clusters were in accordance with those of NHOM-asthma, a nationwide prospective, multicenter observational cohort study conducted at 27 hospitals in Japan, and the details of the study design have been published previously,1 except for male dominance in cluster 5: cluster 1, late-onset, old, less atopic; cluster 2, late-onset, old, eosinophilic, low FEV1; cluster 3, early onset, long-duration, atopic, poorly controlled; cluster 4, early onset, young, female-dominant, atopic; and cluster 5, female-dominant, T1/T2-mixed, and most severe. However, the distribution of the participants became uneven; five asthma cases were included in cluster 5; in contrast, the other clusters had more than 30 asthma cases.
Participant flow
A total of 256 patients with asthma and 50 HC were enrolled in this study. Of the enrolled patients, eight patients with asthma were withdrawn, and 248 patients with asthma and 50 HC were subjected to analysis .
Adverse events
not applicable.
Outcome measures
Analysis of VOCs among asthma phenotypes
Comparison of VOCs between patients with asthma and HCs
Comparison of VOCs between late- and early-onset clusters (clusters 1, 2, and clusters 3 and 4)
VOCs for distinguishing cluster 5 from clusters 1-4.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2020 | Year | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047333
