UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023817 |
|---|---|
| Receipt number | R000027307 |
| Scientific Title | Correlation between the CD4 cell counts and the pathogenesis and treatment of bronchial asthma. |
| Date of disclosure of the study information | 2016/10/10 |
| Last modified on | 2022/02/14 11:06:43 |
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Basic information
Public title
Correlation between the CD4 cell counts and the pathogenesis and treatment of bronchial asthma.
Acronym
Correlation between the CD4 cell counts and bronchial asthma.
Scientific Title
Correlation between the CD4 cell counts and the pathogenesis and treatment of bronchial asthma.
Scientific Title:Acronym
Correlation between the CD4 cell counts and bronchial asthma.
Region
| Japan |
Condition
Condition
HIV infection
Bronchial Asthama
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify, 1)the incidense of bronchial asthma in HIV positive patients, 2)disease activity correlate with the CD4 cell counts.
Basic objectives2
Others
Basic objectives -Others
To clarify the efficacy and safety of brochial asthma drugs.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Comobidity of bornchial asthma or atopic dermatitis in HIV positive patients.
2. To clarify the efficacy and safety of inhaled corticosteroids.
Key secondary outcomes
1-1. To discover the factor attribute to bronchial asthma onset.
1-2. To evaluate the correlation between airway hyper-responsiveness and lung function and CD4 cell counts.
2-1. Can inhaled corticosteroid reduce the frequency of SABA inhaler use.
2-2. To clarify the correlation between CD4 cell counts and asthma therapy.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Inhaled corticosteroid
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Over 20 year-old.
2.Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form.
3.Subjects must be documented HIV-seropositivity (enzyme-linked immunosorbent assay confirmed with Western blot analysis or polymerase chain reaction.
4.Condition is stable at least 4 weeks over.
Key exclusion criteria
1.Presence of a known pre-existing, clinically important lung condition. This includes current infection or a history of cancer.
2.Subjects can not read, comprehend,and write at a level sufficient to complete study related materials.
3.Severe bronchial asthma
4.Subjects who are pregnant or breastfeeding.
5.HIV virus was infected by blood components.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tominaga |
Organization
Kurume University School of Medicine
Division name
Division of Respirology, Neurology and rheumatology, Department of Medicine 1
Zip code
8300011
Address
67 Asahi-machi, Kurume-city, Fukuoka, 830-0011, Japan
TEL
0942-31-7560
tominaga_masaki@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tominaga |
Organization
Kurume University School of Medicine
Division name
Division of Respirology, Neurology and rheumatology, Department of Medicine 1
Zip code
8300011
Address
67 Asahi-machi, Kurume-city, Fukuoka, 830-0011, Japan
TEL
0942-31-7560
Homepage URL
tominaga_masaki@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine.
Division of Respirology, Neurology and rheumatology, Department of Medicine 1
Institute
Department
Personal name
Funding Source
Organization
Kurume University School of Medicine.
Division of Respirology, Neurology and rheumatology, Department of Medicine 1
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
Kurume University
Address
Asahimachi 67, Kurume city, Fukuoka
Tel
0942317560
tominaga_masaki@med.kurume-u.ac.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
| 2016 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
not published
Publication of results
Unpublished
Result
URL related to results and publications
not published
Number of participants that the trial has enrolled
44
Results
Among 44 patients written consents, 20 had AHR, and only characteristics of asthma before HIV infections was an independent risk factor for AHR. However, only three patients had lower QOL. In patients with AHR, the QOL levels were independently and significantly associated with AHR levels depended on decline blood CD4 cells count.
Results date posted
| 2021 | Year | 03 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All patients with stable HIV infections on regular visits to our clinic were consecutively enrolled.
Participant flow
All patients visit to our hospital.
Adverse events
None
Outcome measures
Each patient was required quality of life (QOL), conditions of HIV infections, sensitization to allergens, sputum and blood cell differentiations, and spirometry and methacholine challenge tests. Patients with AHR were required the above reproducible tests again 3 months after.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 10 | Day |
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 29 | Day |
Last modified on
| 2022 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027307
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/08/30 | HIV&BA_研究計画書_09052016.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
