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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023817
Receipt No. 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 2018/03/05

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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
Middle name
Last name Masaki Tominaga
Organization Kurume University School of Medicine
Division name Division of Respirology, Neurology and rheumatology, Department of Medicine 1
Zip code
Address 67 Asahi-machi, Kurume-city, Fukuoka, 830-0011, Japan
TEL 0942-31-7560
Email tominaga_masaki@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Tominaga
Organization Kurume University School of Medicine
Division name Division of Respirology, Neurology and rheumatology, Department of Medicine 1
Zip code
Address 67 Asahi-machi, Kurume-city, Fukuoka, 830-0011, Japan
TEL 0942-31-7560
Homepage URL
Email tominaga_masaki@med.kurume-u.ac.jp

Sponsor
Institute Kurume University School of Medicine.
Division of Respirology, Neurology and rheumatology, Department of Medicine 1
Institute
Department

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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 10 Day
Date of IRB
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

Other
Other related information

Management information
Registered date
2016 Year 08 Month 29 Day
Last modified on
2018 Year 03 Month 05 Day


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


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