UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between viral load and cough in elderly patients with influenza.
Acronym	Relationship between viral load and cough in elderly patients with influenza.
Scientific Title	Relationship between viral load and cough reflex sensitivity in elderly patients with influenza infection
Scientific Title:Acronym	Relationship between viral load and cough reflex sensitivity in elderly patients with influenza infection
Region	Japan

Condition
Condition	influenza
Classification by specialty	Infectious disease Geriatrics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Influenza is a viral infection that should be emphasized in the elderly. This is particularly a problem for the elderly because many patients become severe with secondary bacterial pneumonia. The general clinical picture of influenza is as high as 38 to 40 degrees. However, as for cough symptoms in influenza patients, although there are previous studies in healthy adults, we have not conducted any studies in the elderly population so far. Not. Moreover, there is no report which investigated the amount of influenza viruses scattered with cough over time. Therefore, in this study, we investigate the amount of virus scattering due to influenza cough and changes over time in the cough reflex in elderly people.
Basic objectives2	Others
Basic objectives -Others	Change over time Infection prevention
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Cough frequency
Key secondary outcomes	Virus count Cough impulse

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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Residents of elderly facilities who cooperate with research. 65 years old or older.
Key exclusion criteria	Unable to obtain consent for this research. Problems with cognitive function such as dementia. Using ventilators. Severe dysphagia. Having respiratory diseases such as asthma and cough asthma. Those taking antitussives. Unable to maintain a stable posture. The doctor judged that participation in the research was difficult, such as severe flu symptoms.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name MASAHIRO Middle name Last name KOZUKI
Organization	Tohoku University School of Medicine
Division name	Internal Medicine and Rehabilitation Science
Zip code	980-8574
Address	1-1 Seiryocho, Aoba-ku, Sendai
TEL	022-717-7353
Email	kohzukip@med.tohoku.ac.jp

Public contact
Name of contact person	1st name KENJI Middle name Last name MURAKAMI
Organization	Tohoku University School of Medicine
Division name	Internal Medicine and Rehabilitation Science
Zip code	980-8574
Address	1-1 Seiryocho, Aoba-ku, Sendai
TEL	022-717-7353
Homepage URL
Email	k_murakami@seiyogakuin.ac.jp

Sponsor
Institute	Tohoku University School of Medicine. Internal Medicine and Rehabilitation Science.
Institute
Department

Funding Source
Organization	Sendai Medical Center Virus Research Center.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	Sendai Medical Center Virus Research Center.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tohoku University School of Medicine Ethics Review Committee
Address	1-2 Seiryocho, Aoba-ku, Sendai
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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	仙台医療センター(宮城県)

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 26 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	2019 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2023 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study design. Longitudinal observational study. This study investigates changes in cough reflexes,cough impulses,and coughre leased virus levels over time due to inf luenza infection. Research subjects. Cohort senior citizens who are deemed suitable for subjects in medical facilities. Measurement item. Cough reflex caused by citric acid inhalation. Presence or absence of cough impulse. Number of viruses in cough. Functional Independence Measure. Grip strength.

Management information
Registered date	2019 Year 09 Month 25 Day
Last modified on	2019 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043401