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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021675
Receipt No. R000024997
Scientific Title Analysis of swallwoing function in chronic obstructive pulmonary diseases using videofluoroscopic examination of swallowing
Date of disclosure of the study information 2016/03/30
Last modified on 2016/03/31

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Basic information
Public title Analysis of swallwoing function in chronic obstructive pulmonary diseases using videofluoroscopic examination of swallowing
Acronym Analysis of swallwoing function in (COPD) using videofluoroscopic examination
Scientific Title Analysis of swallwoing function in chronic obstructive pulmonary diseases using videofluoroscopic examination of swallowing
Scientific Title:Acronym Analysis of swallwoing function in (COPD) using videofluoroscopic examination
Region
Japan

Condition
Condition chronic obstructive pulmonary disease
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the swallowing function in patinets with COPD
Basic objectives2 Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes swallowing function, swallowing reflex, pooling finding in VF examination, time of swallowing completion, aspiration frequency
Key secondary outcomes analysis of aspiration, acute exacerbation frequency, prognosis, eating ability, nutriotion state

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
40 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Clinically stable patients with moderate to severe COPD,who are 40 years of age or older and have smoking history or current smokers and stop smoking at the time of giving the consent to this study..
They all provide written, informed consent.
Key exclusion criteria Exclusion criteria: (1) Coexistence of other major pulmonary diseases such as asthma, bronchiectasis, pulmonary fibrosis, tuberculosis, and pulmonary cancer diagnosed by imaging modalities and/or laboratory findings. Asthma is excluded based on clinical history and/or laboratory findings, including levels of IgE and/or eosinophils in blood and/or sputum, but not based on reversibility of airflow limitation.
(2)patients with cancers
(3)patients with other serious complocations
(4) Those who are considered as inappropriate subjects for any reasons.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Teramoto
Organization Hitachinaka General Hospital
Division name Department of Pulmonary Medicine
Zip code
Address 20-1 Ishikawa-cho, Hitachinaka-shi, Ibaraki,Japan 312-0057
TEL 029-354-5111
Email shinjit-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Teramoto
Organization Hitachinaka General Hospital
Division name Department of Pulmonary Medicine
Zip code
Address 20-1 Ishikawa-cho, Hitachinaka-shi, Ibaraki,Japan 312-0057
TEL 029-354-5111
Homepage URL
Email shinjit-tky@umin.ac.jp

Sponsor
Institute Hitachinaka General Hospital
Institute
Department

Funding Source
Organization Hitachinaka General 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
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 03 Month 30 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 Enrolling by invitation
Date of protocol fixation
2016 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 30 Day
Last follow-up date
2018 Year 03 Month 30 Day
Date of closure to data entry
2018 Year 03 Month 30 Day
Date trial data considered complete
2018 Year 03 Month 30 Day
Date analysis concluded
2018 Year 03 Month 30 Day

Other
Other related information none

Management information
Registered date
2016 Year 03 Month 30 Day
Last modified on
2016 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024997

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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