UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of relationships between swallowing function and prognostic factors in patients with chronic obstructive pulmonary disease
Acronym	Evaluation of relationships between swallowing function and prognostic factors in patients with chronic obstructive pulmonary disease
Scientific Title	Evaluation of relationships between swallowing function and prognostic factors in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym	Evaluation of relationships between swallowing function and prognostic factors in patients with chronic obstructive pulmonary disease
Region	Japan

Condition
Condition	Chronic Obstructive Pulmonary Disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate swallowing function in patients with chronic obstructive pulmonary disease (COPD) and prospectively study the relationships between swallowing function and prognostic factors.
Basic objectives2	Others
Basic objectives -Others	We evaluate swallowing function during eating property-adjusted test foods and during sleep in patients with COPD, and prospectively study the relationships between swallowing function and prognostic factors such as exacerbation, decline of lung function, and progression of emphysema based on CT images.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Exacerbation, decline of lung function, and progression of emphysema based on CT images within one year categorized by swallowing function at the start point
Key secondary outcomes	Relationship between COPD staging and swallowing function

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients whose FEV1.0% is less than 70%, or clinically diagnosed as emphysema or chronic bronchitis 2. Smoking: 20 pack-year or greater 3. Patients who use diaries to record daily symptoms
Key exclusion criteria	1. Patients whose primary symptom is associated with bronchial asthma 2. Patients with malignant neoplasms or having histories of malignant diseases within 5 years 3. Patients with cerebrovascular diseases or having histories of cerebrovascular diseases 4. Patients having histories of aspiration pneumonia within 2 years 5. Patients taking dopaminergic drugs or ACE inhibitors 6. Patients treated with cardiac pacemakers 7. Patients with apparent dementia (MMSE < 20) 8. Patients who have difficulties in conducting spirometry 9. Patients who declined to participate in the study 10. Patients who were judged as inappropriate to be enrolled by the doctor in charge
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shigeo Muro
Organization	Kyoto university
Division name	Respiratory Medicine
Zip code
Address	54Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL	+81-75-751-3830
Email	smuro@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shigeo Muro
Organization	Kyoto university
Division name	Respiratory Medicine
Zip code
Address	54Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL	+81-75-751-3830
Homepage URL
Email	smuro@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital Clinical Research Center for Medical Equipment Development
Institute
Department

Funding Source
Organization	J Craft Co.
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
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	2014 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	https://bmjopenrespres.bmj.com/content/4/1/e000202
Number of participants that the trial has enrolled
Results	Breathing-swallowing discoordination is strongly associated with frequent exacerbations of COPD. Strategies that identify and improve breathing-swallowing coordination may be a new therapeutic treatment for patients with COPD.
Results date posted	2019 Year 10 Month 19 Day
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	No longer recruiting
Date of protocol fixation	2014 Year 04 Month 14 Day
Date of IRB	2014 Year 07 Month 01 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Swallowing states during adjusted test foods eating and sleep in COPD patients are monitored using a non-invasive swallowing activity monitoring and analysis system that recognizes swallowing and assesses swallowing function by analyzing relationships among swallowing sound, laryngeal motion, and respiration.

Management information
Registered date	2014 Year 05 Month 01 Day
Last modified on	2019 Year 10 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016152

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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