UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013861 |
|---|---|
| Receipt number | R000016152 |
| Scientific Title | Evaluation of relationships between swallowing function and prognostic factors in patients with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2023/11/07 09:42:03 |
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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
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
smuro@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital Clinical Research Center for Medical Equipment Development
Institute
Department
Personal name
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
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
https://bmjopenrespres.bmj.com/content/4/1/e000202
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
65
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
| 2017 | Year | 08 | Month | 01 | Day |
Baseline Characteristics
stable outpatients with COPD. Patients with an apparent swallowing disorder, clinically evident cerebrovascular diseases, dementia or a cardiac pacemaker were excluded.
Participant flow
We evaluated the number of COPD exacerbation incidents from 1 year before and 1 year after the recruitment visit (day 0).
Adverse events
None.
Outcome measures
Coordination between breathing and swallowing, CAT, FSSG, FILS, FOIS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 30 | Day |
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
| 2023 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016152
