UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of swallwoing function in chronic obstructive pulmonary diseases using videofluoroscopic examination of swallowing
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shinji Teramoto
Organization	Hitachinaka General Hospital
Division name	Department of Pulmonary Medicine
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	Shinji Teramoto
Organization	Hitachinaka General Hospital
Division name	Department of Pulmonary Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 03 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/ctr_e/ctr_view.cgi?recptno=R000024997