UMIN-CTR Clinical Trial

Basic information
Public title	Influences of hiatus hernia on exacerbation in COPD patinets
Acronym	Influences of hiatus hernia on exacerbation in COPD patinets
Scientific Title	Influences of hiatus hernia on exacerbation in COPD patinets
Scientific Title:Acronym	Influences of hiatus hernia on exacerbation in COPD patinets
Region	Japan

Condition
Condition	COPD,hiatus hernia
Classification by specialty	Pneumology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the co-existence of hiatus hernia (HH) on the frequency of exacerbation in COPD patients
Basic objectives2	Others
Basic objectives -Others	association between the frequency of AECOPD and the presence of HH or GERD
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The frequency of exacerbation in COPD patients
Key secondary outcomes

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	100 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. The patents are with or without hiatus hernia. They all provide written, informed consent.
Key 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 Shinji Middle name Last name Teramoto
Organization	Hitachinaka General Hospital
Division name	Department of pulmonary medicine
Zip code	312-0057
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 Shinji Middle name Last name Teramoto
Organization	Hitachinaka General Hospital
Division name	Department of pulmonary medicine
Zip code	312-0057
Address	20-1 Ishikawa-cho Hitachinaka-shi
TEL	029-354-5111
Homepage URL
Email	shinjit-tky@umin.ac.jp

Sponsor
Institute	hitachnaka general hospital
Institute
Department

Funding Source
Organization	hitachnaka 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	Hitachinaka general Hospital
Address	20-1 ishikawa-cho Hitachinaka-shi Ibaraki
Tel	029-354-5111
Email	shinjit-tky@umin.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

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 31 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	2014 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2017 Year 04 Month 01 Day
Date of closure to data entry	2017 Year 04 Month 01 Day
Date trial data considered complete	2017 Year 04 Month 01 Day
Date analysis concluded	2017 Year 05 Month 29 Day

Other
Other related information	The results will be presented in the Journals.

Management information
Registered date	2016 Year 03 Month 31 Day
Last modified on	2022 Year 07 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025060