UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021726
Receipt number R000025060
Scientific Title Influences of hiatus hernia on exacerbation in COPD patinets
Date of disclosure of the study information 2016/03/31
Last modified on 2022/07/03 21:57:20

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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 or person

Institute

hitachnaka general hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025060