UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010509
Receipt number R000012278
Scientific Title The role of hydrogen sulfide (H2S) as a marker of diagnosis and control in respiratory diseases
Date of disclosure of the study information 2013/06/11
Last modified on 2022/11/14 14:31:31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The role of hydrogen sulfide (H2S) as a marker of diagnosis and control in respiratory diseases

Acronym

Relationship between hydrogen sulfide and respiratory diseases

Scientific Title

The role of hydrogen sulfide (H2S) as a marker of diagnosis and control in respiratory diseases

Scientific Title:Acronym

Relationship between hydrogen sulfide and respiratory diseases

Region

Japan


Condition

Condition

- Bronchial asthma
- Chronic obstructive pulmonary disease
- Interstitial pneumonia
- Bacterial pneumonia
- Lung tuberculosis
- Healthy volunteer

Classification by specialty

Pneumology Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the study is to investigate whether hydrogen sulfide in serum, sputum, saliva, urine, exhaled breath as a new biomarker for diagnosis and control of respirtory diseases.

Basic objectives2

Others

Basic objectives -Others

Hydrogen sulfide levels in various respiratory diseases are measured using serum, sputum, saliva, urine, and exhaled breath. In addition, the time course of the hydrogen sulfide levels are also evaluated.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

To compare the hydrogen sulfide levels in various respiratory diseases.

Key secondary outcomes

1. To investigate the relationships between hydrogen sulfide levels and other conventional parameters such as pulmonary function, fractional exhaled nitric oxide (FeNO), St Georges Repiratory Questionnaire (SGRQ), and inflammatory cells in sputum.
2. To evaluate the relationships between the time course of hydrogen sulfide levels, severity and state of respiratory diseases.


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

18 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with respiratory diseases shown below at the outpatient clinc or in the hospital of Fukushima Medical University.
- Bronchial asthma
- Chronic obstructive pulmonary disease
- Interstitial pneumonia
- Bacterial pneumoina
- Lung tuberculosis
In addition, healthy volunteer with or without smoking

Key exclusion criteria

1. Patients with an indefinite diagnosis
2. Patients having severe complications
3. Pregnant women or breast feeding women
4. Patients who are unable to give informed consent
5. Inappropriate patients judged by respiratory physicians

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Junpei
Middle name
Last name Saito

Organization

Fukushima Medical University, School of Medicine

Division name

Department of Pulmonary Medicine

Zip code

960-1295

Address

1 Hikarigaoka, Fukushima

TEL

08045151971

Email

junpei@fmu.ac.jp


Public contact

Name of contact person

1st name Junpei
Middle name
Last name Saito

Organization

Fukushima Medical Univercity, School of Medicine

Division name

Department of Pulmonary Medicine

Zip code

960-1295

Address

1 Hikarigaoka, Fukushima

TEL

024-548-2111

Homepage URL


Email

pulmo@fmu.ac.jp


Sponsor or person

Institute

Department of Pulmonary Medicine, Fukushima Medical University, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Pulmonary Medicine, Fukushima Medical University, School of Medicine

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

Ethic

Address

1 Hikarigaoka

Tel

08045151971

Email

fmucrb@fmu.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

福島県立医科大学医学部付属病院


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 11 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

Open public recruiting

Date of protocol fixation

2013 Year 04 Month 17 Day

Date of IRB

2013 Year 06 Month 01 Day

Anticipated trial start date

2013 Year 06 Month 11 Day

Last follow-up date

2023 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Hydrogen sulfide levels are measured in various respiratory diseases such as bronchial asthma, COPD, interstitial pneumonia, bacterial pneumonia and tuberculosis.


Management information

Registered date

2013 Year 04 Month 16 Day

Last modified on

2022 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012278


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name