UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010675
Receipt number R000012481
Scientific Title The clinical usefulness of fractional exhaled nitric oxide (FeNO) as a marker of asthma control
Date of disclosure of the study information 2013/06/11
Last modified on 2022/11/14 14:26:46

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Basic information

Public title

The clinical usefulness of fractional exhaled nitric oxide (FeNO) as a marker of asthma control

Acronym

Asthma control using fractional exhaled nitric oxide (FeNO)

Scientific Title

The clinical usefulness of fractional exhaled nitric oxide (FeNO) as a marker of asthma control

Scientific Title:Acronym

Asthma control using fractional exhaled nitric oxide (FeNO)

Region

Japan


Condition

Condition

- Bronchial asthma with no treatment
- Healthy non-smoker

Classification by specialty

Pneumology Clinical immunology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the study is to observe the timecourse of FeNO levels in asthmatic subjects.

Basic objectives2

Others

Basic objectives -Others

Daily FeNO measurements will be perfoemed to see whether there is a day-to-day, or week-to-week fluctuation in FeNO levels in asthmatic subjects before and after asthma treatment.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

To compare diurnal variations and week-to-week variations of FeNO levels in asthmatic subjects before and after asthma treatment

Key secondary outcomes

To compare whether there are diurnal and week-to-week variations of FeNO levels in asthmatic subjects when they are devided into controlled and uncontrolled state.


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

Asthmatic patients at the outpatient clinic at Fukushima Medical University Hospital who have not yet been treated for asthma.
In addition, healthy non-smoking volunteers

Key exclusion criteria

1. Patients with respiratory diseases other than asthma.
2. Pregnant women or breast feeding women
3. Patients who are unable to give informed consent.
4. Inappropriate patients judged by respiratory physician.

Target sample size

70


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 city, Fukushima Prefecture

TEL

08045151971

Email

junpei@fmu.ac.jp


Public contact

Name of contact person

1st name Junpei
Middle name
Last name Saito

Organization

Doctor

Division name

Department of Pulmonary Medicine

Zip code

960-1295

Address

1 Hikarigaoka, Fukushima city, Fukushima Prefecture

TEL

08045151971

Homepage URL


Email

junpei@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

Ethics committee of Fukushima Medical Uiversity

Address

1 Hikarigaoka, Fukushima city, Fukushima, Japan

Tel

024- 547-1825

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

Completed

Date of protocol fixation

2013 Year 05 Month 09 Day

Date of IRB

2013 Year 06 Month 01 Day

Anticipated trial start date

2013 Year 06 Month 12 Day

Last follow-up date

2022 Year 01 Month 31 Day

Date of closure to data entry

2022 Year 01 Month 31 Day

Date trial data considered complete

2022 Year 01 Month 31 Day

Date analysis concluded

2023 Year 01 Month 31 Day


Other

Other related information

Daily FeNO measurements will be perfoemed to see whether there is a day-to-day, or week-to-week fluctuation in FeNO levels in asthmatic subjects before and after asthma treatment.


Management information

Registered date

2013 Year 05 Month 08 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=R000012481


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name