UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034005
Receipt number R000038557
Scientific Title Fractional nitric oxide concentration in exhaled breath predicts short term response to high-dose inhaled corticosteroid treatment: a single centered pre-post study
Date of disclosure of the study information 2018/09/03
Last modified on 2020/03/05 23:38:30

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Basic information

Public title

Fractional nitric oxide concentration in exhaled breath predicts short term response to high-dose inhaled corticosteroid treatment: a single centered pre-post study

Acronym

Fractional nitric oxide concentration in exhaled breath predicts short term response to high-dose inhaled corticosteroid treatment: a single centered pre-post study

Scientific Title

Fractional nitric oxide concentration in exhaled breath predicts short term response to high-dose inhaled corticosteroid treatment: a single centered pre-post study

Scientific Title:Acronym

Fractional nitric oxide concentration in exhaled breath predicts short term response to high-dose inhaled corticosteroid treatment: a single centered pre-post study

Region

Japan


Condition

Condition

COPD

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study will aim to assess the improvement of forced expiratory volume in one second (FEV1) by Inhaled corticosteroid in stable COPD patients with FeNO > 35 ppb.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

The primary outcome is change of post-bronchodilator FEV1 by using high-dose ICS.

Key secondary outcomes

The secondary outcomes are improvement of CAT score, %FEV1, %FVC.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

After enrollment, they made 2 outpatient visits. At visit 1, patients' baseline characteristics will be recorded and subjects will receive budesonide 200 microgram, 8 puffs daily for 28 days. At visit 2, 28 days after the enrollment, post-bronchodilator pulmonary function test will be investigated.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

COPD patients on treatment with LABA, LAMA, LAMA/LABA or none who were more than 40 years and met all of the following criteria will be recruited; current or ex-smokers of more than 10 pack-years, post-bronchodilator FEV1/forced vital capacity (FVC) ratio < 70%, FeNO > 35ppb.

Key exclusion criteria

We will exclude patients taking oral or inhaled corticosteroids within 1 month of trial entry.
We will also exclud unstable COPD patients who have an exacerbation within 6 weeks of trial entry or have severe intercurrent diseases.

Target sample size

23


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Shiroshita

Organization

Kameda Medical Center

Division name

pulmonology

Zip code

2960001

Address

Department of Pulmonary Medicine, Kameda Medical Center, 929 Higashi-cho, Kamogawa, Chiba 296-8602

TEL

+81-4-7092-2211

Email

akihirokun8@gmail.com


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Shiroshita

Organization

Kameda Medical Center

Division name

pulmonology

Zip code

2960001

Address

Department of Pulmonary Medicine, Kameda Medical Center, 929 Higashi-cho, Kamogawa, Chiba 296-8602

TEL

+81-4-7092-2211

Homepage URL


Email

akihirokun8@gmail.com


Sponsor or person

Institute

Department of Pulmonary Medicine, Kameda Medical Center

Institute

Department

Personal name



Funding Source

Organization

Department of Pulmonary Medicine, Kameda Medical Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kameda Medical Center

Address

929 Higashi-cho

Tel

+818038074960

Email

akihirokun8@gmail.com


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

2018 Year 09 Month 03 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

2018 Year 08 Month 10 Day

Date of IRB

2018 Year 10 Month 25 Day

Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date

2019 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 03 Day

Last modified on

2020 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038557


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name