UMIN-CTR Clinical Trial

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 Middle name Last name Akihiro Shiroshita
Organization	Kameda Medical Center
Division name	pulmonology
Zip code
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 Middle name Last name Akihiro Shiroshita
Organization	Kameda Medical Center
Division name	pulmonology
Zip code
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
Institute	Department of Pulmonary Medicine, Kameda Medical Center
Institute
Department

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
Address
Tel
Email

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	Open public recruiting
Date of protocol fixation	2018 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date
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	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.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

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