UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the cutoff value of exhaled nitric oxide (eNO) for prediction of asthma control levels
Title of the study (Brief title)	Study on the cutoff value of exhaled nitric oxide (eNO) for prediction of asthma control levels
Region	Japan

Condition
Condition	bronchial asthma
Classification by specialty	Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify that eNO could give an indication of asthma control levels among the patients of adult asthma, and to calculate cutoff value of eNO as an index of asthma control levels.
Basic objectives2	Others
Basic objectives -Others	cutoff value of eNO as an index of asthma control levels
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. eNO (exhaled nitric oxide) 2. Asthma control levels (well-controlled / poor-controlled; determined by indices as below) -%FEV1.0 (forced expiratory volume in 1 second percentage) -Score of ACQ(Asthma Control Questionnaire) -Volatility of PEF (peak expiratory flow)
Key secondary outcomes	Frequency in use of short-acting beta2-agonist(SABA)

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	20 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients(age 20 years or over) diagnosed with bronchial asthma 2)Patients who have been treated by inhaled corticosteroids for the past four weeks or more 3)Patients with written informed consent
Key exclusion criteria	Patients with any of the following conditions are excluded: 1) Visited emergency room or were hospitalized due to exacerbation of asthma within 30 days prior to enrollment. 2) Treated with systemic corticosteroids within 30 days prior to enrollment. 3) Acquiring upper/lower respiratory tract infection within 30 days prior to enrollment. 4) Using inhaled corticosteroids solely or with long-acting beta2-agonists (LABAs) at a dosage that exceeds the approved one. 5) Complicating pulmonary diseases as follows: COPD, bronchiectasis, primary pulmonary cancer, connective tissue disease, pulmonary hypertension, and/or cystic disease of the lungs 6) Current smokers
Target sample size	300

Research contact person
Name of lead principal investigator	Mitsuru Adachi
Organization	Showa University
Division name	The Division of Respiratory and Allergy, Department of Internal Medicine
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555
TEL	06-4706-3315
Email	arai@mcp.co.jp

Public contact
Name of contact person	Masamitsu Arai
Organization	MC&P Co., Ltd.
Division name	Medical Sciences Marketing Division
Address	2-2-2 Nakanoshima, Kita-ku, Osaka, Japan
TEL	06-4716-3315
Homepage URL
Email	ESCORT@mcp.co.jp

Sponsor
Institute	Showa University
Institute
Department

Funding Source
Organization	Advanced Clinical Research Organization
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2009 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 11 Month 24 Day
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date	2009 Year 06 Month 01 Day
Date of closure to data entry	2009 Year 08 Month 01 Day
Date trial data considered complete	2009 Year 09 Month 01 Day
Date analysis concluded	2009 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Cross-sectional study

Management information
Registered date	2009 Year 07 Month 28 Day
Last modified on	2017 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002770