UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002263
Receipt No. R000002770
Scientific Title Study on the cutoff value of exhaled nitric oxide (eNO) for prediction of asthma control levels
Date of disclosure of the study information 2009/08/01
Last modified on 2017/06/08

* 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 Study on the cutoff value of exhaled nitric oxide (eNO) for prediction of asthma control levels
Acronym Study on the cutoff value of exhaled nitric oxide (eNO) for prediction of asthma control levels
Scientific Title Study on the cutoff value of exhaled nitric oxide (eNO) for prediction of asthma control levels
Scientific Title:Acronym 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
1st name
Middle name
Last name Mitsuru Adachi
Organization Showa University
Division name The Division of Respiratory and Allergy, Department of Internal Medicine
Zip code
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
1st name
Middle name
Last name Masamitsu Arai
Organization MC&P Co., Ltd.
Division name Medical Sciences Marketing Division
Zip code
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)

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
2009 Year 08 Month 01 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
2008 Year 11 Month 24 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.