UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002263 |
|---|---|
| Receipt number | 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 19:34:50 |
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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
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
ESCORT@mcp.co.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002770
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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