UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002159 |
|---|---|
| Receipt number | R000002638 |
| Scientific Title | Evaluation of index for the diagnosis of asthma |
| Date of disclosure of the study information | 2009/07/03 |
| Last modified on | 2017/06/08 19:33:50 |
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Basic information
Public title
Evaluation of index for the diagnosis of asthma
Acronym
Evaluation of index for the diagnosis of asthma
Scientific Title
Evaluation of index for the diagnosis of asthma
Scientific Title:Acronym
Evaluation of index for the diagnosis of asthma
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic indices of spirometry, eNO (exhaled nitric oxide), several serum biomarkers, and IPAG Adult Asthma Questionnaire for patients with suspected asthma.
Basic objectives2
Others
Basic objectives -Others
Utility of diagnostic indices
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following parameter of each index for the diagnosis of asthma;
1) Sensitivity(%) and Specificity(%)
2) PPV(Positive Predictive Value:%), NPV(Negative Predictive Value:%)
3) ROC curve (Receiver-Operator Characteristic curve)
4) Area under the ROC curve
Key secondary outcomes
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) Patient who has never been diagnosed as asthma
2) Patient who had either of cough, wheezing, breathing difficulties, or sputum for the past three weeks or more
3) Man and woman of 20 years old or more
4) Patient who signs the letter of consent
Key exclusion criteria
1) Patient who used anti-inflammatory drugs (oral/inhaled/nasal steroid, leukotriene receptor antagonist, chemical mediator release inhibitor, Th2 cytokine inhibitor, or slow-release theophylline) within the past four weeks
2) Patient who was affected with respiratory tract infection within the past three weeks
3) Patient with a history of asthma
4) Patient with breast abnormality detected by a chest X-ray
5) Patient who occurs with the following pulmonary diseases: bronchiectasis, primary pulmonary cancer, connective tissue disease, pulmonary hypertension, and/or cystic disease of the lungs
6) Patient who smoked within the past year
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironori Sagara |
Organization
Dokkyo Medical University Koshigaya Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-1-50 Minamikoshigaya, Koshigaya, Saitama 343-8555, Japan
TEL
06-4706-3315
arai@mcp.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Hirono |
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
IAA@mcp.co.jp
Sponsor or person
Institute
Dokkyo Medical University Koshigaya Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Allergy Foundation
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 | 07 | 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
| 2008 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross-sectional study
Management information
Registered date
| 2009 | Year | 07 | Month | 02 | 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=R000002638
| 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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| Registered date | File name |
