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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002159
Receipt No. 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

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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
Email 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
Email IAA@mcp.co.jp

Sponsor
Institute Dokkyo Medical University Koshigaya Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002638

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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