UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of index for the diagnosis of asthma
Title of the study (Brief title)	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	Hironori Sagara
Organization	Dokkyo Medical University Koshigaya Hospital
Division name	Department of Respiratory Medicine
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	Kazuo Hirono
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	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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 01 Month 23 Day
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

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 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