UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational cohort study in patients with severe asthma based on clinical phenotypes
Title of the study (Brief title)	Hokkaido-based Investigative Cohort Analysis for Refractory Asthma (Hi-CARAT)
Region	Japan

Condition
Condition	Bronchial asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To define phenotypes of severe asthma based on clinical, physiological, and radiological findings To prospectively evaluate natural course of severe asthma based on clinical phenotypes
Basic objectives2	Others
Basic objectives -Others	Observational cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Longitudinal changes and fluctuations in forced expiratory volume in 1 second (FEV1) and peak expiratory flow (PEF) over 6 years at the most, based on clinical phenotypes.
Key secondary outcomes	A) Evaluation and characterization of clinical, physiological, and radiological findings in patients with severe asthma B) Characteristics of those patients based on clinical phenotypes C)Longitudinal change of the following variables 1.Number of exacerbation, exacerbation free period 2.Frequency of reliever drug use 3.Assessment of control level by ACT 4.Assessment of QOL by AQLQ 5.Level of exhaled nitric oxide 6.Treatment 7.Adherence to medications 8.Symptoms due to co-morbidities D) Airway analysis by 3-dementional CT E) Genetic association with the development of severe asthma F) Assessment of markers in serum, urine, and sputum G) Co-morbidities H) Risk factors for the development of severe asthma (Evaluation of control subjects do not necessarily include all of the above-mentioned outcome measurements.)

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with severe asthma diagnosed by respiratory physicians based on the ATS criteria of refractory asthma (Dose of ICS is defined by own criteria) (Control subjects should be patients with milder asthma who do not qualify for the above-mentioned criteria.)
Key exclusion criteria	1. Patients with any kind of active respiratory infections, including tuberculosis 2. Patients with thoracic deformity which would influence pulmonary function tests 3. Patients with any kind of malignant diseases in whom 3 years' follow-up would not be possible 4. Patients with history of lung resection 5. Patients with any kind of serious pulmonary diseases, including cystic fibrosis, hypersensitivity pneumonitis, pulmonary fibrosis and others 6. Patients who have difficulty in performing pulmonary function tests due to dementia and others 7. Patients with serious heart diseases 8. Patients who are judged to be inappropriate subjects for any reasons by principal investigators
Target sample size	300

Research contact person
Name of lead principal investigator	Masaharu Nishimura
Organization	Hokkaido University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Address	North 15, West 7, Kitaku, Sapporo, 060-8638
TEL	011-706-5911
Email	ma-nishi@med.hokudai.ac.jp

Public contact
Name of contact person	Hironi Makita
Organization	Cohort Study Institute on Respiratory Diseases
Division name	Division of Bronchial Asthma
Address	5F, Housui Medical Clinic Building, South 7, West 2, Chuou-ku, Sapporo,064--0807, Japan
TEL	011-207-6771
Homepage URL
Email	hiro@hokkaido.med.or.jp

Sponsor
Institute	Division of Respiratory Medicine, Department of Internal Medicine, Hokkaido University Graduate School of Medicine
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	北海道大学病院（北海道）

Other administrative information
Date of disclosure of the study information	2010 Year 02 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 01 Month 06 Day
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date	2018 Year 10 Month 31 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	Prospective observation study. Register the patients who meet registration criteria, and follow their clinical course for 6 years at the most.

Management information
Registered date	2010 Year 02 Month 24 Day
Last modified on	2019 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003917