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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003254
Receipt No. R000003917
Scientific Title Observational cohort study in patients with severe asthma based on clinical phenotypes
Date of disclosure of the study information 2010/02/25
Last modified on 2019/03/03

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Basic information
Public title Observational cohort study in patients with severe asthma based on clinical phenotypes
Acronym Hokkaido-based Investigative Cohort Analysis for Refractory Asthma (Hi-CARAT)
Scientific Title Observational cohort study in patients with severe asthma based on clinical phenotypes
Scientific Title:Acronym 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
1st name
Middle name
Last name Masaharu Nishimura
Organization Hokkaido University Graduate School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code
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
1st name
Middle name
Last name Hironi Makita
Organization Cohort Study Institute on Respiratory Diseases
Division name Division of Bronchial Asthma
Zip code
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)

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 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

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
2010 Year 01 Month 06 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000003917

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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