UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003254 |
|---|---|
| Receipt number | 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 18:33:43 |
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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
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
hiro@hokkaido.med.or.jp
Sponsor or person
Institute
Division of Respiratory Medicine, Department of Internal Medicine, Hokkaido University Graduate School of Medicine
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003917
