UMIN-CTR Clinical Trial

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

Bronchial asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

YES

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

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.)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Division of Respiratory Medicine, Department of Internal Medicine, Hokkaido University Graduate School of Medicine

Institute

Department

Personal name

Organization

Japan Allergy Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道大学病院（北海道）

Date of disclosure of the study information

2010

Year

02

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Prospective observation study.
Register the patients who meet registration criteria, and follow their clinical course for 6 years at the most.

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