Observational cohort study in patients with severe asthma based on clinical phenotypes

Observational cohort study in patients with severe asthma based on clinical phenotypes - Hokkaido-based Investigative Cohort Analysis for Refractory Asthma (Hi-CARAT)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000003254

Enrollment

300

Registered

2010-02-25

Start date

2010-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial asthma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.)	—

Measure

Time frame

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.)

—

Countries

Japan

Contacts

Public ContactHironi Makita

Cohort Study Institute on Respiratory Diseases Division of Bronchial Asthma

hiro@hokkaido.med.or.jp011-207-6771

Outcome results