Observational cohort study in patients with severe asthma based on clinical phenotypes
Not Applicable
- Conditions
- Bronchial asthma
- Registration Number
- JPRN-UMIN000003254
- Lead Sponsor
- Division of Respiratory Medicine, Department of Internal Medicine, Hokkaido University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ongitudinal 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 Outcome Measures
Name Time Method 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.)