Asthma, chronic obstructive pulmonary disease (COPD), emphysema, chronic bronchitis
Conditions
Interventions
None listed
Sponsors
Department of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Hokkaido Research Institute for Respiratory Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects will be recruited from patients with asthma*, COPD, emphysema**, or chronic bronchitis*** who have been seen or will be seen by respiratory specialists in the participating community hospitals. * Patients with cough variant asthma should be excluded. ** Emphysema should be diagnosed by the presence of low-attenuation area by CT scan. *** Chronic bronchitis should be diagnosed by the presence of productive cough that lasts for three months or more per year for at least two years. Key inclusion criteria (phase I) 1. Clinically stable subjects who do not experience exacerbations requiring prescription change within 30 days before informed consent 2. Age 55 year-old or older 3. Subjects who agree to participate in this study with written informed consent Key inclusion criteria for detailed examinations (phase II, suspicious of ACOS) 1. Clinically stable subjects with airflow limitation (pre-bronchodilator FEV1/FVC < 0.70) under appropriate therapy and/or emphysema on CT scan at some time during the history 2. Having any of following criteria (at least one item) A. At least one pattern of symptoms at some time during the history a. Variation over minutes, hours, or days b. Worse during the night or early morning c. Triggered by exercise, emotions including laughter, dust, or exposure to allergens B. Diagnosis of asthma by a respiratory specialist at some time during the history or at the time of informed consent C. Eosinophil count in peripheral blood >= 300 cells / mm3 in the past D. Increased response to bronchodilator: FEV1 increase >= 200 ml and >= 12% in the past E. Positive specific IgE for any of inhaled antigen or total IgE > 100 IU in the past 3. Subjects who agree with detailed examinations at Hokkaido University Hospital
Exclusion criteria
Exclusion criteria: 1. Any kind of active respiratory infections including tuberculosis 2. Thoracic deformity which would influence pulmonary function tests 3. Any kind of malignant diseases in whom 3 year's follow-up would not be possible 4. History of lung resection 5. Any kind of pulmonary diseases including cystic fibrosis (CF), non-CF bronchiectasis, hypersensitivity pneumonitis, pulmonary fibrosis, secondary bronchiolitis obliterans, and others 6. Difficulty in performing pulmonary function tests due to dementia or other serious diseases 7. Deficient in alpha-1 antitrypsin 8. Judged to be inappropriate subjects for any reasons by principle investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Moderate and severe exacerbation* free period and its frequency and annual change in FEV1 during the follow-up period based on clinical phenotypes of ACOS characterized by cluster analysis using clinical, physiological, and radiological parameters * Exacerbation will be defined as an acute event characterized by a worsening of the patient's respiratory symptoms (at least two of the symptoms of increased dyspnea, change in sputum purulence or increased sputum volume, increased cough, wheezing, or chest tightness) that is beyond day-to-day variations. Moderate exacerbation will be defined as new prescription of antibiotics and/or systemic corticosteroids due to exacerbation. Severe exacerbation will be defined as emergency room visit and/or admission due to exacerbation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prevalence rate of ACOS among patients with chronic airways disease in older adults 2. Longitudinal change and comparison among each clinical phenotype of ACOS and non-ACOS (only variables with *) of the following variables A. Pulmonary function test (pre- and post-bronchodilator spirometry and diffusion capacity)* B. Assessment of disease control level by ACT and CAT* C. Assessment of quality of life by AQLQ and SGRQ D. Level of exhaled nitric oxide* E. Frequency of reliever drug use* F. Treatment* G. Adherence to medications* H. Comorbidities* I. Analysis of body composition J. Three-dementional CT analysis of airways and lung parenchyma 3. Overall survival 4. CT analysis of sinusitis and visceral fat 5. Assessment of biological markers in serum, plasma, urine, and sputum - Complete blood count - Inflammatory cytokines - Adipokines - Metabolome 6. Analysis of genetic polymorphisms - Beta2-adrenergic receptor (ADRB2) polymorphism - Other genetic polymorphisms of biomarker candidates 7. Assessment of gene expression of airway epithelial cells collected by bronchoscopy - mRNA microarray - microRNA microarray 8. Pathological analysis of airway biopsy samples 9. Assessment of exosomal microRNA expression in peripheral blood | — |
Countries
Japan
Contacts
Public ContactMasaru Suzuki
Faculty of Medicine and Graduate School of Medicine, Hokkaido University Department of Respiratory Medicine
Outcome results
None listed