chronic obstructive pulmonary disease
Conditions
Interventions
Transition from 12 months of LAMA/LABA treatment to 12 months of ICS/LAMA/LABA treatment.
Transition from 12 months of ICS/LAMA/LABA treatment to 12 months of LAMA/LABA treatment.
Sponsors
Nippon Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: On or after July 5, 2022 1. Patients aged 40 and older (both genders) 2. Patients diagnosed with COPD without other coexisting lung diseases at the Department of Respiratory Medicine of Nippon Medical School Hospital or the Respiratory Care Clinic of Nippon Medical School, who are starting either LAMA/LABA treatment or ICS/LAMA/LABA treatment. Patients who are not expected to require a change in their treatment plan after more than three months of LAMA/LABA treatment or ICS/LAMA/LABA treatment. Patients who are either current or former smokers, with a lung function FEV1/FVC (forced expiratory volume in one second/forced vital capacity) ratio of <70% and no other diseases associated with airflow obstruction apart from COPD. Patients who have been provided with an informed consent document and have given consent to participate in this study.
Exclusion criteria
Exclusion criteria: "Patients with a history of bronchial asthma. Patients with an increase in FEV1 (forced expiratory volume in one second) of 200 ml or more before and after inhalation of short-acting bronchodilators (400 mcg salbutamol). Patients with peripheral blood eosinophil counts of 300 cells/uL or more. Patients with asthma-like symptoms believed to be due to allergic factors. Patients with a recorded serum IgE level exceeding 170 IU/mL. Patients already on LAMA, LABA, or ICS therapy outside of this study. Patients with conditions causing respiratory symptoms other than COPD, such as heart disease leading to congestion. Patients with angle-closure glaucoma. Patients with urinary disturbances due to conditions such as prostatic hypertrophy. Patients with infections for which there are no effective antibiotics or patients with deep-seated fungal infections. Other patients deemed unsuitable for participation in this study by the principal investigator or co-investigators."
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Temporal changes in IOS (impulse oscillometry system) over a period of one year, including R5 (respiratory system resistance values at 5 Hz) as an index of total airway resistance, R20 (respiratory system resistance values at 20 Hz) as an index of central airway resistance, X5 (reactance at 5 Hz) as an index of frequency-dependent resistance, and Fres (frequency of resonance) as an index of airway resistance components. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in assessment items commonly used for observing the clinical course of COPD, such as lung function tests and clinical symptoms, before and after LAMA/LABA therapy and ICS/LAMA/LABA therapy. | — |
Countries
Japan
Contacts
Public ContactYosuke Tanaka
Nippon Medical School Department of Respiratory Mdedicine
Outcome results
None listed