Chronic obstructive pulmonary disease
Conditions
Interventions
Switching from LAMA/LABA treatment to ICS/LAMA/LABA in COPD patients who have been on long-term LAMA/LABA therapy for over one year and still experience symptoms related to COPD.
Sponsors
Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Patients aged 40 years or older (both male and female). 2 Patients diagnosed with COPD without other pulmonary diseases at the Respiratory Medicine Department of Nippon Medical School Hospital or Nippon Medical School Respiratory Care Clinic, who had been receiving LAMA/LABA therapy for more than one year, had not experienced any significant COPD exacerbations in the past year, and had stable but persistent COPD symptoms that allowed for daily home activities. 3 Patients who were expected to not require changes to the treatment regimen of ICS/LAMA/LABA therapy for over one year. 4 Patients who were current or former smokers, with lung function showing respiratory system resistance values at 20 Hz in the inspiratory phase: FEV1% (Forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC)) <70%, and without diseases related to airflow obstruction other than COPD. 5 Patients were informed about the study using an informed consent document and provided consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1 Patients with a history of bronchial asthma. 2 Patients who show an increase in FEV1 of 200 ml or more before and after inhalation of a short-acting bronchodilator (400 mcg salbutamol). 3 Patients with a peripheral blood eosinophil count 300 cells/mcL oe more than 300 cells/mcL. 4 Patients with asthma-like symptoms believed to be due to allergic factors. 5 Patients with serum IgE > 170 IU/mL. 6 Patients who have already been treated with any of the drugs LAMA, LABA, or ICS outside of this study. 7 Patients with diseases that cause respiratory symptoms other than COPD, such as heart disease leading to congestion. 8 Patients with closed-angle glaucoma. 9 Patients with urinary retention due to conditions such as prostate hypertrophy. 10 Patients with infections or deep-seated mycoses for which no effective antimicrobial agents are available. 11 Other patients whom the principal investigator or sub-investigator deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in airway pathology one year after adding ICS to LAMA/LABA therapy, as inferred from the results of airway resistance (both expiratory and inspiratory resistance) obtained from impulse oscillation system (IOS) using MostGraph and pulmonary function test. | — |
Secondary
| Measure | Time frame |
|---|---|
| modified Medical Research Council (mMRC) Dyspnea Scale scores and study drug safety. | — |
Countries
Japan
Contacts
Public ContactYosuke Tanaka
Nippon Medical School Department of Pulmonary Medicine and Oncology, Graduate School of Medicine
Outcome results
None listed