chronic obstructive pulmonary disease
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with COPD who have been receiving triple inhalation therapy with budesonide glycopyrronium formoterol in routine clinical practice for 4 weeks or longer 2.Patients with a COPD Assessment Test CAT score of 10 or higher 3.Adults aged 40 years or older 4.Patients who have provided written informed consent for participation in the study If a patient develops influenza or a similar illness during the observation period the patient will be considered withdrawn however re enrollment is allowed if 4 weeks or more have passed after recovery and the eligibility criteria are met
Exclusion criteria
Exclusion criteria: 1.Patients diagnosed with other respiratory diseases except for those with comorbid asthma 2.Patients with a history of allergy or hypersensitivity to inhaled medications 3.Patients who plan to participate in another study during the study participation period 4.Patients who have experienced an exacerbation within 4 weeks 5.Patients considered ineligible by the investigator due to impaired cognitive function or other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAT scores at baseline and at 4 weeks after spacer use. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients achieving the MCID in CAT score (2 or more point improvement) 2.Pulmonary function at baseline and at 4 weeks after spacer use (%FVC, %FEV1, FEF25-75) 3.IOS parameters at baseline and at 4 weeks after spacer use (R5, R20, X5, Fres) 4.Medication adherence at baseline and at 4 weeks after spacer use (ASK-12) | — |
Countries
Japan
Contacts
Hiroshima Allergy and Respiratory Clinic Hatchobori Chief Medical Director