Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Beclometasone/Formoterol/Glycopyrronium treatment group:None
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged >= 18 years with a documented diagnosis of chronic obstructive pulmonary disease (COPD); 2. Patients for whom Beclometasone/Formoterol/Glycopyrronium Inhalation Aerosol is first prescribed and who plan to initiate treatment at Visit 1 (Week 0, V1/W0); 3. Patients who fully understand and have signed the Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: 1.Patients who have experienced moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations within 6 weeks prior to signing the ICF; 2.Patients with poor compliance, who in the investigator's judgment are unable to complete the Visit 5 (Week 24, V5/W24) visit; 3.Patients who have participated in an interventional clinical trial within 6 weeks prior to receiving Beclometasone/Formoterol/Glycopyrronium Inhalation Aerosol; 4.Patients who have previously received additional treatments for COPD other than inhaled therapies, such as biologics (e.g., dupilumab, mepolizumab) or phosphodiesterase (PDE) 3/4 inhibitors (e.g., ensifentrine, roflumilast); 5. Pregnant or breastfeeding women; 6.Patients with known or suspected hypersensitivity to any component of Beclometasone/Formoterol/Glycopyrronium Inhalation Aerosol, such as beclometasone dipropionate, formoterol fumarate, glycopyrronium bromide, or other excipients; 7.Patients assessed by the investigator as having other lung diseases (e.g., lung cancer, pulmonary fibrosis, cystic fibrosis, bronchiectasis) and deemed unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absolute change from baseline in pre-bronchodilator FEV1 at Week 24 of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in FEV1 at Week 24 for patients with different treatment regimens at baseline.;Change from baseline in the annual acute exacerbation rate at Weeks 24 and 52 of treatment.;Change from baseline in CAT score at Weeks 4, 12, 18, 24, 40, and 52 of treatment.;Proportion of patients with a reduction of >=2 points in CAT score from baseline at Weeks 4, 12, 18, 24, 40, and 52 of treatment.;Changes from baseline in FEV1/FVC, RV, RV/TLC, and IC at Weeks 12, 24, and 52 of treatment.;The absolute change from baseline in FEV1 at Weeks 12 and 52 of treatment.;The investigator's assessment of the reason for initiating Beclometasone/Formoterol/Glycopyrronium Inhalation Aerosol at Week 0.;Proportion of patients with SAD at baseline.;Disease burden in patients with SAD at baseline, including baseline CAT score, baseline FEV1, and history of acute exacerbations.;Differences in disease burden between patients with and without SAD at baseline, including baseline CAT score, baseline FEV1, and history of acute exacerbations.;Differences in efficacy at Weeks 24 and 52 of treatment between patients with or without improvement in the SAD indicator (MMEF) relative to baseline.;Changes from baseline in MMEF, FEF50%, and FEF75% at Weeks 12, 24, and 52 of treatment.;Changes from baseline in R5-R20 and Fres at Weeks 12, 24, and 52 of treatment (if the sample size meets statistical requirements).;Changes from baseline in FeNO/CaNO at Weeks 12, 24, and 52 of treatment (if the sample size meets statistical requirements).;Baseline characteristics of patients treated with Beclometasone/Formoterol/Glycopyrronium Inhalation Aerosol.; | — |
Countries
China
Contacts
Public ContactSun Yongchang
Peking University Third Hospital
Outcome results
None listed