COPD
Conditions
Keywords
Lysozyme hydrochloride, COPD
Brief summary
The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.
Interventions
DRUGLysozyme hydrochloride
LYL 90mg capsule: Three times daily for 52 weeks.
DRUGPlacebo
Matching Placebo capsule: Three times daily for 52 weeks.
Sponsors
Eisai Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
; * Patients were eligible for inclusion in the study if they were over 20 years of age and below 85 years of age, and had a smoking history, a diagnosis of COPD, a ratio of FEV1 to forced vital capacity(FVC) of less than 70%, and a documented history of at least one exacerbation leading to any treatment within the previous year.
Exclusion criteria
; * Patients with egg allergy * Patients with domiciliary oxygen therapy * Patients with pneumonia or pulmonary tuberculosis * Patients with severe cardiovascular disorder,severe kidney disorder, severe hepatic disorder, severe hematological disorder. * Patients with cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute exacerbation of COPD | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Yearly reduction in FEV1 and QOL assessed by CAT | 52 weeks |
Countries
Japan
Outcome results
None listed