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The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lysozyme hydrochloride | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lysozyme hydrochloride | Drug | LYL 90mg capsule: Three times daily for 52 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Acute exacerbation of COPD | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Yearly reduction in FEV1 and QOL assessed by CAT | 52 weeks |
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Inclusion criteria;
Exclusion criteria;
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| Name | Affiliation | Role |
|---|---|---|
| Yukinori Sakata | Drug Fostering and evolution Coodination Department, Corporate Regulattory Compliance, Safety and Quality Assurance Headquaters, Eisai Co., Ltd., Japan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nishio | Aichi-ken | Japan | ||||
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| Placebo |
| Drug |
Matching Placebo capsule: Three times daily for 52 weeks. |
|
| Noda |
| Chiba |
| Japan |
| Fukuoka | Fukuoka | Japan |
| Kasuga | Fukuoka | Japan |
| Kyoto-gun | Fukuoka | Japan |
| Yanagawa | Fukuoka | Japan |
| Mabashi | Gunma | Japan |
| Takasaki | Gunma | Japan |
| Kitahiroshima | Hokkaido | Japan |
| Sapporo | Hokkaido | Japan |
| Himeji | Hyōgo | Japan |
| Takamatsu | Kagawa-ken | Japan |
| Yokohama | Kanagawa | Japan |
| Yokosuka | Kanagawa | Japan |
| Nagaoka | Niigata | Japan |
| Ōita | Oita Prefecture | Japan |
| Okayama | Okyama | Japan |
| Osaka | Osaka | Japan |
| Suita | Osaka | Japan |
| Chuo-ku | Tokyo | Japan |
| Edogawa-ku | Tokyo | Japan |
| Higashikurume | Tokyo | Japan |
| Koto-ku | Tokyo | Japan |
| Setagaya-ku | Tokyo | Japan |
| Yamagata | Yamagata | Japan |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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