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Completed

NCT Number: NCT01645800

Effects of Lysozyme on Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study

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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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

20 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nishio, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lysozyme hydrochloride

Drug

LYL 90mg capsule: Three times daily for 52 weeks.

Placebo

Drug

Matching Placebo capsule: Three times daily for 52 weeks.

Primary outcomes

  1. Acute exacerbation of COPD

    Time frame: 52 weeks

Secondary outcomes

  1. Yearly reduction in FEV1 and QOL assessed by CAT

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 20, 2012
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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