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Completed

NCT Number: NCT01715493

Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom

The aim of this study was to assess the effectiveness for small airway inflammation of 4 weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Asthma Bronchial Diseases Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

20 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mizunami, Gifu, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

For COPD:

  • Over 20 years of age and below 85 years of age
  • Smoking history
  • Brinkman index 200 or more
  • Diagnosis of COPD
  • Forced expiratory volume in 1 second (FEV1) of <80% of the predicted value
  • Ratio of FEV1 to forced vital capacity (FVC) of <70%
  • symptom of expectorated sputum

For Asthma

  • Over 20 years of age and below 85 years of age
  • Scored between 20 to 24 by ACT (Asthma Control Test)
  • Symptom of expectorated sputum
  • Diagnosed partly controlled by global initiative for asthma

Exclusion criteria

  • Egg allergy
  • Domiciliary oxygen therapy
  • Pneumonia or pulmonary tuberculosis
  • Patients with severe cardiovascular disorder, severe kidney disorder, severe hepatic disorder, severe hematological disorder
  • Cancer

Treatment and study plan

lysozyme 90 mg

Drug

Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication)

Other names: PRT10T

Placebo

Drug

Lysozyme Matching Placebo three times daily for 4 weeks followed by Lysozyme 90 mg three times daily for 4 weeks (plus usual COPD medication)

Other names: PRT10T

Primary outcomes

  1. Change of several inflammatory or biochemical marker concentration in inducted sputum

    Time frame: 8 weeks (2 periods each lasting 4 weeks)

  2. Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration.

    Time frame: 8 weeks (2 periods each lasting 4 weeks)

Secondary outcomes

  1. Monthly reduction in forced expiratory volume in 1 Second (FEV1)

    Time frame: 8 weeks (2 periods each lasting 4 weeks)

  2. Quality of life assessed by CAT (COPD Assessment Test) and ACT (Asthma Control Test)

    Time frame: 8 weeks (2 periods each lasting 4 weeks)

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom: a Randomised Placebo-controlled Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 29, 2012
Registry last updated
Jul 18, 2014

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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