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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01715493
First received: September 10, 2012
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Asthma
Drug: lysozyme 90 mg
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom: a Randomised Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Change of several inflammatory or biochemical marker concentration in inducted sputum [ Time Frame: 8 weeks (2 periods each lasting 4 weeks) ] [ Designated as safety issue: No ]
  • Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration. [ Time Frame: 8 weeks (2 periods each lasting 4 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Monthly reduction in forced expiratory volume in 1 Second (FEV1) [ Time Frame: 8 weeks (2 periods each lasting 4 weeks) ] [ Designated as safety issue: No ]
  • Quality of life assessed by CAT (COPD Assessment Test) and ACT (Asthma Control Test) [ Time Frame: 8 weeks (2 periods each lasting 4 weeks) ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: October 2012
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lysozyme 90 mg Drug: lysozyme 90 mg
Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication)
Other Name: PRT10T
Placebo Comparator: Placebo Drug: Placebo
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 Name: PRT10T

  Eligibility

Ages Eligible for Study:   20 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715493

Locations
Japan
Mizunami, Gifu, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Kai Shibata Drug Fostering and Evoluation Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquaters
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01715493     History of Changes
Other Study ID Numbers: LYS-0003
Study First Received: September 10, 2012
Last Updated: July 17, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
COPD
Asthma
Lysozyme Hydrochloride

Additional relevant MeSH terms:
Asthma
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Muramidase
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014