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

This study is currently recruiting participants.
Verified October 2012 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01715493
First received: September 10, 2012
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 48
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715493

Contacts
Contact: Customer Information Services Department. CRC and QA _ML_CLNCL@hhc.eisai.co.jp

Locations
Japan
Recruiting
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: October 24, 2012
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
Respiration Disorders
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 May 22, 2013