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

NCT01715493 | Completed Phase 4

• 1 other identifier: LYS-0003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease; Asthma

Keywords

COPD; Asthma; Lysozyme Hydrochloride

Outcome Measures

Primary Outcomes (2)

• Change of several inflammatory or biochemical marker concentration in inducted sputum

  8 weeks (2 periods each lasting 4 weeks)

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

  8 weeks (2 periods each lasting 4 weeks)

Secondary Outcomes (2)

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

  8 weeks (2 periods each lasting 4 weeks)

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

  8 weeks (2 periods each lasting 4 weeks)

Study Arms (2)

Lysozyme 90 mg

EXPERIMENTAL

Drug: lysozyme 90 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

lysozyme 90 mg DRUG

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

Also known as: PRT10T

Lysozyme 90 mg

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)

Also known as: PRT10T

Placebo

Eligibility Criteria

• Age: 20 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Mizunami, Gifu, Japan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Interventions

Muramidase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Kai Shibata

  Drug Fostering and Evoluation Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquaters

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: October 29, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: July 18, 2014

Record last verified: 2014-07

Locations

JP (1)