Pharmacological Effect of Lysozyme for Chronic Obstructiv... | NCT01715493

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

NCT01715493

Sponsor

Eisai Co., Ltd.

Status

Completed

Last Update Posted

Jul 18, 2014Estimated

Enrollment

48Actual

Phase

Phase 4

Conditions

Chronic Obstructive Pulmonary Disease
Asthma

Interventions

lysozyme 90 mg
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

Sep 10, 2012

First Submission Date that Met QC Criteria

Oct 24, 2012

First Posted Date

Oct 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2014

Last Update Posted Date

Jul 18, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lysozyme 90 mg	Experimental		Drug: lysozyme 90 mg
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lysozyme 90 mg	Drug	Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication)	Lysozyme 90 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kai Shibata	Drug Fostering and Evoluation Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquaters	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Mizunami	Gifu		Japan

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D001249	Asthma

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009113	Muramidase

Ancestor Terms

ID	Term
D006026	Glycoside Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes

Browse Leaves

Not provided

Browse Branches

Not provided