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

Phase 4

Completed

• Conditions: Asthma; Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Placebo; Drug: lysozyme 90 mg

• Registration Number: NCT01715493
• Lead Sponsor: Eisai Co., Ltd.

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 available

Study Timeline

• Study First Submitted: 2012-09-10
• Study Start: 2012-10
• Study First Submitted QC: 2012-10-24
• Study First Posted: 2012-10-29
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-17
• Last Update Posted: 2014-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Lysozyme 90 mg	lysozyme 90 mg	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)