NCT01645800 is a Phase 4 clinical trial of Lysozyme hydrochloride in COPD, sponsored by Eisai Co., Ltd..

Who is sponsoring NCT01645800?

NCT01645800 is sponsored by Eisai Co., Ltd..

What drugs are being tested in NCT01645800?

Interventions in NCT01645800: Lysozyme hydrochloride, Placebo.

Is NCT01645800 still recruiting?

NCT01645800 is currently completed. Last updated 20 October 2015.

Last reviewed 2015-10-20 · How we verify

NCT01645800

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effects of Lysozyme On Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study

Completed Phase 4 Last updated 20 October 2015

What this trial tests

Phase 4 trial testing Lysozyme hydrochloride in COPD in 408 participants. Completed in 1 March 2015.

Timeline

1 August 2012

Primary endpoint
1 January 2015

1 March 2015

Quick facts

Lead sponsor	Eisai Co., Ltd.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	408
Start date	1 August 2012
Primary completion	1 January 2015
Estimated completion	1 March 2015
Sites	25 locations across Japan

Drugs / interventions tested

Lysozyme hydrochloride — full drug profile →
Placebo

Conditions studied

COPD — all drugs for COPD →

Sponsor

Eisai Co., Ltd. — full company profile →

Who can join

Adults 20 to 84, any sex, with COPD. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Acute exacerbation of COPD
Time frame: 52 weeks

Sponsor's own description

The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Prevention of COPD exacerbation by lysozyme: a double-blind, randomized, placebo-controlled study.
Fukuchi Y, Tatsumi K, Inoue H, Sakata Y, et al · · 2016 · cited 10× · PMID 27143873 · DOI 10.2147/copd.s103105
Correlates between models of virulence for Mycobacterium tuberculosis among isolates of the Central Asian lineage: a case for lysozyme resistance testing?
Pardieu C, Casali N, Clark SO, Hooper R, et al · · 2015 · cited 1× · PMID 25776753 · DOI 10.1128/iai.03080-14

Verify or expand the search:

Other recruiting trials for COPD

Currently open trials in the same condition.

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NCT07462221 — Effect of Telenursing on Oral Health · NA · recruiting
NCT07051707 — Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD · NA · recruiting

Other Eisai Co., Ltd. trials

Trials by the same sponsor.

NCT07515014 — A Study of E6742 in Participants With Systemic Lupus Erythematosus · Phase 2 · not yet recruiting
NCT06793709 — A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast G · recruiting
NCT06657378 — A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized T · recruiting
NCT06322667 — A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab · recruiting
NCT05633108 — A Study Based on the French National Health Insurance Database in Participants With Psychotic Disorders · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01645800 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Co., Ltd.
Last refreshed: 20 October 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01645800.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing