COPDPhase 4NCT01645800
Effects of Lysozyme on Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study
A Phase 4 study testing Lysozyme hydrochloride in people with COPD, run by Eisai Co., Ltd. at 25 sites in Japan.
Trial summary
The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD. Read more about this study
- Who is it for?
- Ages 20 to 84 years
- Conditions the study is for
- COPD
- What is being tested?
- Lysozyme hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 408 participants
- Where
- 25 sitesJapan
- Study dates
- Aug 2012to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were eligible for inclusion in the study if they were over 20 years of age and below 85 years of age, and had a smoking history, a diagnosis of COPD, a ratio of FEV1 to forced vital capacity(FVC) of less than 70%, and a documented history of at least one exacerbation leading to any treatment within the previous year.
Who cannot join
- Patients with egg allergy
- Patients with domiciliary oxygen therapy
- Patients with pneumonia or pulmonary tuberculosis
- Patients with severe cardiovascular disorder,severe kidney disorder, severe hepatic disorder, severe hematological disorder.
- Patients with cancer.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Study site
Chuo-ku, Tokyo
Study site
Edogawa-ku, Tokyo
Study site
Fukuoka, Fukuoka
Study site
Higashikurume, Tokyo
Study site
Himeji, Hyōgo
Study site
Kasuga, Fukuoka
Study site
Kitahiroshima, Hokkaido
Study site
Koto-ku, Tokyo
Study site
Kyoto-gun, Fukuoka
Study site
Mabashi, Gunma
Study site
Nagaoka, Niigata
Study site
Nishio, Aichi-ken
Study site
Noda, Chiba
Study site
Ōita, Oita Prefecture
Study site
Okayama, Okyama
Study site
Osaka, Osaka
Study site
Sapporo, Hokkaido
Study site
Setagaya-ku, Tokyo
Study site
Suita, Osaka
Study site
Takamatsu, Kagawa-ken
Study site
Takasaki, Gunma
Study site
Yamagata, Yamagata
Study site
Yanagawa, Fukuoka
Study site
Yokohama, Kanagawa
Study site
Yokosuka, Kanagawa
About this study
Official title: Effects of Lysozyme On Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study
The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.
- Conditions
- COPD
- Being tested
- Lysozyme hydrochloride, Placebo
- Keywords
- Lysozyme hydrochloride, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lysozyme hydrochlorideDrug
LYL 90mg capsule: Three times daily for 52 weeks.
PlaceboDrug
Matching Placebo capsule: Three times daily for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lysozyme hydrochloride | Experimental | Not described Receives: Drug: Lysozyme hydrochloride |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute exacerbation of COPD
Measured: 52 weeks
Secondary outcomes (1)
Yearly reduction in FEV1 and QOL assessed by CAT
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yukinori Sakata, Study director, Drug Fostering and evolution Coodination Department, Corporate Regulattory Compliance, Safety and Quality Assurance Headquaters, Eisai Co., Ltd., Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645800
- Sponsor's protocol ID
- LYS-002
- Status last verified
- Oct 2015
- First submitted
- 18 Jul 2012
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lysozyme On Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT01645800
- Acronym / sponsor ID
- LYS-002
- Conditions
- COPD
- Keywords
- Lysozyme hydrochloride, COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lysozyme hydrochloride | Experimental | Drug: Lysozyme hydrochloride |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients were eligible for inclusion in the study if they were over 20 years of age and below 85 years of age, and had a smoking history, a diagnosis of COPD, a ratio of FEV1 to forced vital capacity(FVC) of less than 70%, and a documented history of at least one exacerbation leading to any treatment within the previous year.
Key exclusion criteria (5 listed)
- Patients with egg allergy
- Patients with domiciliary oxygen therapy
- Patients with pneumonia or pulmonary tuberculosis
- Patients with severe cardiovascular disorder,severe kidney disorder, severe hepatic disorder, severe hematological disorder.
- Patients with cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lysozyme hydrochlorideLYL 90mg capsule: Three times daily for 52 weeks. | Drug | Lysozyme hydrochloride |
| PlaceboMatching Placebo capsule: Three times daily for 52 weeks. | Drug | Placebo |
Primary outcome
Acute exacerbation of COPD
Time frame: 52 weeks
1 secondary outcome
Yearly reduction in FEV1 and QOL assessed by CAT
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yukinori Sakata study director
Drug Fostering and evolution Coodination Department, Corporate Regulattory Compliance, Safety and Quality Assurance Headquaters, Eisai Co., Ltd., Japan
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lysozyme hydrochloride in people with COPD, run by Eisai Co., Ltd. at 25 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute exacerbation of COPD (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015; AzTrials last refreshed its copy on 7 Nov 2026.