Chronic Obstructive Pulmonary DiseasePhase 4NCT01715493
Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom
A Phase 4 study testing lysozyme 90 mg in people with Chronic Obstructive Pulmonary Disease and Asthma, run by Eisai Co., Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 84 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma
- What is being tested?
- lysozyme 90 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2012to Jan 2014
- 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
- 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
Show all 13Show fewer
- 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
Who cannot join
- Egg allergy
- Domiciliary oxygen therapy
- Pneumonia or pulmonary tuberculosis
- Patients with severe cardiovascular disorder, severe kidney disorder, severe hepatic disorder, severe hematological disorder
- Cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom: a Randomised Placebo-controlled Study
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
- Being tested
- lysozyme 90 mg, Placebo
- Keywords
- COPD, Asthma, Lysozyme Hydrochloride
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lysozyme 90 mgDrug
Also called PRT10T
Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication)
PlaceboDrug
Also called PRT10T
Lysozyme Matching Placebo three times daily for 4 weeks followed by Lysozyme 90 mg three times daily for 4 weeks (plus usual COPD medication)
| Study group | Role | What they receive |
|---|---|---|
| Lysozyme 90 mg | Experimental | Not described Receives: Drug: lysozyme 90 mg |
| 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.
Change of several inflammatory or biochemical marker concentration in inducted sputum
Measured: 8 weeks (2 periods each lasting 4 weeks)
Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration.
Measured: 8 weeks (2 periods each lasting 4 weeks)
Secondary outcomes (2)
Monthly reduction in forced expiratory volume in 1 Second (FEV1)
Measured: 8 weeks (2 periods each lasting 4 weeks)
Quality of life assessed by CAT (COPD Assessment Test) and ACT (Asthma Control Test)
Measured: 8 weeks (2 periods each lasting 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kai Shibata, Study director, Drug Fostering and Evoluation Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquaters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715493
- Sponsor's protocol ID
- LYS-0003
- Status last verified
- Jul 2014
- First submitted
- 10 Sep 2012
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom: a Randomised Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01715493
- Acronym / sponsor ID
- LYS-0003
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma
- Keywords
- COPD, Asthma, Lysozyme Hydrochloride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 29 Oct 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 was to assess the effectiveness for small airway inflammation of 4 weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lysozyme 90 mg | Experimental | Drug: lysozyme 90 mg |
| 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 (13 listed)
- 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
Key exclusion criteria (5 listed)
- Egg allergy
- Domiciliary oxygen therapy
- Pneumonia or pulmonary tuberculosis
- Patients with severe cardiovascular disorder, severe kidney disorder, severe hepatic disorder, severe hematological disorder
- 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 90 mgAlso: PRT10TLysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication) | Drug | Lysozyme 90 mg |
| PlaceboAlso: PRT10TLysozyme Matching Placebo three times daily for 4 weeks followed by Lysozyme 90 mg three times daily for 4 weeks (plus usual COPD medication) | Drug | Placebo |
Primary outcome
Change of several inflammatory or biochemical marker concentration in inducted sputum
Time frame: 8 weeks (2 periods each lasting 4 weeks)
Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration.
Time frame: 8 weeks (2 periods each lasting 4 weeks)
2 secondary outcomes
Monthly reduction in forced expiratory volume in 1 Second (FEV1)
Time frame: 8 weeks (2 periods each lasting 4 weeks)
Quality of life assessed by CAT (COPD Assessment Test) and ACT (Asthma Control Test)
Time frame: 8 weeks (2 periods each lasting 4 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 18 Jul 2014.
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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.
Kai Shibata study director
Drug Fostering and Evoluation Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquaters
1 site 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 90 mg in people with Chronic Obstructive Pulmonary Disease and Asthma, run by Eisai Co., Ltd. at 1 site 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 13 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 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change of several inflammatory or biochemical marker concentration in inducted sputum (time frame: 8 weeks (2 periods each lasting 4 weeks)). The study lists 2 primary outcomes in all. 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 18 Jul 2014.