Chronic Obstructive Pulmonary DiseasePhase 4NCT02269800
An Efficacy Study of BCS Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD
A Phase 4 study testing Benzalkonium chloride solution and Normal saline in people with Chronic Obstructive Pulmonary Disease, run by Lustre Pharmaceutical Lab Co., Ltd.
Trial summary
The purpose of study is to evaluate the efficacy and safety of Benzalkonium Chloride Solution clearing the oral colonized bacterium in hospitalized patients with COPD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Benzalkonium chloride solution and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Jul 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients in hospitalized.
- Aged from18 to 70 years (including 18 and 70).
- Patients participating in this trial should sign ICFs.
- Patients with good understanding, could conduct this study with investigators.
Who cannot join
- History of mouthwash allergies, allergic rhinitis or dermatitis.
- Patients with oral ulcers, severe periodontal disease, oral mucosal lesions or oral cancer, patients received special oral clean.
- Patients with removable denture.
- Patients with malignant blood diseases.
- History of using cytotoxic drugs or biological immunosuppressants ( such as TNF-α inhibitors ).
- Had used clinical study drugs before 28 days enrollment.
- Had used clinical study drugs before 28 days enrollment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Efficacy Study of Benzalkonium Chloride Solution Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD
The purpose of study is to evaluate the efficacy and safety of Benzalkonium Chloride Solution clearing the oral colonized bacterium in hospitalized patients with COPD.
Read the detailed description
This a randomized, double-blind, parallel, single-center, exploratory trial. 60 patients will be randomized to two treatments: benzalkonium chloride solution treatment or normal saline treatment.The purpose of study is to evaluate the efficacy and safety of benzalkonium chloride solution clearing the oral colonized bacterium in hospitalized patients with COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Benzalkonium chloride solution, Normal saline
- 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.
Benzalkonium chloride solutionDrug
Also called You Ke Shi
Tid, 7 days
Normal salineDrug
Also called NS
Tid, 7 days
| Study group | Role | What they receive |
|---|---|---|
| Benzalkonium chloride solution | Experimental | Tid, for 7 days. Receives: Drug: Benzalkonium chloride solution |
| Normal saline | Active comparator | Tid, for 7 days. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic pathogenic bacterial colonization rate in oral airway
Measured: Day 7
Secondary outcomes (3)
The improvement of oral status
Measured: Day 7
The subjective feeling
Measured: Day 7
The incidence of hospital acquired respiratory infections
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lustre Pharmaceutical Lab Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shiyue Li, Professor, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269800
- Sponsor's protocol ID
- LST-001
- Status last verified
- Oct 2014
- First submitted
- 17 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy Study of Benzalkonium Chloride Solution Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD
- ClinicalTrials.gov ID
- NCT02269800
- Acronym / sponsor ID
- LST-001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lustre Pharmaceutical Lab Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 21 Oct 2014 (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 purpose of study is to evaluate the efficacy and safety of Benzalkonium Chloride Solution clearing the oral colonized bacterium in hospitalized patients with COPD.
Detailed description
This a randomized, double-blind, parallel, single-center, exploratory trial. 60 patients will be randomized to two treatments: benzalkonium chloride solution treatment or normal saline treatment.The purpose of study is to evaluate the efficacy and safety of benzalkonium chloride solution clearing the oral colonized bacterium in hospitalized patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benzalkonium chloride solution | Experimental | Drug: Benzalkonium chloride solutionTid, for 7 days. |
| Normal saline | Active comparator | Drug: Normal salineTid, for 7 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD patients in hospitalized.
- Aged from18 to 70 years (including 18 and 70).
- Patients participating in this trial should sign ICFs.
- Patients with good understanding, could conduct this study with investigators.
Key exclusion criteria (7 listed)
- History of mouthwash allergies, allergic rhinitis or dermatitis.
- Patients with oral ulcers, severe periodontal disease, oral mucosal lesions or oral cancer, patients received special oral clean.
- Patients with removable denture.
- Patients with malignant blood diseases.
- History of using cytotoxic drugs or biological immunosuppressants ( such as TNF-α inhibitors ).
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 |
|---|---|---|
| Benzalkonium chloride solutionAlso: You Ke ShiTid, 7 days | Drug | Benzalkonium chloride solution |
| Normal salineAlso: NSTid, 7 days | Drug | Normal saline |
Primary outcome
Aerobic pathogenic bacterial colonization rate in oral airway
Time frame: Day 7
3 secondary outcomes
The improvement of oral status
Time frame: Day 7
The subjective feeling
Time frame: Day 7
The incidence of hospital acquired respiratory infections
Time frame: Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 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.
Shiyue Li, Professor principal investigator
The First Affiliated Hospital of Guangzhou Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Benzalkonium chloride solution and Normal saline in people with Chronic Obstructive Pulmonary Disease, run by Lustre Pharmaceutical Lab Co., Ltd.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiyue Li, Professor (86 20 83062885, lishiyue@188.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic pathogenic bacterial colonization rate in oral airway (time frame: Day 7). 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 2014.