An Efficacy Study of BCS Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD

NCT ID: NCT02269800

Last Updated: 2014-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Benzalkonium chloride solution

Tid, for 7 days.

Group Type EXPERIMENTAL

Benzalkonium chloride solution

Intervention Type DRUG

Tid, 7 days

Normal saline

Tid, for 7 days.

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type DRUG

Tid, 7 days

Interventions

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Benzalkonium chloride solution

Tid, 7 days

Intervention Type DRUG

Normal saline

Tid, 7 days

Intervention Type DRUG

Other Intervention Names

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You Ke Shi NS

Eligibility Criteria

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Inclusion Criteria

1. COPD patients in hospitalized.
2. Aged from18 to 70 years (including 18 and 70).
3. Patients participating in this trial should sign ICFs.
4. Patients with good understanding, could conduct this study with investigators.

Exclusion Criteria

1. History of mouthwash allergies, allergic rhinitis or dermatitis.
2. Patients with oral ulcers, severe periodontal disease, oral mucosal lesions or oral cancer, patients received special oral clean.
3. Patients with removable denture.
4. Patients with malignant blood diseases.
5. History of using cytotoxic drugs or biological immunosuppressants ( such as TNF-α inhibitors ).
6. Had used clinical study drugs before 28 days enrollment.
7. Had used clinical study drugs before 28 days enrollment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lustre Pharmaceutical Lab Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shiyue Li, Professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Guangzhou Medical University

Central Contacts

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Shiyue Li, Professor

Role: CONTACT

86 20 83062885

Other Identifiers

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LST-001

Identifier Type: -

Identifier Source: org_study_id

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