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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Benzalkonium chloride solution; Drug: Normal saline

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shiyue Li, Professor; Phone Number: 86 20 83062885; Email: lishiyue@188.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Benzalkonium chloride solution; Tid, for 7 days.	Drug: Benzalkonium chloride solution; Tid, 7 days; Other Names: You Ke Shi
Active Comparator: Normal saline; Tid, for 7 days.	Drug: Normal saline; Tid, 7 days; Other Names: NS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Aerobic pathogenic bacterial colonization rate in oral airway	Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
The improvement of oral status	Day 7
The subjective feeling	Day 7
The incidence of hospital acquired respiratory infections	Day 7

Collaborators and Investigators

• Sponsor: Lustre Pharmaceutical Lab Co., Ltd
• Investigators: Principal Investigator: Shiyue Li, Professor, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: October 17, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Estimate): October 21, 2014
• Last Update Submitted That Met QC Criteria: October 17, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anti-Infective Agents, Local; Anti-Infective Agents; Benzalkonium Compounds
• Other Study ID Numbers: LST-001