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

Phase 4

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Normal saline; Drug: Benzalkonium chloride solution

• Registration Number: NCT02269800
• Lead Sponsor: Lustre Pharmaceutical Lab Co., Ltd

Brief 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.

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 Timeline

• Status Verified: 2014-10
• Study Start: 2014-10
• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-17
• Last Update Submitted: 2014-10-17
• Study First Posted: 2014-10-21
• Last Update Posted: 2014-10-21
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	Tid, for 7 days.
Benzalkonium chloride solution	Benzalkonium chloride solution	Tid, for 7 days.

Primary Outcome Measures

Name	Time	Method
Aerobic pathogenic bacterial colonization rate in oral airway	Day 7

Secondary Outcome Measures

Name	Time	Method
The improvement of oral status	Day 7
The subjective feeling	Day 7
The incidence of hospital acquired respiratory infections	Day 7