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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02269800

Enrollment

Registered

2014-10-21

Start date

2014-10-31

Completion date

2015-07-31

Last updated

2014-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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.

Interventions

DRUGBenzalkonium chloride solution

Tid, 7 days

DRUGNormal saline

Tid, 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactShiyue Li, Professor

lishiyue@188.com86 20 83062885

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026