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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

An Efficacy Study of Benzalkonium Chloride Solution Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02269800
• Other study ID #: LST-001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 17, 2014
• Last updated: October 17, 2014
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: October 2014
• Source: Lustre Pharmaceutical Lab Co., Ltd
• Contact: Shiyue Li, Professor
• Phone: 86 20 83062885
• Email: lishiyue[@]188.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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-a inhibitors ).

6. Had used clinical study drugs before 28 days enrollment.

7. Had used clinical study drugs before 28 days enrollment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Benzalkonium chloride solution
Tid, 7 days
• Normal saline
Tid, 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lustre Pharmaceutical Lab Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aerobic pathogenic bacterial colonization rate in oral airway		Day 7	No
Secondary	The improvement of oral status		Day 7	No
Secondary	The subjective feeling		Day 7	No
Secondary	The incidence of hospital acquired respiratory infections		Day 7	Yes