Back to resultsAn Efficacy Study of BCS Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Benzalkonium chloride solution
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- COPD patients in hospitalized.
- Aged from18 to 70 years (including 18 and 70).
- Patients participating in this trial should sign ICFs.
- Patients with good understanding, could conduct this study with investigators.
Exclusion Criteria:
- History of mouthwash allergies, allergic rhinitis or dermatitis.
- Patients with oral ulcers, severe periodontal disease, oral mucosal lesions or oral cancer, patients received special oral clean.
- Patients with removable denture.
- Patients with malignant blood diseases.
- History of using cytotoxic drugs or biological immunosuppressants ( such as TNF-α inhibitors ).
- Had used clinical study drugs before 28 days enrollment.
- Had used clinical study drugs before 28 days enrollment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Benzalkonium chloride solution
Normal saline
Arm Description
Tid, for 7 days.
Tid, for 7 days.
Outcomes
Primary Outcome Measures
Aerobic pathogenic bacterial colonization rate in oral airway
Secondary Outcome Measures
The improvement of oral status
The subjective feeling
The incidence of hospital acquired respiratory infections
Full Information
NCT ID
NCT02269800
First Posted
October 17, 2014
Last Updated
October 17, 2014
Sponsor
Lustre Pharmaceutical Lab Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02269800
Brief Title
An Efficacy Study of BCS Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD
Official Title
An Efficacy Study of Benzalkonium Chloride Solution Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lustre Pharmaceutical Lab Co., Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Benzalkonium chloride solution
Arm Type
Experimental
Arm Description
Tid, for 7 days.
Arm Title
Normal saline
Arm Type
Active Comparator
Arm Description
Tid, for 7 days.
Intervention Type
Drug
Intervention Name(s)
Benzalkonium chloride solution
Other Intervention Name(s)
You Ke Shi
Intervention Description
Tid, 7 days
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
NS
Intervention Description
Tid, 7 days
Primary Outcome Measure Information:
Title
Aerobic pathogenic bacterial colonization rate in oral airway
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
The improvement of oral status
Time Frame
Day 7
Title
The subjective feeling
Time Frame
Day 7
Title
The incidence of hospital acquired respiratory infections
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD patients in hospitalized.
Aged from18 to 70 years (including 18 and 70).
Patients participating in this trial should sign ICFs.
Patients with good understanding, could conduct this study with investigators.
Exclusion Criteria:
History of mouthwash allergies, allergic rhinitis or dermatitis.
Patients with oral ulcers, severe periodontal disease, oral mucosal lesions or oral cancer, patients received special oral clean.
Patients with removable denture.
Patients with malignant blood diseases.
History of using cytotoxic drugs or biological immunosuppressants ( such as TNF-α inhibitors ).
Had used clinical study drugs before 28 days enrollment.
Had used clinical study drugs before 28 days enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyue Li, Professor
Phone
86 20 83062885
Email
lishiyue@188.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyue Li, Professor
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
An Efficacy Study of BCS Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD
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