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
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 chronic-obstructive-pulmonary-disease
Started Oct 2014
Shorter than P25 for phase_4 chronic-obstructive-pulmonary-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 17, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedOctober 21, 2014
October 1, 2014
9 months
October 17, 2014
October 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Aerobic pathogenic bacterial colonization rate in oral airway
Day 7
Secondary Outcomes (3)
The improvement of oral status
Day 7
The subjective feeling
Day 7
The incidence of hospital acquired respiratory infections
Day 7
Study Arms (2)
Benzalkonium chloride solution
EXPERIMENTALTid, for 7 days.
Normal saline
ACTIVE COMPARATORTid, for 7 days.
Interventions
Tid, 7 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shiyue Li, Professor
The First Affiliated Hospital of Guangzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2014
First Posted
October 21, 2014
Study Start
October 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
October 21, 2014
Record last verified: 2014-10