Status:
UNKNOWN
An Efficacy Study of BCS Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD
Lead Sponsor:
Lustre Pharmaceutical Lab Co., Ltd
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02269800
Start Date
October 1 2014
End Date
July 1 2015
Last Update
October 21 2014
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