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

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ClinicalTrials.gov Identifier: NCT02269800
Recruitment Status : Unknown
Verified October 2014 by Lustre Pharmaceutical Lab Co., Ltd.
Recruitment status was:  Not yet recruiting
First Posted : October 21, 2014
Last Update Posted : October 21, 2014
Sponsor:
Information provided by (Responsible Party):
Lustre Pharmaceutical Lab Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Benzalkonium chloride solution Drug: Normal saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Efficacy Study of Benzalkonium Chloride Solution Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD
Study Start Date : October 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Benzalkonium chloride solution
Tid, for 7 days.
Drug: Benzalkonium chloride solution
Tid, 7 days
Other Name: You Ke Shi

Active Comparator: Normal saline
Tid, for 7 days.
Drug: Normal saline
Tid, 7 days
Other Name: NS




Primary Outcome Measures :
  1. Aerobic pathogenic bacterial colonization rate in oral airway [ Time Frame: Day 7 ]

Secondary Outcome Measures :
  1. The improvement of oral status [ Time Frame: Day 7 ]
  2. The subjective feeling [ Time Frame: Day 7 ]
  3. The incidence of hospital acquired respiratory infections [ Time Frame: Day 7 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269800


Contacts
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Contact: Shiyue Li, Professor 86 20 83062885 lishiyue@188.com

Sponsors and Collaborators
Lustre Pharmaceutical Lab Co., Ltd
Investigators
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Principal Investigator: Shiyue Li, Professor The First Affiliated Hospital of Guangzhou Medical University

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Responsible Party: Lustre Pharmaceutical Lab Co., Ltd
ClinicalTrials.gov Identifier: NCT02269800     History of Changes
Other Study ID Numbers: LST-001
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: October 21, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Benzalkonium Compounds
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents