Status:
COMPLETED
The Effect of Chlorhexidine on the Oral and Lung Microbiota in Chronic Obstructive Pulmonary Disease
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Veterans Medical Research Foundation
Flight Attendant Medical Research Institute
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief Summary
Determine the effect of twice-daily chlorhexidine oral rinse on oral and lung microbiota biomass in subjects with chronic obstructive pulmonary disease (COPD) with chronic bronchitis. Our primary outc...
Detailed Description
Our hypothesis is that 8 weeks of chlorhexidine oral rinse will decrease microbiota biomass compared to baseline and those on placebo. Furthermore, we hypothesize that chlorhexidine treatment will: i)...
Eligibility Criteria
Inclusion
- Willingness to undergo sputum induction
- Capability to provide written informed consent
- Age ≥ 40 years and ≤ 85 years
- FEV1/FVC ratio (post bronchodilator) ≤70%
- FEV1 (post bronchodilator) ≤ 65%
- Presence or high likelihood of chronic cough and sputum production defined as one of the following:
- Presence of chronic cough and sputum will be defined by responses to the first two questions on the SGRQ. Subjects who respond positively to both question 1 (cough) and question 2 (sputum) on the SGRQ as either "several days per week" or "almost every day" will be eligible.
- COPD exacerbation within the previous 12 months defined as taking antibiotics and/or prednisone for respiratory symptoms, hospitalization or emergency department visit for respiratory illness.
- Current or former smoker with lifetime cigarette consumption of \> 10 pack-years
- Negative serum pregnancy test at the baseline visit if patient is a pre-menopausal female (menopause defined as absence of a menstrual cycle in the last 12 months)
- Must be fluent in speaking the English language
- Have a minimum of four teeth
Exclusion
- Not fully recovered for at least 30 days from a COPD exacerbation.
- Treated with antibiotics in the last 2 months.
- The presence of dentures (full plate).
- Active oral infection being treated by health care professional.
- Current use of chlorhexidine or over-the-counter mouth washes in the last 2 months.
- Known allergy or sensitivity to chlorhexidine
- Unstable cardiac disease
- Clinical diagnosis of asthma, bronchiectasis, cystic fibrosis, or severe alpha-1 antitrypsin deficiency
- Active lung cancer or history of lung cancer if it has been less than 2 years since lung resection or other treatment. If history of lung cancer, must have no evidence of recurrence in the 2 years preceding the baseline visit.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT02252588
Start Date
September 1 2014
End Date
January 1 2020
Last Update
December 29 2020
Active Locations (1)
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1
VA Medical Center
Minneapolis, Minnesota, United States, 55417