The Effect of Chlorhexidine on the Oral and Lung Microbiota in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Chlorhexidine; Placebo
Intervention description: Oral Rinse; Oral Rinse
Intervention MeSH terms: Chlorhexidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: COPD; Bacteria

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 outcome will be to compare the microbiota biomass (number of bacteria
      as measured by 16S rRNA copy number) of induced sputum and the oral cavity before and after 8
      weeks of twice-daily chlorhexidine oral rinse (n=25) compared to controls (n=25) using qPCR
      and next-generation sequencing of the bacterial 16S rRNA gene comparing total bacterial
      biomass
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.