The Effect of Chlorhexidine on the Oral and Lung Microbiota in Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT02252588 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Sputum Bacteria Biomass |
-0.24; -0.14 | — |
| SECONDARY Breathlessness, Cough, and Sputum Scale (BCSS) |
0.42; -0.38 | — |
| SECONDARY Change in St George Respiratory Quotient (SGRQ) |
-4.7; 1.7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02252588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.