- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02252588
The Effect of Chlorhexidine on the Oral and Lung Microbiota in Chronic Obstructive Pulmonary Disease (CLIMB)
The Effect of Chlorhexidine on the Oral and Lung Microbiota in Chronic Obstructive
Study Overview
Status
Conditions
Intervention / Treatment
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) decrease lung and oral microbiota diversity; ii) alter microbiota taxonomic composition in the lung and oral cavity; iii) decrease systemic inflammation as measured by blood high sensitivity C-reactive protein (hsCRP), fibrinogen and leukocyte count; and iv) demonstrate a trend towards improvement in respiratory health status as measured by the Breathlessness, Cough, and Sputum Scale (BCSS)[1, 2] and St. George's Respiratory Questionnaire (SGRQ).
Subaim 1: Determine if chlorhexidine alters the lung and oral rinse microbiota diversity and taxonomic composition. Our hypothesis is that chlorhexidine oral rinse will decrease the diversity (Shannon and inverse Simpson diversity indices) and taxonomic composition of both oral and lung microbiota compared to those on placebo as determined by next-generation sequencing of the bacterial 16S rRNA gene.
Subaim 2: Determine the impact of chlorhexidine on systemic inflammation. Our hypothesis is that the decrease in lung microbiota biomass is associated with a decrease in systemic inflammation as measured by blood hsCRP, fibrinogen, and leukocyte count.
Subaim 3: Determine if respiratory symptoms associate with the lung microbiota biomass. Our hypothesis is that chlorhexidine will demonstrate improved respiratory health status as measured by the BCSS and SGRQ.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Minnesota
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Minneapolis, Minnesota, United States, 55417
- VA Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chlorhexidine
Oral Rinse
|
Oral Rinse
Oral Rinse
|
Placebo Comparator: Placebo
Oral Rinse
|
Oral Rinse
Oral Rinse
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Sputum Bacteria Biomass
Time Frame: Baseline, 8 weeks
|
Samples underwent DNA extraction and 16S rRNA quantification and 16S rRNA V4 MiSeq sequencing was performed at the University of Minnesota Genomics Center.
The biomass was the number of bacteria as measured by 16S rRNA copy number.
To adjust biomass for the size of the sputum sample, raw counts were normalized by dividing by the sample volume or mass.
|
Baseline, 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breathlessness, Cough, and Sputum Scale (BCSS)
Time Frame: Baseline, 8 weeks
|
The Breathlessness, Cough, and Sputum Scale (BCSS) is a brief, three-item, patient-reported outcome measure in which each of the three symptoms assessed by the measure is represented by a single item.
Patients are asked to evaluate each symptom/item on a 5-point Likert-type scale, ranging from 0 to 4. Total scores range from 0 to 12 with higher scores indicating a more severe manifestation of the symptom.
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Baseline, 8 weeks
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Change in St George Respiratory Quotient (SGRQ)
Time Frame: baseline, 8 weeks
|
The St George Respiratory Quotient (SGRQ) contains 50 items measuring symptoms of and activities affected by obstructive airway disease.
Total score is a sum of item scores and ranges from 0 to 100, with higher scores indicating more limitations.
The minimally significant difference is 4.
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baseline, 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chris Wendt, MD, VA Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4526
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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