The Effect of Chlorhexidine on the Oral and Lung Microbiota in Chronic Obstructive Pulmonary Disease

NCT02252588 | Completed Phase 2 Results

• 1 other identifier: 4526
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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 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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Bacteria

Outcome Measures

Primary Outcomes (1)

• Change in Sputum Bacteria Biomass

  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 Outcomes (2)

• Breathlessness, Cough, and Sputum Scale (BCSS)

  Baseline, 8 weeks

• Change in St George Respiratory Quotient (SGRQ)

  baseline, 8 weeks

Study Arms (2)

Chlorhexidine

EXPERIMENTAL

Oral Rinse

Drug: Chlorhexidine; Other: Placebo

Placebo

PLACEBO COMPARATOR

Oral Rinse

Drug: Chlorhexidine; Other: Placebo

Interventions

Chlorhexidine DRUG

Oral Rinse

Chlorhexidine; Placebo

Placebo OTHER

Oral Rinse

Chlorhexidine; Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• Veterans Medical Research Foundation: collaborator
• Flight Attendant Medical Research Institute: collaborator

Study Sites (1)

VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (1)

• Pragman AA, Fieberg AM, Reilly CS, Wendt C. Chlorhexidine oral rinses for symptomatic COPD: a randomised, blind, placebo-controlled preliminary study. BMJ Open. 2021 Dec 13;11(12):e050271. doi: 10.1136/bmjopen-2021-050271.

  PMID: 34903538 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Christine Wendt, MD
• Organization: University of Minnesota

wendt005@umn.edu

612-624-0999

Study Officials

• Chris Wendt, MD

  VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 30, 2014
• Study Start: September 1, 2014
• Primary Completion: December 15, 2019
• Study Completion: January 1, 2020
• Last Updated: December 29, 2020
• Results First Posted: December 29, 2020

Record last verified: 2020-12

Locations

US (1)