Trial Outcomes & Findings for The Effect of Chlorhexidine on the Oral and Lung Microbiota in Chronic Obstructive Pulmonary Disease (NCT NCT02252588)

Last Updated: 2020-12-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

Baseline, 8 weeks

Results posted on

2020-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	Chlorhexidine Oral Rinse Chlorhexidine: Oral Rinse Placebo: Oral Rinse	Placebo Oral Rinse Chlorhexidine: Oral Rinse Placebo: Oral Rinse
Overall Study STARTED	24	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Chlorhexidine Oral Rinse Chlorhexidine: Oral Rinse Placebo: Oral Rinse	Placebo Oral Rinse Chlorhexidine: Oral Rinse Placebo: Oral Rinse
Overall Study Withdrawal by Subject	4	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chlorhexidine n=24 Participants Oral Rinse Chlorhexidine: Oral Rinse Placebo: Oral Rinse	Placebo n=20 Participants Oral Rinse Chlorhexidine: Oral Rinse Placebo: Oral Rinse	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	1 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	19 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	19 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	20 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 8 weeks

Outcome measures

Outcome measures
Measure	Chlorhexidine n=20 Participants Oral Rinse Chlorhexidine: Oral Rinse Placebo: Oral Rinse	Placebo n=20 Participants Oral Rinse Chlorhexidine: Oral Rinse Placebo: Oral Rinse
Change in Sputum Bacteria Biomass	-0.24 log10 molecules/uL/mL Standard Deviation 11.7	-0.14 log10 molecules/uL/mL Standard Deviation 0.32

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Chlorhexidine n=20 Participants Oral Rinse Chlorhexidine: Oral Rinse Placebo: Oral Rinse	Placebo n=20 Participants Oral Rinse Chlorhexidine: Oral Rinse Placebo: Oral Rinse
Breathlessness, Cough, and Sputum Scale (BCSS)	0.42 units on a scale Standard Deviation 1.24	-0.38 units on a scale Standard Deviation 1.13

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Chlorhexidine n=20 Participants Oral Rinse Chlorhexidine: Oral Rinse Placebo: Oral Rinse	Placebo n=20 Participants Oral Rinse Chlorhexidine: Oral Rinse Placebo: Oral Rinse
Change in St George Respiratory Quotient (SGRQ)	-4.7 score on a scale Standard Deviation 8	1.7 score on a scale Standard Deviation 8.9

Adverse Events

Chlorhexidine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Chlorhexidine n=24 participants at risk Oral Rinse Chlorhexidine: Oral Rinse Placebo: Oral Rinse	Placebo n=20 participants at risk Oral Rinse Chlorhexidine: Oral Rinse Placebo: Oral Rinse
Skin and subcutaneous tissue disorders Irritation and/or sores of the lining of the mouth	0.00% 0/24 • 8 weeks	5.0% 1/20 • Number of events 1 • 8 weeks
General disorders Other oral side effects	8.3% 2/24 • Number of events 2 • 8 weeks	0.00% 0/20 • 8 weeks
Respiratory, thoracic and mediastinal disorders Congestion, Sinus Infection, and Cough	0.00% 0/24 • 8 weeks	15.0% 3/20 • Number of events 3 • 8 weeks

Additional Information

Christine Wendt, MD

University of Minnesota

Phone: 612-624-0999

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place