Trial Outcomes & Findings for Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations (NCT NCT01988779)

NCT ID: NCT01988779

Last Updated: 2021-03-24

Results Overview

The Rhinosinusitis Disability Index is a 30-item questionnaire completed by the patient or subject. Each item has a value of zero to four, a higher score indicates a self-perception of worse symptoms. The minimum score is zero and the maximum score is 120. The difference score here is the post-treatment score minus the pre-treatment score, with lower meaning more improvement

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

33 participants

Primary outcome timeframe

Baseline and 14 days after treatment

Results posted on

2021-03-24

Participant Flow

8 participants screen failed before randomization to the intervention.

Participant milestones

Participant milestones
Measure	Oral Placebo With Nebulized Intranasal Levofloxacin Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days oral levofloxacin nebulized levofloxacin	Oral Antibiotics With Nebulized Intranasal Placebo Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. oral levofloxacin nebulized levofloxacin
Overall Study STARTED	12	13
Overall Study COMPLETED	9	11
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Placebo With Nebulized Intranasal Levofloxacin Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days oral levofloxacin nebulized levofloxacin	Oral Antibiotics With Nebulized Intranasal Placebo Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. oral levofloxacin nebulized levofloxacin
Overall Study Withdrawal by Subject	2	2
Overall Study Protocol Violation	1	0

Baseline Characteristics

Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline and 14 days after treatment

Outcome measures

Outcome measures
Measure	Oral Placebo With Nebulized Intranasal Levofloxacin n=9 Participants Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days oral levofloxacin nebulized levofloxacin	Oral Antibiotics With Nebulized Intranasal Placebo n=11 Participants Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. oral levofloxacin nebulized levofloxacin
Change in Rhinosinusitis Disability Index (RSDI) Score	-8.000 units on a scale Standard Deviation 29.47	-14.82 units on a scale Standard Deviation 13.49

SECONDARY outcome

Timeframe: Baseline and 14 days after treatment

The Sino-nasal outcome test is a 22-item questionnaire completed by the patient or subject. Each item has a value of zero to five, a higher score indicates a self-perception of worse symptoms. The minimum score is zero and the maximum score is 110. The difference score here is the post-treatment score minus the pre-treatment score, with lower meaning more improvement

Outcome measures

Outcome measures
Measure	Oral Placebo With Nebulized Intranasal Levofloxacin n=9 Participants Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days oral levofloxacin nebulized levofloxacin	Oral Antibiotics With Nebulized Intranasal Placebo n=11 Participants Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. oral levofloxacin nebulized levofloxacin
Change in Sino-nasal Outcome Test (SNOT-22) Score	-2.333 units on a scale Standard Deviation 33.02	-18.73 units on a scale Standard Deviation 12.37

SECONDARY outcome

Timeframe: Baseline and 14 days after treatment

The Perioperative Sinus Endoscopy (POSE) instrument is a specific tool to endoscopically assess the sinus cavities of patients who have undergone endoscopic sinus surgery. Each POSE score has a minimum of 0 and a maximum of 16, with a higher score indicating a worse outcome. Here, the Left and Right POSE scores are summed and the difference between baseline and the 14 day after treatment is reported. The change in bilateral POSE score can in principle be -32 to +32, with increased scores indicating worse outcome and negative scores indicating improvement over the treatment period.

Outcome measures

Outcome measures
Measure	Oral Placebo With Nebulized Intranasal Levofloxacin n=9 Participants Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days oral levofloxacin nebulized levofloxacin	Oral Antibiotics With Nebulized Intranasal Placebo n=11 Participants Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. oral levofloxacin nebulized levofloxacin
Change in Bilateral Endoscopy Findings Using POSE Score	-2.889 units on a scale Standard Deviation 5.442	-4.545 units on a scale Standard Deviation 2.806

SECONDARY outcome

Timeframe: 14 days after treatment

Post-treatment culture negativity, defined as less than 1+ growth of organisms. A subject is counted '1' if both nares are free of bacterial growth, and '0' if growth is 1+ of more

Outcome measures

Outcome measures
Measure	Oral Placebo With Nebulized Intranasal Levofloxacin n=9 Participants Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days oral levofloxacin nebulized levofloxacin	Oral Antibiotics With Nebulized Intranasal Placebo n=11 Participants Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. oral levofloxacin nebulized levofloxacin
Number of Participants With Post-treatment Culture Negativity	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and 14 days after treatment

Population: Data was only collected on the first consecutive 8 randomized participants and had equal numbers in each group

The bacterial community was determined using a 16S rRNA quantitative PCR processed using Quantitative Insights into Microbial Ecology (QIIME) software, version 1.8 to yield the number of operational taxonomic units in each subject sample. The count has a minimum of zero with an increasing score indicating a larger number of distinct bacterial species.

Outcome measures

Outcome measures
Measure	Oral Placebo With Nebulized Intranasal Levofloxacin n=4 Participants Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days oral levofloxacin nebulized levofloxacin	Oral Antibiotics With Nebulized Intranasal Placebo n=4 Participants Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. oral levofloxacin nebulized levofloxacin
Mean Change in the Total Bacterial Community	17.40 operational taxonomic units Standard Deviation 9.530	6.700 operational taxonomic units Standard Deviation 7.404

Adverse Events

Oral Placebo With Nebulized Intranasal Levofloxacin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Oral Antibiotics With Nebulized Intranasal Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oral Placebo With Nebulized Intranasal Levofloxacin n=12 participants at risk Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days oral levofloxacin nebulized levofloxacin	Oral Antibiotics With Nebulized Intranasal Placebo n=13 participants at risk Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. oral levofloxacin nebulized levofloxacin
General disorders epistaxis	25.0% 3/12 • 6 months	46.2% 6/13 • 6 months
General disorders Fever	16.7% 2/12 • 6 months	0.00% 0/13 • 6 months
Gastrointestinal disorders diarrhea	8.3% 1/12 • 6 months	23.1% 3/13 • 6 months
Musculoskeletal and connective tissue disorders joint pain	0.00% 0/12 • 6 months	7.7% 1/13 • 6 months
Gastrointestinal disorders bad taste	25.0% 3/12 • 6 months	23.1% 3/13 • 6 months
Gastrointestinal disorders nausea/vomiting	8.3% 1/12 • 6 months	7.7% 1/13 • 6 months
General disorders dizziness	8.3% 1/12 • 6 months	0.00% 0/13 • 6 months

Additional Information

Research Program Manager

UR Medicine Otolaryngology

Phone: 5852751186

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Oral Placebo With Nebulized Intranasal Levofloxacin n=12 Participants Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days oral levofloxacin nebulized levofloxacin	Oral Antibiotics With Nebulized Intranasal Placebo n=13 Participants Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. oral levofloxacin nebulized levofloxacin	Total n=25 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	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	13 participants n=7 Participants	25 participants n=5 Participants