Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations
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ClinicalTrials.gov Identifier: NCT01988779 |
Recruitment Status :
Completed
First Posted : November 20, 2013
Results First Posted : December 11, 2019
Last Update Posted : March 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Rhinosinusitis | Drug: oral levofloxacin Drug: nebulized levofloxacin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations |
Actual Study Start Date : | October 2013 |
Actual Primary Completion Date : | September 11, 2017 |
Actual Study Completion Date : | December 31, 2020 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 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
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Drug: oral levofloxacin Drug: nebulized levofloxacin |
Active Comparator: 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.
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Drug: oral levofloxacin Drug: nebulized levofloxacin |
- Change in Rhinosinusitis Disability Index (RSDI) Score [ Time Frame: Baseline and 14 days after treatment ]
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
- Change in Sino-nasal Outcome Test (SNOT-22) Score [ Time Frame: 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
- Change in Bilateral Endoscopy Findings Using POSE Score [ Time Frame: 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.
- Number of Participants With Post-treatment Culture Negativity [ Time Frame: 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
- Mean Change in the Total Bacterial Community [ Time Frame: Baseline and 14 days after treatment ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults (age ≥ 18).
- Diagnosis of CRS.
- Worsening sinonasal symptoms.
- Previous bilateral endoscopic sinus surgery (ESS) (including maxillary antrostomy and anterior ethmoidectomy).
- English speaking.
- Open sinuses (open middle meatus bilaterally; determined on endoscopy).
- Positive sinonasal culture (1+ or greater) with sensitivity to one of the pre-chosen antibiotic regimens.
Exclusion Criteria:
- Patients < 18 years of age.
- Treatment with systemic or topical antibiotics within the last 1 month.
- Pregnant women.
- Non-English speaking persons.
- Systemically ill at initial visit necessitating treatment prior to culture data.
- Allergies to chosen susceptible antibiotics.
- Sinonasal culture with less than 1+ growth.
- Multiple organisms grown on culture that are not sensitive to a single antibiotic.
- Patients with ciliary function disorders (cystic fibrosis, Kartagener's syndrome, ciliary dyskinesia).
- Patients with immunodeficiencies.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988779
United States, New York | |
University of Rochester Department of Otolaryngology Head and Neck Surgery | |
Rochester, New York, United States, 14642 |
Principal Investigator: | Li-Xing Man, MD, MPA, Msc | University of Rochester |
Documents provided by Li-Xing Man, University of Rochester:
Responsible Party: | Li-Xing Man, M.D., University of Rochester |
ClinicalTrials.gov Identifier: | NCT01988779 |
Other Study ID Numbers: |
45566 |
First Posted: | November 20, 2013 Key Record Dates |
Results First Posted: | December 11, 2019 |
Last Update Posted: | March 24, 2021 |
Last Verified: | March 2021 |
Levofloxacin Ofloxacin Sinusitis Respiratory Tract Infections Infections Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Anti-Infective Agents, Urinary |
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