Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

NCT01988779 | Completed Phase 3 Results

• 1 other identifier: 45566
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily intranasal antibiotic irrigations. The two treatments will be compared to see if there is any difference in patient outcomes. This will help guide treatment strategies for patients with CRS in the future.

Conditions

Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Change in Rhinosinusitis Disability Index (RSDI) Score

  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

  Baseline and 14 days after treatment

Secondary Outcomes (4)

• Change in Sino-nasal Outcome Test (SNOT-22) Score

  Baseline and 14 days after treatment

• Change in Bilateral Endoscopy Findings Using POSE Score

  Baseline and 14 days after treatment

• Number of Participants With Post-treatment Culture Negativity

  14 days after treatment

• Mean Change in the Total Bacterial Community

  Baseline and 14 days after treatment

Study Arms (2)

oral placebo with nebulized intranasal levofloxacin

ACTIVE COMPARATOR

Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days

Drug: oral levofloxacin; Drug: nebulized levofloxacin

oral antibiotics with nebulized intranasal placebo

ACTIVE COMPARATOR

Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days.

Drug: oral levofloxacin; Drug: nebulized levofloxacin

Interventions

oral levofloxacin DRUG

oral antibiotics with nebulized intranasal placebo; oral placebo with nebulized intranasal levofloxacin

nebulized levofloxacin DRUG

oral antibiotics with nebulized intranasal placebo; oral placebo with nebulized intranasal levofloxacin

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Department of Otolaryngology Head and Neck Surgery

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Levofloxacin

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Research Program Manager
• Organization: UR Medicine Otolaryngology

paul_allen@urmc.rochester.edu

5852751186

Study Officials

• Li-Xing Man, MD, MPA, Msc

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 20, 2013
• Study Start: October 1, 2013
• Primary Completion: September 11, 2017
• Study Completion: December 31, 2020
• Last Updated: March 24, 2021
• Results First Posted: December 11, 2019

Record last verified: 2021-03

Locations

US (1)