Phase 3
Completed N=25
Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations
Source: ClinicalTrials.gov NCT01988779 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Change in Rhinosinusitis Disability Index (RSDI) Score — -8.000; -14.82 units on a scale — p=0.505
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Rhinosinusitis Disability Index (RSDI) Score |
-8.000; -14.82 | 0.505 |
| SECONDARY Change in Sino-nasal Outcome Test (SNOT-22) Score |
-2.333; -18.73 | — |
| SECONDARY Change in Bilateral Endoscopy Findings Using POSE Score |
-2.889; -4.545 | 0.390 |
| SECONDARY Number of Participants With Post-treatment Culture Negativity |
5; 2 | 0.036 sig |
| SECONDARY Mean Change in the Total Bacterial Community |
17.40; 6.700 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01988779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.