University of Rochester Department of Otolaryngology Head and Neck Surgery
Rochester, New York, 14642, United States
NCT Number: NCT01988779
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Rochester, New York, 14642, United States
See brief summary.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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
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.
University of Rochester
Other
Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations
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