Sinusitis Clinical Trial
— QSINDOfficial title:
Efficacy and Safety of Adjuvant Topical Irrigation in the Treatment of Acute Exacerbation of Chronic Rhinosinusitis Following Functional Endoscopic Sinus Surgery (FESS)
Verified date | February 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to evaluate the physiologic response of quinine-saline irrigations for acute exacerbation of uncomplicated chronic rhinosinusitis following endoscopic sinus surgery. Subjects who have previously had functional endoscopic sinus surgery with acute exacerbation of chronic rhinosinusitis will be randomized to either a quinine-saline or saline-placebo arm. The investigators will measure baseline and follow-up clinical and quality-of-life outcomes for both arms, and then compare the groups at the end of the study period. The investigators' hypothesis is that the participants in the quinine sulfate arm will perform better on all measures as compared to the control arm.
Status | Terminated |
Enrollment | 10 |
Est. completion date | May 4, 2017 |
Est. primary completion date | May 4, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients who have undergone Functional Endoscopic Sinus Surgery (FESS) 2. Purulent drainage on nasal endoscopy 3. Male or female subjects, 18 years of age or older 4. Patients seen at the Dept. of Otorhinolaryngology clinic at Hospital of the University of Pennsylvania (HUP), a tertiary care clinic Exclusion Criteria: 1. Pregnant women 2. Immunocompromised patients 3. Granulomatous diseases with rhinologic manifestations (Wegner's, Sarcoid, Churg-Strauss) 4. Primary ciliary dyskinesia |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rescue Antibiotics | The necessity for rescue oral antibiotics for persistent infection. | Week 2 and Week 10 | |
Primary | Change in Microbiome Profile | Pre and post treatment endoscopically-obtained sinonasal microbiologic cultures. | Baseline, Week 2, and Week 10 | |
Secondary | Change in Lund-Kennedy Endoscope Score | Pre and post treatment nasal endoscopy scored with a validated staging system for edema, -scored by an independent blind observer. | Baseline, Week 2, and Week 10 | |
Secondary | Change in the 22-item Sinonasal Outcomes Test Score | Pre and post treatment quality of life questionnaires (22-item Sinonasal Outcomes Test [SNOT-22]). | Baseline, Week 2, and Week 10 | |
Secondary | Change in Sniffin' Stick-12 Score | Change in olfactory sense from baseline to week 10 will be measured using the Sniffin' Stick-12 system. Patients will smell each "sniffing pen" and record the smell they detect. A score between 0-12 will indicate olfactory sense. | Baseline, Week 2 and Week 10 |
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