SinuSurf vs. Saline Solution in Normal Subjects

Completed · Phase 1

Conditions studied: Rhinosinusitis

In brief

Single-center, prospective, placebo controlled trial of tolerability and safety of low-concentration SinuSurf sinus irrigation solution in normal subjects. Forty (40) healthy subjects aged 18-65 will be enrolled in the study.

Key facts

Study ID

NCT02728505

Run by

Vanderbilt University Medical Center

People needed

40

Starts

2016-04-12

Expected to finish

2017-01-20

Last updated by the study team

2017-03-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Individuals aged 18-65 with no sinonasal symptoms who are normosmic (as determined by UPSIT-40) and have normal anterior rhinoscopy.

You may not qualify if…

• Any symptom or sign of active nasal or sinus disease from UPSIT-40 or exam of ears and nose.
• UPSIT-40result that is not normosmic.
• Cystic fibrosis.
• Immunosuppression from disease or therapy (HIV, primary immune deficiency, diabetes, renal insufficiency, organ transplant, immune suppressive drug).
• History of previous Endoscopic Sinus Surgery or nasal surgery.
• Not willing to use contraception or abstain from sexual relations during trial period.
• Any woman who is currently pregnant.

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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