SinuSurf vs. Saline Solution in Normal Subjects

• Status: Completed
• Trial end date: 2017-01-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: NeilMed Pharmaceuticals
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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.