SinuSurf vs. Saline Solution in Normal Subjects
NCT02728505 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2017-03-14
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.
Conditions
- Rhinosinusitis
Interventions
- DRUG
-
SinuSurf irrigation twice daily
- DRUG
-
NeilMed Sinus rinse irrigation twice daily
Sponsors & Collaborators
-
NeilMed Pharmaceuticals
collaborator INDUSTRY -
Vanderbilt University Medical Center
lead OTHER
Principal Investigators
-
Justin Turner, MD, PhD · Vanderbilt University Medical Center
-
Rakesh K. Chandra, MD · Vanderbilt University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-04-12
- Primary Completion
- 2017-01-20
- Completion
- 2017-01-20
Countries
- United States
Study Locations
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