NCT02728505

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

April 12, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2017

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

March 30, 2016

Last Update Submit

March 10, 2017

Conditions

Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

  • Sense of smell assessed by change in UPSIT-40 score between when subjects use SinuSurf, as compared to saline control.

    5 weeks

Secondary Outcomes (1)

  • Tolerability

    5 weeks

Study Arms (2)

SinuSurf irrigation twice daily

ACTIVE COMPARATOR

This arm is going to get low-concentration SinuSurf sinus irrigation solution, then a washout period, then standard NeilMed Sinus rinse.

Drug: SinuSurf irrigation twice dailyDrug: NeilMed Sinus rinse irrigation twice daily

NeilMed Sinus rinse irrigation twice daily

PLACEBO COMPARATOR

This arm is going to get standard NeilMed Sinus rinse, then a washout period, then low-concentration SinuSurf sinus irrigation solution.

Drug: SinuSurf irrigation twice dailyDrug: NeilMed Sinus rinse irrigation twice daily

Interventions

SinuSurf irrigation twice dailyDRUG
NeilMed Sinus rinse irrigation twice dailySinuSurf irrigation twice daily
NeilMed Sinus rinse irrigation twice dailyDRUG
NeilMed Sinus rinse irrigation twice dailySinuSurf irrigation twice daily

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

RhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Justin Turner, MD, PhD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

  • Rakesh K. Chandra, MD

    Vanderbilt University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 5, 2016

Study Start

April 12, 2016

Primary Completion

January 20, 2017

Study Completion

January 20, 2017

Last Updated

March 14, 2017

Record last verified: 2017-03

Locations

US(1)