NCT01030146

Brief Summary

You are being asked to volunteer for a research study. You are being asked to participate in this study because you have completed at least one month of drug treatment with a nasal steroid and allergy testing and still have symptoms. This research study is sponsored by NeilMed Pharmaceuticals, Inc. The purpose of this study is to compare quality of life outcomes in patients who continue medical treatment plus the use of the NeilMed Sinus Rinse low-pressure pump with saline. Your participation in this study may help to improve the management of patients with allergic rhinitis. Allergic rhinitis is a common health problem, affecting between 10% and 40% of the world's population. Presently, antihistamines and nasal steroids are the standard treatment for allergic rhinitis. To further clarify these findings, we propose a study comparing the differences in quality of life improvements, by using a series of questionnaires, between subjects electing continued medical management and those electing medical treatment plus nasal wash. The investigators in charge of the study are Dr. Rodney J. Schlosser and Dr. Shaun A. Nguyen. Approximately 40 patients will be enrolled in this study at the Medical University of South Carolina (MUSC Hospital). You will have the choice of choosing either to receive only medical treatment or to receive medical treatment with nasal wash.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

December 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 23, 2018

Status Verified

August 1, 2014

Enrollment Period

3.5 years

First QC Date

December 9, 2009

Last Update Submit

July 19, 2018

Conditions

Rhinitis

Outcome Measures

Primary Outcomes (1)

  • mRQLQ

    8 weeks

Secondary Outcomes (2)

  • Nasal Peak Inspiratory Flow

    8 weeks

  • Safety and Adverse Effects

    8 weeks

Study Arms (1)

NeilMed® Sinus Rinse™ System

OTHER

NeilMed® Sinus Rinse™ System with Isotonic Saline twice a day

Drug: NeilMed® Sinus Rinse™ System with Isotonic Saline

Interventions

NeilMed® Sinus Rinse™ System with Isotonic SalineDRUG

NeilMed® Sinus Rinse™ System with Isotonic Saline twice a day

NeilMed® Sinus Rinse™ System

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female adults (aged 18-99) diagnosed with rhinitis who have completed one month of pharmacotherapy exclusively with nasal steroids and allergy testing.

You may not qualify if:

  • male and female adults who have been diagnosed with sinusitis, cystic fibrosis, or immune deficiency or those unable or unwilling to perform saline irrigations for two months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinus Center - Medical Univesity of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

  • Nguyen SA, Camilon MP, Schlosser RJ. Identification of microbial contaminants in sinus rinse squeeze bottles used by allergic rhinitis patients. World J Otorhinolaryngol Head Neck Surg. 2019 Jan 5;5(1):26-29. doi: 10.1016/j.wjorl.2018.12.001. eCollection 2019 Mar.

    PMID: 30775698DERIVED

  • Nguyen SA, Psaltis AJ, Schlosser RJ. Isotonic saline nasal irrigation is an effective adjunctive therapy to intranasal corticosteroid spray in allergic rhinitis. Am J Rhinol Allergy. 2014 Jul-Aug;28(4):308-11. doi: 10.2500/ajra.2014.28.4066. Epub 2014 May 22.

    PMID: 24857280DERIVED

Related Links

MeSH Terms

Conditions

Rhinitis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Rodney J Schlosser, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Shaun A Nguyen, M.D.,CPI

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 11, 2009

Study Start

December 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 23, 2018

Record last verified: 2014-08

Locations

US(1)