Management of Allergic Rhinitis Patients With Nasal Steroids and NeilMed® Sinus Rinse™ System With Isotonic Saline

July 19, 2018 updated by: Medical University of South Carolina

Management of Allergic Rhinitis Patients With Nasal Steroids and NeilMed® Sinus Rinse™ System With Isotonic Saline: A Prospective Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before you are allowed to participate in this study, the doctor will review your medical history and ask you questions to see if you qualify for the study.

This study follows the standard of care in managing patients with allergic rhinitis. You will undergo allergy testing with the skin prick test (SPT), a baseline NPIF (Nasal Peak Inspiratory Flow, where we ask you to breath in a mask) measurement, and a baseline assessment with the mRQLQ (Mini Rhinoconjunctivitis Quality of Life Questionnaire) questionnaire. You will be asked to continue drug treatment with nasal steroid along with the NeilMed Sinus Rinse low-pressure pump with isotonic saline as an add-on treatment. You will be given supplies and instructions on the use of the NeilMed Sinus Rinse low-pressure pump with saline to be performed twice a day for two months. You will be asked to come back at the end of 1 month and 2 months, where you will complete another mRQLQ and NPIF assessment. In addition, you will be asked to return low-pressure nasal irrigation bottle for testing of bacteria and fungi at the end of 1 month and 2 months. This is a safety assessment for back wash contamination.

If you are unable to return for scheduled clinic visits, questionnaires will be mailed with self-addressed stamped envelopes with follow-up phone calls to ensure study compliance and minimal attrition C. Duration The time to answer the survey questionnaires will take no longer than 20 minutes on each visit. The entire duration of the study is no longer than 8 weeks

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Sinus Center - Medical Univesity of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: NeilMed® Sinus Rinse™ System
NeilMed® Sinus Rinse™ System with Isotonic Saline twice a day
Drug: NeilMed® Sinus Rinse™ System with Isotonic Saline
NeilMed® Sinus Rinse™ System with Isotonic Saline twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mRQLQ
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Nasal Peak Inspiratory Flow
Time Frame: 8 weeks
8 weeks
Safety and Adverse Effects
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

NeilMed Pharmaceuticals

Investigators

  • Principal Investigator: Rodney J Schlosser, MD, Medical University of South Carolina
  • Principal Investigator: Shaun A Nguyen, M.D.,CPI, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (Estimate)

December 11, 2009

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sinus Rinse

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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