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

This study has been completed.
Sponsor:
Collaborator:
NeilMed Pharmaceuticals
Information provided by (Responsible Party):
Shaun A. Nguyen, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01030146
First received: December 9, 2009
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Rhinitis
Drug: NeilMed® Sinus Rinse™ System with Isotonic Saline

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Allergic Rhinitis Patients With Nasal Steroids and NeilMed® Sinus Rinse™ System With Isotonic Saline: A Prospective Pilot Study

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • mRQLQ [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nasal Peak Inspiratory Flow [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Safety and Adverse Effects [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: December 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: NeilMed® Sinus Rinse™ System with Isotonic Saline

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030146

Locations
United States, South Carolina
Sinus Center - Medical Univesity of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
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
  More Information

Additional Information:
PubMed  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Shaun A. Nguyen, Associate Professor - Director of Clinical Reserach, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01030146     History of Changes
Other Study ID Numbers: Sinus Rinse
Study First Received: December 9, 2009
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014