Rhinitis Clinical Trial
Official title:
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.
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
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