Clinical trial NCT01030146: Management of Allergic Rhinitis Patients With Nasal Steroids and NeilMed® Sinus Rinse™ System With Isotonic Saline
Official title: Management of Allergic Rhinitis Patients With Nasal Steroids and NeilMed® Sinus Rinse™ System With Isotonic Saline: A Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinitis
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: NeilMed Pharmaceuticals
First posted: 2009-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: mRQLQ
timeFrame: 8 weeks
Secondary outcomes:
measure: Nasal Peak Inspiratory Flow
timeFrame: 8 weeks
measure: Safety and Adverse Effects
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Sinus Center - Medical Univesity of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Rodney J Schlosser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Shaun A Nguyen, M.D.,CPI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.