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
NCT number | NCT01030146 |
Other study ID # | Sinus Rinse |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2009 |
Est. completion date | June 2013 |
Verified date | August 2014 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Sinus Center - Medical Univesity of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | NeilMed Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mRQLQ | 8 weeks | ||
Secondary | Nasal Peak Inspiratory Flow | 8 weeks | ||
Secondary | Safety and Adverse Effects | 8 weeks |
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