Management of Allergic Rhinitis Patients With Nasal Steroids and NeilMed® Sinus Rinse™ System With Isotonic Saline
Condition: Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

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
    

Intervention name(s): NeilMed® Sinus Rinse™ System with Isotonic Saline
Intervention type(s): Drug
Intervention description(s): NeilMed® Sinus Rinse™ System with Isotonic Saline twice a day
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment