Study of Nasal Irrigation Versus Nasal Spray for Chronic Nasal and Sinus Symptoms

Study Overview
=================
Brief Summary
-----------------
This study will compare nasal saline irrigation with nasal saline spray for the treatment of chronic nasal and sinus symptoms. Participants will complete a questionnaire regarding their nasal and sinus symptoms and will be randomly assigned to one of the treatment groups. Each participant will be instructed on how to perform daily nasal treatment.The subjects will complete follow-up surveys at regular intervals to assess any change in their nasal symptoms after starting nasal saline treatment. Participants may take their usual medications for sinus symptoms during their participation in the study.

Detailed Description
-----------------
See publication: Arch OtolaryngolHeadNeckSurg. 2007;133(11):1115-1120

Official Title
-----------------
A Randomized Study of Nasal Irrigation Versus Nasal Spray for Chronic Nasal and Sinus Symptoms

Conditions
-----------------
Chronic Rhinosinusitis

Intervention / Treatment
-----------------
* Procedure: saline irrigation
* Procedure: saline spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Presence of any one of the following symptoms for > 4 days/week and > 15 days in the past 1 month: Nasal stuffiness Nasal congestion Nasal dryness or crusting Abnormal nasal discharge Thick nasal discharge Exclusion Criteria: Functional endoscopic sinus surgery (FESS) in the last 3 months Epistaxis in the last 3 months that required treatment Acute illness like otitis media, laryngitis, pharyngitis, or rhinitis in the last 2 weeks Acute attack of asthma or bronchitis in the last 2 weeks Inability to speak or read English Current use of any of the study medications regularly for more than a week in the last 1 month Any history of intolerance to saline treatment (if used)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spray<br>subjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan). | Procedure: saline spray<br>* subjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan).<br>|
| Experimental: Irrigation<br>subjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan). | Procedure: saline irrigation<br>* subjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the mean score of the sinonasal outcome test-20 |  |  | 
| Change in medication usage for nasal and sinus symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic, nasal, sinus, symptoms