Chronic Rhinosinusitis
Conditions
Keywords
chronic, nasal, sinus, symptoms
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
Interventions
PROCEDUREsaline irrigation
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).
PROCEDUREsaline spray
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).
Sponsors
NeilMed Pharmaceuticals
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the mean score of the sinonasal outcome test-20 | — |
| Change in medication usage for nasal and sinus symptoms | — |
Countries
United States
Outcome results
None listed