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

Phase 4

Completed

• Conditions: Chronic Rhinosinusitis
• Interventions: Procedure: saline irrigation; Procedure: saline spray

• Registration Number: NCT00318006
• Lead Sponsor: University of Michigan

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

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-04-21
• Study First Submitted QC: 2006-04-21
• Study First Posted: 2006-04-25
• Primary Completion: 2006-07
• Study Completion: 2006-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-28
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irrigation	saline 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).
Spray	saline 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).

Primary Outcome Measures

Name	Time	Method
Change in the mean score of the sinonasal outcome test-20
Change in medication usage for nasal and sinus symptoms

Trial Locations

Locations (1)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States