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

Overview

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.

Full Title of Study: “A Randomized Study of Nasal Irrigation Versus Nasal Spray for Chronic Nasal and Sinus Symptoms”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2006

Detailed Description

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

Interventions

  • Procedure: 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).
  • Procedure: 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).

Arms, Groups and Cohorts

  • Active Comparator: 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).
  • Experimental: 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).

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Michigan
  • Collaborator
    • NeilMed Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Principal Investigator: Melissa Pynnonen, Associate Professor of Otolaryngology – University of Michigan
  • Overall Official(s)
    • Melissa A Pynnonen, MD, Principal Investigator, University of Michigan

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