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

Chronic Rhinosinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318006
• Other study ID #: HUM00000253
• Status: Completed
• Phase: Phase 4
• First received: April 21, 2006
• Last updated: January 28, 2015
• Start date: December 2005
• Est. completion date: August 2006

Study information

• Verified date: January 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: August 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Rhinosinusitis

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	NeilMed Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the mean score of the sinonasal outcome test-20
Primary	Change in medication usage for nasal and sinus symptoms

External Links

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