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

Information source: University of Michigan
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Rhinosinusitis

Intervention: saline irrigation (Procedure); saline spray (Procedure)

Phase: Phase 4

Status: Completed

Sponsored by: University of Michigan

Official(s) and/or principal investigator(s):
Melissa A Pynnonen, MD, Principal Investigator, Affiliation: University of Michigan

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.

Clinical Details

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

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

Primary outcome:

Change in the mean score of the sinonasal outcome test-20

Change in medication usage for nasal and sinus symptoms

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

University of Michigan Health System, Ann Arbor, Michigan 48109, United States
Additional Information

Starting date: December 2005
Last updated: January 28, 2015

Page last updated: August 20, 2015

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