Study of Nasal Irrigation Versus Nasal Spray for Chronic Nasal and Sinus Symptoms
NCT ID: NCT00318006
Last Updated: 2015-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
127 participants
INTERVENTIONAL
2005-12-31
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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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).
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).
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 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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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NeilMed Pharmaceuticals
INDUSTRY
University of Michigan
OTHER
Responsible Party
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Melissa Pynnonen
Associate Professor of Otolaryngology
Principal Investigators
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Melissa A Pynnonen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan Health System
Ann Arbor, Michigan, United States
Countries
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References
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Pynnonen MA, Mukerji SS, Kim HM, Adams ME, Terrell JE. Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. Arch Otolaryngol Head Neck Surg. 2007 Nov;133(11):1115-20. doi: 10.1001/archotol.133.11.1115.
Related Links
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Related Info
Other Identifiers
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HUM00000253
Identifier Type: -
Identifier Source: org_study_id
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