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

This study has been completed.
Sponsor:
Collaborator:
NeilMed Pharmaceuticals
Information provided by (Responsible Party):
Melissa Pynnonen, University of Michigan
ClinicalTrials.gov Identifier:
NCT00318006
First received: April 21, 2006
Last updated: January 28, 2015
Last verified: January 2015

April 21, 2006
January 28, 2015
December 2005
July 2006   (final data collection date for primary outcome measure)
  • Change in the mean score of the sinonasal outcome test-20
  • Change in medication usage for nasal and sinus symptoms
  • Change in the mean score of the Sino Nasal Outcomes test-20\
  • Change in medication usage for nasal and sinus symptoms
Complete list of historical versions of study NCT00318006 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Nasal Irrigation Versus Nasal Spray for Chronic Nasal and Sinus Symptoms
A Randomized Study of Nasal Irrigation Versus Nasal Spray for Chronic Nasal and Sinus Symptoms

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Chronic Rhinosinusitis
  • 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).
  • 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).
    Intervention: Procedure: saline spray
  • 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).
    Intervention: Procedure: saline irrigation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
August 2006
July 2006   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00318006
HUM00000253
Not Provided
Melissa Pynnonen, University of Michigan
University of Michigan
NeilMed Pharmaceuticals
Principal Investigator: Melissa A Pynnonen, MD University of Michigan
University of Michigan
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP