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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
NeilMed Pharmaceuticals
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00318006
First received: April 21, 2006
Last updated: August 30, 2006
Last verified: December 2005
  Purpose

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.


Condition Intervention Phase
Chronic Rhinosinusitis
Procedure: saline irrigation
Procedure: saline spray
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: A Randomized Study of Nasal Irrigation Versus Nasal Spray for Chronic Nasal and Sinus Symptoms

Resource links provided by NLM:


Further study details as provided by University of Michigan:

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

Estimated Enrollment: 150
Study Start Date: December 2005
Estimated Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318006

Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
NeilMed Pharmaceuticals
Investigators
Principal Investigator: Melissa A Pynnonen, MD University of Michigan
  More Information

Additional Information:
No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00318006     History of Changes
Other Study ID Numbers: HUM00000253
Study First Received: April 21, 2006
Last Updated: August 30, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
chronic
nasal
sinus
symptoms

Additional relevant MeSH terms:
Ephedrine
Pseudoephedrine
Adrenergic Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Stimulants
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 25, 2014