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

First Received on April 21, 2006. Last Updated on August 30, 2006 History of Changes

Sponsor:	University of Michigan
Collaborator:	NeilMed Pharmaceuticals
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00318006

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 IV

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:

Drug Information available for: Ephedrine Hydrochloride Ephedrine Pseudoephedrine hydrochloride Pseudoephedrine Sulfate

U.S. FDA Resources

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

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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

Vasoconstrictor Agents
Cardiovascular Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Respiratory System Agents
Bronchodilator Agents
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on February 09, 2012