Study of Nasal Irrigation Versus Nasal Spray for Chronic Nasal and Sinus Symptoms - Tabular View

Tracking Information

First Received Date ^ICMJE

April 21, 2006

Last Updated Date

August 30, 2006

Start Date ^ICMJE

December 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change in the mean score of the sinonasal outcome test-20
Change in medication usage for nasal and sinus symptoms

Original Primary Outcome Measures ^ICMJE

Change in the mean score of the Sino Nasal Outcomes test-20\
Change in medication usage for nasal and sinus symptoms

Change History

Complete list of historical versions of study NCT00318006 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Educational/Counseling/Training, Randomized, Open Label, Uncontrolled, Parallel Assignment

Condition ^ICMJE

Chronic Rhinosinusitis

Intervention ^ICMJE

Procedure: saline irrigation
Procedure: saline spray

Study Arms / Comparison Groups

Publications *

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

150

Completion Date

August 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00318006

Responsible Party

Study ID Numbers ^ICMJE

HUM00000253

Study Sponsor ^ICMJE

University of Michigan

Collaborators ^ICMJE

NeilMed Pharmaceuticals

Investigators ^ICMJE

Principal Investigator:

Melissa A Pynnonen, MD

University of Michigan

Information Provided By

University of Michigan

Verification Date

December 2005

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