NCT00318006

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

7 months

First QC Date

April 21, 2006

Last Update Submit

January 28, 2015

Conditions

Chronic Rhinosinusitis

Keywords

chronicnasalsinussymptoms

Outcome Measures

Primary Outcomes (2)

  • Change in the mean score of the sinonasal outcome test-20

  • Change in medication usage for nasal and sinus symptoms

Study Arms (2)

Spray

ACTIVE COMPARATOR

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

Irrigation

EXPERIMENTAL

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 irrigation

Interventions

saline irrigationPROCEDURE

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
saline sprayPROCEDURE

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).

Spray

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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.

    PMID: 18025315DERIVED

Related Links

MeSH Terms

Conditions

Bronchiolitis Obliterans SyndromeFistula

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Melissa A Pynnonen, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Otolaryngology

Study Record Dates

First Submitted

April 21, 2006

First Posted

April 25, 2006

Study Start

December 1, 2005

Primary Completion

July 1, 2006

Study Completion

August 1, 2006

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

US(1)