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Completed

NCT Number: NCT00318006

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.

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Key information

Conditions

Chronic Rhinosinusitis Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Fistula Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Saline irrigation

Procedure

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).

saline spray

Procedure

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).

Primary outcomes

  1. Change in the mean score of the sinonasal outcome test-20

  2. Change in medication usage for nasal and sinus symptoms

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • NeilMed Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 25, 2006
Registry last updated
Jan 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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