Nasal Lavage Study: Comparing Single Versus Multi Sample Lavages

Reproducibility of Results Clinical Trial

Official title: Reproducibility of Cell Counts in Nasal Lavage: A Comparison of Pooled Versus Non-Pooled Nasal Lavage Samples

Status Completed

Clinical Trial Summary

Nasal lavage could be an integral component of assessing airway inflammation. Research into the reproducibility of cell counts is key to understanding the value of lavage results.

The objective of this study is to evaluate and compare the reproducibility of a common nasal lavage technique and its variation in a sample of subjects with nasal symptoms (e.g. runny nose, congestion, sneezing, post nasal drip), and in individuals without nasal symptoms.

Clinical Trial Description

Nasal lavage is a relatively simple way to measure the degree of upper airway inflammation. It is useful in research because it is noninvasive, relatively discomfort-free, and simple to perform. Yet there is no standardized method for collecting upper airway cells. The definition of nasal lavage can differ widely between research groups. The method, and its pooled modification, chosen for this trial are based on the commonly used Naclerio technique.

Upper airway inflammation is linked to a broad spectrum of disease: nasal polyposis, seasonal and perennial allergic rhinitis, vasomotor or non-allergic rhinitis, and sinusitis. Assessing the degree of upper airway inflammation through objective measures has obvious clinical and research benefits. For example, nasal polyps contain a large number of activated eosinophils - about 20% of the constituents of nasal polyp tissue. Allergic rhinitis is also associated with elevated inflammatory cell counts - eosinophils, basophils, mast cells, lymphocytes and their mediators. The impact of treatment on nasal inflammation is a key factor in the evaluation of new nasal polyp or allergic rhinitis therapies. Therefore it is imperative that nasal inflammation measurements be evaluated for reliability.

As nasal inflammation is present in a variety of diseases, a cross section of subjects will be enrolled in this trial. Nasal lavages will be performed on nasal polyp subjects, perennial allergic rhinitis subjects, and normal subjects. This project will assess the repeatability of a single sample lavage in comparison to the repeatability of a modified version, i.e. a lavage sample conducted three times, 15 minutes apart, and then pooled, or combined. We expect to find the highest eosinophil counts in patients with nasal polyposis, intermediate levels in patients with perennial allergic rhinitis and low levels in normal subjects, based on previous work.

This project will be a single-centre, randomized trial involving three sets of seven subjects - polyp subjects, perennial allergic rhinitis subjects, and normals. All subjects will be blinded to the assessment of outcome measurements.

The study will be comprised of four clinic appointments. Appointments will be scheduled seven to 10 days apart. All subjects will be randomly assigned their lavage sampling group at their baseline visit. Group one will consist of a single sample lavage at visit one, a multiple sample lavage at visit two, a single sample lavage at visit three, and a multiple sample lavage a visit four. Group two will be the reverse order. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Eosinophils
• Nasal Lavage Fluid
• Reproducibility of Results

• NCT number: NCT00229190
• Study type: Interventional
• Source: McMaster University
• Status: Completed
• Phase: N/A
• Start date: September 2004
• Completion date: May 2005