Nasal Lavage Study: Comparing Single Versus Multi Sample Lavages
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|ClinicalTrials.gov Identifier: NCT00229190|
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : April 24, 2007
|First Submitted Date ICMJE||September 27, 2005|
|First Posted Date ICMJE||September 29, 2005|
|Last Update Posted Date||April 24, 2007|
|Study Start Date ICMJE||September 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Eosinophil per cent of cells recovered in lavage fluid|
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
||Albumen concentration in lavage fluid|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Nasal Lavage Study: Comparing Single Versus Multi Sample Lavages|
|Official Title ICMJE||Reproducibility of Cell Counts in Nasal Lavage: A Comparison of Pooled Versus Non-Pooled Nasal Lavage Samples|
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.
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 Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Study Arms ICMJE||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Actual Study Completion Date ICMJE||May 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages ICMJE||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT00229190|
|Other Study ID Numbers ICMJE||04-227
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Hamilton Health Sciences Corporation|
|Collaborators ICMJE||Firestone Institute for Respiratory Health|
|PRS Account||McMaster University|
|Verification Date||April 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP