Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229190
Status:
COMPLETED
Last Update Posted:
2007-04-24
First Post:
2005-09-27
Brief Title:
Nasal Lavage Study Comparing Single Versus Multi Sample Lavages
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
Reproducibility of Cell Counts in Nasal Lavage A Comparison of Pooled Versus Non-Pooled Nasal Lavage Samples
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg runny nose congestion sneezing post nasal drip and in individuals without nasal symptoms
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 eg runny nose congestion sneezing post nasal drip and in individuals without nasal symptoms
Detailed 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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 200311 | None | None | None |