Nasal Lavage FluidNCT00229190
Nasal Lavage Study: Comparing Single Versus Multi Sample Lavages
A study testing Nasal lavage, Allergy skin testing and Peak nasal inspiratory flow in people with Nasal Lavage Fluid and Eosinophils, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Lavage Fluid, Eosinophils, Reproducibility of Results
- What is being tested?
- Nasal lavage, Allergy skin testing and Peak nasal inspiratory flow
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2004to May 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is male or female aged 18 years or older.
- Subject understands the research project and agrees to participate by signing an informed consent agreement.
- Subject is able to successfully complete nasal lavage training session.
Who cannot join
- Subjects with severe nasal polyps which prevent collecting adequate nasal lavage sample.
- Subjects who have undergone surgery to treat their nasal polyps (nasal polypectomy) within one year prior to visit one
- Subjects who have a known fungal infection of the nose and/or paranasal sinuses, nasal candidiasis, acute or chronic infectious sinusitis of viral or bacterial nature.
- Subjects who have had an upper respiratory tract infection within four weeks prior to visit one.
- Subjects having cystic fibrosis, Young's syndrome, primary ciliary dyskinesia, known HIV infection or alcohol abuse.
- Subjects with clinically significant, uncontrolled evidence of cardiovascular, neurological, hepatic, renal, respiratory, or any other medical condition that may interfere with the study.
Show all 13Show fewer
- Subjects with a recent history (within six months) of a clinically significant psychiatric disorder other than mild depression.
- Subjects who have any clinically relevant deviation from normal in the general physical examination.
- Subjects who have received any depot, systemic or oral corticosteroid in the previous three months prior to the start of the study.
- Subjects who are using an intranasal steroid or antihistamine for their nasal symptoms and are unable to remain on a constant dose for four weeks prior to visit 1 or for the duration of the study.
- Females who are pregnant or lactating or are likely to become pregnant during the study or are less than 8 weeks postpartum. Women of childbearing age may be included if, in the opinion of the investigator, they are taking adequate contraceptive measures.
- Subjects who are unable to follow the instructions within this protocol or known inability to attend all clinic visits within the intervals stated.
- Subjects who have participated in a clinical trial involving an investigational or marketed drug within four weeks of visit one.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences Corporation, McMaster Site
Hamilton, Ontario, L8N 3Z5
About this study
Official title: 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.
Read the 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, 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.
- Conditions
- Nasal Lavage Fluid, Eosinophils, Reproducibility of Results
- Being tested
- Nasal lavage, Allergy skin testing, Peak nasal inspiratory flow, Acoustic rhinometry, Nasal examination
- Keywords
- Nasal lavage fluid, Eosinophils, Reproducibility of results
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal lavageProcedure or surgery
Allergy skin testingProcedure or surgery
Peak nasal inspiratory flowProcedure or surgery
Acoustic rhinometryProcedure or surgery
Nasal examinationProcedure or surgery
Quality of Life QuestionnaireProcedure or surgery
Physical examinationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Eosinophil per cent of cells recovered in lavage fluid
Secondary outcomes (1)
Albumen concentration in lavage fluid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startSep 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Nasal Lavage FluidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Firestone Institute for Respiratory Health
- Investigators
- Paul Keith, MD MSc FRCPC, Principal investigator, Hamilton Health Sciences Corporation, McMaster Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229190
- Sponsor's protocol ID
- 04-227
- Other IDs
- 2003/11
- Status last verified
- Apr 2007
- First submitted
- 27 Sep 2005
- Last updated
- 24 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Naclerio RM, Meier HL, Kagey-Sobotka A, Adkinson NF Jr, Meyers DA, Norman PS, Lichtenstein LM. Mediator release after nasal airway challenge with allergen. Am Rev Respir Dis. 1983 Oct;128(4):597-602. doi: 10.1164/arrd.1983.128.4.597.
PubMed 6354022Finotto S, Dolovich J, Denburg JA, Jordana M, Marshall JS. Functional heterogeneity of mast cells isolated from different microenvironments within nasal polyp tissue. Clin Exp Immunol. 1994 Feb;95(2):343-50. doi: 10.1111/j.1365-2249.1994.tb06535.x.
PubMed 7508349Koren HS, Hatch GE, Graham DE. Nasal lavage as a tool in assessing acute inflammation in response to inhaled pollutants. Toxicology. 1990 Jan-Feb;60(1-2):15-25. doi: 10.1016/0300-483x(90)90159-e.
PubMed 2315937Miadonna A, Milazzo N, Gibelli S, Salmaso C, Lorini M, Tedeschi A. Nasal response to a single antigen challenge in patients with allergic rhinitis - inflammatory cell recruitment persists up to 48 hours. Clin Exp Allergy. 1999 Jul;29(7):941-9. doi: 10.1046/j.1365-2222.1999.00609.x.
PubMed 10383595Noah TL, Henderson FW, Henry MM, Peden DB, Devlin RB. Nasal lavage cytokines in normal, allergic, and asthmatic school-age children. Am J Respir Crit Care Med. 1995 Oct;152(4 Pt 1):1290-6. doi: 10.1164/ajrccm.152.4.7551384.
PubMed 7551384Nikasinovic-Fournier L, Just J, Seta N, Callais F, Sahraoui F, Grimfeld A, Momas I. Nasal lavage as a tool for the assessment of upper-airway inflammation in adults and children. J Lab Clin Med. 2002 Mar;139(3):173-80. doi: 10.1067/mlc.2002.121661.
PubMed 11944028Belda J, Parameswaran K, Keith PK, Hargreave FE. Repeatability and validity of cell and fluid-phase measurements in nasal fluid: a comparison of two methods of nasal lavage. Clin Exp Allergy. 2001 Jul;31(7):1111-5. doi: 10.1046/j.1365-2222.2001.01133.x.
PubMed 11468003Greiff L, Pipkorn U, Alkner U, Persson CG. The 'nasal pool' device applies controlled concentrations of solutes on human nasal airway mucosa and samples its surface exudations/secretions. Clin Exp Allergy. 1990 May;20(3):253-9. doi: 10.1111/j.1365-2222.1990.tb02680.x.
PubMed 2364306Hauser R, Garcia-Closas M, Kelsey KT, Christiani DC. Variability of nasal lavage polymorphonuclear leukocyte counts in unexposed subjects: its potential utility for epidemiology. Arch Environ Health. 1994 Jul-Aug;49(4):267-72. doi: 10.1080/00039896.1994.9937478.
PubMed 8031183Sulakvelidze I, Conway M, Evans S, Stetsko PI, Djuric V, Dolovich J. Clinical and nasal irrigation fluid findings in perennial allergic rhinitis. Am J Rhinol. 1997 Nov-Dec;11(6):435-41. doi: 10.2500/105065897780914965.
PubMed 9438056Keith PK, Conway M, Evans S, Wong DA, Jordana G, Pengelly D, Dolovich J. Nasal polyps: effects of seasonal allergen exposure. J Allergy Clin Immunol. 1994 Mar;93(3):567-74. doi: 10.1016/s0091-6749(94)70068-0.
PubMed 8151059Austin CE, Foreman JC. Acoustic rhinometry compared with posterior rhinomanometry in the measurement of histamine- and bradykinin-induced changes in nasal airway patency. Br J Clin Pharmacol. 1994 Jan;37(1):33-7. doi: 10.1111/j.1365-2125.1994.tb04235.x.
PubMed 8148216Juniper EF. Measuring health-related quality of life in rhinitis. J Allergy Clin Immunol. 1997 Feb;99(2):S742-9. doi: 10.1016/s0091-6749(97)90000-2.
PubMed 9042066Keith PK, Conway M, Dolovich J.Development and validation of a nasal-polyposis quality of life questionniare. Journal of Allergy and Clinical Immunology 1996;97:192 (Abstract)
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Cell Counts in Nasal Lavage: A Comparison of Pooled Versus Non-Pooled Nasal Lavage Samples
- ClinicalTrials.gov ID
- NCT00229190
- Acronym / sponsor ID
- 04-227
- Conditions
- Nasal Lavage Fluid, Eosinophils, Reproducibility of Results
- Keywords
- Nasal lavage fluid, Eosinophils, Reproducibility of results
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Firestone Institute for Respiratory Health
- Study start
- Sep 2004
- Study completion
- May 2005 (actual)
- First posted
- 29 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is male or female aged 18 years or older.
- Subject understands the research project and agrees to participate by signing an informed consent agreement.
- Subject is able to successfully complete nasal lavage training session.
Key exclusion criteria (13 listed)
- Subjects with severe nasal polyps which prevent collecting adequate nasal lavage sample.
- Subjects who have undergone surgery to treat their nasal polyps (nasal polypectomy) within one year prior to visit one
- Subjects who have a known fungal infection of the nose and/or paranasal sinuses, nasal candidiasis, acute or chronic infectious sinusitis of viral or bacterial nature.
- Subjects who have had an upper respiratory tract infection within four weeks prior to visit one.
- Subjects having cystic fibrosis, Young's syndrome, primary ciliary dyskinesia, known HIV infection or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal lavage | Procedure or surgery | – |
| Allergy skin testing | Procedure or surgery | – |
| Peak nasal inspiratory flow | Procedure or surgery | – |
| Acoustic rhinometry | Procedure or surgery | – |
| Nasal examination | Procedure or surgery | – |
| Quality of Life Questionnaire | Procedure or surgery | – |
| Physical examination | Procedure or surgery | – |
Primary outcome
Eosinophil per cent of cells recovered in lavage fluid
1 secondary outcome
Albumen concentration in lavage fluid
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2007.
- Background: PubMed 6354022Naclerio RM, Meier HL, Kagey-Sobotka A, Adkinson NF Jr, Meyers DA, Norman PS, Lichtenstein LM. Mediator release after nasal airway challenge with allergen. Am Rev Respir Dis. 1983 Oct;128(4):597-602. doi: 10.1164/arrd.1983.128.4.597.
- Background: PubMed 7508349Finotto S, Dolovich J, Denburg JA, Jordana M, Marshall JS. Functional heterogeneity of mast cells isolated from different microenvironments within nasal polyp tissue. Clin Exp Immunol. 1994 Feb;95(2):343-50. doi: 10.1111/j.1365-2249.1994.tb06535.x.
- Background: PubMed 2315937Koren HS, Hatch GE, Graham DE. Nasal lavage as a tool in assessing acute inflammation in response to inhaled pollutants. Toxicology. 1990 Jan-Feb;60(1-2):15-25. doi: 10.1016/0300-483x(90)90159-e.
- Background: PubMed 10383595Miadonna A, Milazzo N, Gibelli S, Salmaso C, Lorini M, Tedeschi A. Nasal response to a single antigen challenge in patients with allergic rhinitis - inflammatory cell recruitment persists up to 48 hours. Clin Exp Allergy. 1999 Jul;29(7):941-9. doi: 10.1046/j.1365-2222.1999.00609.x.
- Background: PubMed 7551384Noah TL, Henderson FW, Henry MM, Peden DB, Devlin RB. Nasal lavage cytokines in normal, allergic, and asthmatic school-age children. Am J Respir Crit Care Med. 1995 Oct;152(4 Pt 1):1290-6. doi: 10.1164/ajrccm.152.4.7551384.
- Background: PubMed 11944028Nikasinovic-Fournier L, Just J, Seta N, Callais F, Sahraoui F, Grimfeld A, Momas I. Nasal lavage as a tool for the assessment of upper-airway inflammation in adults and children. J Lab Clin Med. 2002 Mar;139(3):173-80. doi: 10.1067/mlc.2002.121661.
- Background: PubMed 11468003Belda J, Parameswaran K, Keith PK, Hargreave FE. Repeatability and validity of cell and fluid-phase measurements in nasal fluid: a comparison of two methods of nasal lavage. Clin Exp Allergy. 2001 Jul;31(7):1111-5. doi: 10.1046/j.1365-2222.2001.01133.x.
- Background: PubMed 2364306Greiff L, Pipkorn U, Alkner U, Persson CG. The 'nasal pool' device applies controlled concentrations of solutes on human nasal airway mucosa and samples its surface exudations/secretions. Clin Exp Allergy. 1990 May;20(3):253-9. doi: 10.1111/j.1365-2222.1990.tb02680.x.
- Background: PubMed 8031183Hauser R, Garcia-Closas M, Kelsey KT, Christiani DC. Variability of nasal lavage polymorphonuclear leukocyte counts in unexposed subjects: its potential utility for epidemiology. Arch Environ Health. 1994 Jul-Aug;49(4):267-72. doi: 10.1080/00039896.1994.9937478.
- Background: PubMed 9438056Sulakvelidze I, Conway M, Evans S, Stetsko PI, Djuric V, Dolovich J. Clinical and nasal irrigation fluid findings in perennial allergic rhinitis. Am J Rhinol. 1997 Nov-Dec;11(6):435-41. doi: 10.2500/105065897780914965.
- Background: PubMed 8151059Keith PK, Conway M, Evans S, Wong DA, Jordana G, Pengelly D, Dolovich J. Nasal polyps: effects of seasonal allergen exposure. J Allergy Clin Immunol. 1994 Mar;93(3):567-74. doi: 10.1016/s0091-6749(94)70068-0.
- Background: PubMed 8148216Austin CE, Foreman JC. Acoustic rhinometry compared with posterior rhinomanometry in the measurement of histamine- and bradykinin-induced changes in nasal airway patency. Br J Clin Pharmacol. 1994 Jan;37(1):33-7. doi: 10.1111/j.1365-2125.1994.tb04235.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Keith, MD MSc FRCPC principal investigator
Hamilton Health Sciences Corporation, McMaster Site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal lavage, Allergy skin testing and Peak nasal inspiratory flow in people with Nasal Lavage Fluid and Eosinophils, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eosinophil per cent of cells recovered in lavage fluid. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00229190, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2007.