Nasal Lavage Study: Comparing Single Versus Multi Sample Lavages

NCT00229190 | Completed

• 2 other identifiers: 04-2272003/11
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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 (e.g. runny nose, congestion, sneezing, post nasal drip), and in individuals without nasal symptoms.

Conditions

Nasal Lavage Fluid; Eosinophils; Reproducibility of Results

Keywords

Nasal lavage fluid; Eosinophils; Reproducibility of results

Outcome Measures

Primary Outcomes (1)

• Eosinophil per cent of cells recovered in lavage fluid

Secondary Outcomes (1)

• Albumen concentration in lavage fluid

Interventions

Nasal lavage PROCEDURE

Allergy skin testing PROCEDURE

Peak nasal inspiratory flow PROCEDURE

Acoustic rhinometry PROCEDURE

Nasal examination PROCEDURE

Quality of Life Questionnaire PROCEDURE

Physical examination PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Firestone Institute for Respiratory Health: collaborator

Study Sites (1)

Hamilton Health Sciences Corporation, McMaster Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (14)

• 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.

  PMID: 6354022 BACKGROUND

• Finotto 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.

  PMID: 7508349 BACKGROUND

• Koren 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.

  PMID: 2315937 BACKGROUND

• Miadonna 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.

  PMID: 10383595 BACKGROUND

• Noah 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.

  PMID: 7551384 BACKGROUND

• Nikasinovic-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.

  PMID: 11944028 BACKGROUND

• Belda 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.

  PMID: 11468003 BACKGROUND

• Greiff 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.

  PMID: 2364306 BACKGROUND

• Hauser 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.

  PMID: 8031183 BACKGROUND

• Sulakvelidze 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.

  PMID: 9438056 BACKGROUND

• Keith 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.

  PMID: 8151059 BACKGROUND

• Austin 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.

  PMID: 8148216 BACKGROUND

• Juniper 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.

  PMID: 9042066 BACKGROUND

• Keith 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)

  BACKGROUND

MeSH Terms

Interventions

Nasal Lavage; Skin Tests; Restraint, Physical

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Immunologic Techniques; Behavior Control; Therapeutics; Immobilization

Study Officials

• Paul Keith, MD MSc FRCPC

  Hamilton Health Sciences Corporation, McMaster Site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 29, 2005
• Study Start: September 1, 2004
• Study Completion: May 1, 2005
• Last Updated: April 24, 2007

Record last verified: 2007-04

Locations

CA (1)