Montelukast and Nasal Epithelial Cell Inflammatory Responses in Asthma and Rhinitis
The Effect of Montelukast on Inflammatory Responses of Nasal Epithelial Cells Cultured From Patients With Asthma, With and Without Concomitant Allergic Rhinitis
2 other identifiers
observational
40
1 country
1
Brief Summary
The airways of the lung are lined by specialised cells called airway epithelial cells. As well as being at the interface between the lungs and the air we breathe; airway epithelial cell (AEC) function is altered in people with respiratory diseases such as asthma. AEC secrete many mediators that contribute to asthma symptoms and these also contribute to asthmatic inflammation in the lungs. The study of such cells is difficult because of their location deep in the lungs. Nasal airway epithelial cells provide a useful and easily accessible model of model of lower airway cells. This study will examine whether the asthma medication Singulair (montelukast) can inhibit the inflammatory secretions of nasal AEC of asthmatic patents who also have allergic rhinitis compared with patients who have asthma alone. We will also examine if montelukast has differential modulating effects in these two patient groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2011
Shorter than P25 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2010
CompletedFirst Posted
Study publicly available on registry
October 29, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedOctober 29, 2010
October 1, 2010
11 months
October 27, 2010
October 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of montelukast on nasal epithelial cell secretion in vitro.
* Nasal AEC will be cultured from 20 patients with asthma and 20 patients with asthma and concomitant allergic rhinitis. * Unstimulated, TNFα (a surrogate for viral infection, a well known trigger of exacerbations) or allergen stimulated secretion of IL-6, IL-10, INFgamma TGFbeta, GM-CSF, eotaxin 1 \& 2, RANTES and IL-8 by NEC will be measured. The in vitro inhibitory effects of a concentration range (10-6M to 10-10M) of montelukast will be assessed.
12 months
Secondary Outcomes (1)
Effect of 1-week montelukast withdrawal on clinical scores and pro-inflammatory cytokine output by nasal epithelial cells
12 months
Study Arms (1)
asthmatic patients taking montelukast
asthma with or without rhinitis
Eligibility Criteria
For the primary study the investigators will identify 40 patients (aged 10-60) with with stable physician confirmed mild/moderate asthma (Steps 1-4 of BTS/SIGN guidelines \[3\]) with \<10 pack-year smoking histories. Twenty of the subjects will have asthma and concomitant allergic rhinitis (asthma/AR) and 20 will have asthma alone.
You may qualify if:
- stable physician confirmed mild/moderate asthma (Steps 1-4 of BTS/SIGN guidelines \<10 pack-year smoking histories Currently taking montelukast with a documented clinical history of benefit
You may not qualify if:
- Nasal corticosteroid therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aberdeenlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
University of Aberdeen
Aberdeen, AB25 2ZD, United Kingdom
Related Publications (1)
McDougall CM, Blaylock MG, Douglas JG, Brooker RJ, Helms PJ, Walsh GM. Nasal epithelial cells as surrogates for bronchial epithelial cells in airway inflammation studies. Am J Respir Cell Mol Biol. 2008 Nov;39(5):560-8. doi: 10.1165/rcmb.2007-0325OC. Epub 2008 May 15.
PMID: 18483420BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Garry M Walsh, PhD
University of Aberdeen
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 27, 2010
First Posted
October 29, 2010
Study Start
January 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
October 29, 2010
Record last verified: 2010-10