Montelukast and Nasal Epithelial Cell Inflammatory Responses in Asthma and Rhinitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01230437|
Recruitment Status : Unknown
Verified October 2010 by University of Aberdeen.
Recruitment status was: Not yet recruiting
First Posted : October 29, 2010
Last Update Posted : October 29, 2010
|Condition or disease|
|Asthma Allergic Rhinitis|
The inflammatory secretory profile of nasal airway epithelial cells (NEC) cultured from asthmatics with concomitant allergic rhinitis (AR) will differ from that of NEC from patients with asthma alone. Treatment (in vitro and in vivo) with montelukast may have differential modulating effects in these two patient groups.
For the primary objective of this proposal we will use nasal AEC from asthmatics with or without concomitant AR as to ascertain differences in pro-inflammatory cytokine and chemokine production between these two groups and determine whether in vitro treatment with montelukast has a differential modulating effect on NEC secretion. In the secondary pilot study any modulating effects by montelukast on AEC secretion in vitro will be correlated with any in vivo response to montelukast withdrawal. This sub study will provide pilot data indicating whether in vivo response to montelukast can be predicted from in vitro effects on NEC.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||The Effect of Montelukast on Inflammatory Responses of Nasal Epithelial Cells Cultured From Patients With Asthma, With and Without Concomitant Allergic Rhinitis|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
asthmatic patients taking montelukast
asthma with or without rhinitis
- Effect of montelukast on nasal epithelial cell secretion in vitro. [ Time Frame: 12 months ]
- 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.
- Effect of 1-week montelukast withdrawal on clinical scores and pro-inflammatory cytokine output by nasal epithelial cells [ Time Frame: 12 months ]
- The secondary outcome of the study will be to examine the effect of withdrawal montelukast for 1-week on clinical scores and pro-inflammatory cytokine/ chemokine secretion by cultured NEC in montelukast-responsive patients with asthma (20 subjects) and asthma/AR (20 subjects).
- The clinical scores and NEC secretory responses in these patients following montelukast withdrawal will be compared with the responses generated in the primary study i.e., while taking montelukast.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230437
|Contact: Garry M Walsh, PhD||+44 (0) 1224 firstname.lastname@example.org|
|Contact: Graham Devereux, MD, PhD||+44 (0) 1224 email@example.com|
|University of Aberdeen||Not yet recruiting|
|Aberdeen, United Kingdom, AB25 2ZD|
|Principal Investigator:||Garry M Walsh, PhD||University of Aberdeen|