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Montelukast and Nasal Epithelial Cell Inflammatory Responses in Asthma and Rhinitis

NCT ID: NCT01230437

Last Updated: 2010-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Hypothesis

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.

Conditions

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Asthma Allergic Rhinitis

Keywords

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montelukast asthma allergic rhinitis nasal epithelial cells inflammatory mediators

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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asthmatic patients taking montelukast

asthma with or without rhinitis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Nasal corticosteroid therapy
Minimum Eligible Age

10 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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University of Aberdeen

Principal Investigators

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Garry M Walsh, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Locations

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University of Aberdeen

Aberdeen, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Garry M Walsh, PhD

Role: CONTACT

Phone: +44 (0) 1224 552786

Email: [email protected]

Graham Devereux, MD, PhD

Role: CONTACT

Phone: +44 (0) 1224 558196

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 18483420 (View on PubMed)

Other Identifiers

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MT091 RGD 1265

Identifier Type: OTHER

Identifier Source: secondary_id

MSD-36765-IISP

Identifier Type: -

Identifier Source: org_study_id