- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01230437
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
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Aberdeen, United Kingdom, AB25 2ZD
- University of Aberdeen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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asthmatic patients taking montelukast
asthma with or without rhinitis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of montelukast on nasal epithelial cell secretion in vitro.
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of 1-week montelukast withdrawal on clinical scores and pro-inflammatory cytokine output by nasal epithelial cells
Time Frame: 12 months
|
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12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Garry M Walsh, PhD, University of Aberdeen
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Otorhinolaryngologic Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Asthma
- Rhinitis
- Rhinitis, Allergic
Other Study ID Numbers
- MSD-36765-IISP
- MT091 RGD 1265 (Other Identifier: University of Aberdeen)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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