- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00180726
Molecular Mechanism of Asthma
Regulation of Inflammatory Mediators in Asthma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We aim to investigate these separate cell types in the blood of subjects with asthma and identify which genes are more highly expressed when compared to cells obtained from patients without asthma. We will investigate corticosteroid sensitivity on gene expression in asthma (corticoid naive to corticosteroid resistant asthma). We will also investigate the lung cells (macrophages) from these subjects to identify whether the same or different genes are expressed in these cells.
We will isolate different leukocyte populations from the blood and extract ribonucleic acid (RNA) from these samples. The type and quantity of RNA in these samples is a reflection of the specific genes expressed in these cells. Gene expression is also evaluated by ELISA.This RNA will be sent to Gene Logic in the USA and this company will test these samples to identify which genes have been expressed using Gene Arrays. This technique will examine the expression of all 33,000 human genes in each sample to examine activation of interacting pathways rather than individual genes at a time. Samples will be analysed in the USA and preliminary data shows that there are no problems involving sample transportation or degradation.
Similar experiments will be performed using cells (macrophages) obtained following bronchoalveolar lavage of these subjects. We would aim to examine the responses of cells from two groups of subjects, namely (i) non-asthmatics controls and (ii) asthmatic subjects. The isolated cells will either be immediately solubilized in solutions to purify RNA or we will then use these isolated cells in vitro and following stimulation investigate whether different genes are expressed or at a differential rate in the disease state. We will examine both cells derived from peripheral blood and cells (macrophages) obtained from bronchoalveolar lavage with the aim to determine whether differences attributable to disease can be identified in both circulating cells and those at the site of disease.
This is a preliminary study to determine the profile of inflammatory mediator expression from leukocytes and as such power calculations to determine the number of subjects is not appropriate.
The objective of the study is to identify which genes are specifically expressed in important cells in patients with asthma with a view to identify novel targets for drug therapy.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom, SW3 6LY
- Airway Disease, NHLI, Imperial College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Asthmatic Patients
- Stable asthmatics on beta-2 agonist alone not using more than 4 puffs per day
- Atopic as defined by positive skin prick tests to at least 2 common aeroallergens
- PC20 methacholine of < 4 mg /ml
- Increase in FEV1 > 15% following beta-2 agonist inhalation, either at the time of study or previously documented
- Age 21-55 years of both sexes (females will be taking adequate contraceptive measures)
- Non-smokers
- Normal chest x-ray (CXR) and electrocardiogram (ECG) within the last 6 months.
Healthy Non-Asthmatic Subjects
All normal volunteers will meet the following criteria:
- Age 21-70 years of both sexes (females will be taking adequate contraceptive measures)
- No history of respiratory or allergic disease e.g. PC20 methacholine of > 64mg/ml and negative skin prick tests
- Non-atopic with negative skin prick tests to common aeroallergens
- Normal baseline spirometry as predicted for age, sex and height.
- Non-smokers
- Not taking regular medication
- No upper respiratory tract infection within the last 6 weeks
Exclusion Criteria:
Subjects will not be included in this study if they meet any of the following exclusion criteria:
- Clinically significant findings in the medical history or on physical examination other than those of asthma in the asthma group.
- Lung function FEV1 <30%
- Pregnant women or mothers who are breastfeeding.
- Patients who smoke
- Upper respiratory infection within the last 4 weeks
- Allergy to local anaesthetic
- Subjects who are unable to give informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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gene expression evaluated using mRNA
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Secondary Outcome Measures
Outcome Measure |
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corticosteroid sensitivity
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ian M Adcock, PhD, NHLI, Imperial College
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHLI-MB-1
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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