AsthmaNCT00180726
Molecular Mechanism of Asthma
A study testing Blood sampling, Endoscopic Bronchoscopy, Spirometry in people with Asthma, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The aim of this study is to investigate the mechanisms whereby lung function is decreased in asthma and sensitivity to treatment. The hypothesis is that in diseases such as asthma, inflammatory cells (leukocytes) including eosinophils, macrophages and lymphocytes migrate to the lung and release either more or… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Blood sampling, Endoscopic Bronchoscopy, Spirometry
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2003to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 17Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Airway Disease, NHLI, Imperial College
London, SW3 6LY
About this study
Official title: Regulation of Inflammatory Mediators in Asthma
The aim of this study is to investigate the mechanisms whereby lung function is decreased in asthma and sensitivity to treatment. The hypothesis is that in diseases such as asthma, inflammatory cells (leukocytes) including eosinophils, macrophages and lymphocytes migrate to the lung and release either more or different types of inflammatory mediators and/or receptors compared to subjects without asthma, which are corticoid sensitive or insensitive. 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Blood sampling, Endoscopic Bronchoscopy, Spirometry
- Keywords
- asthma, inflammatory, corticosteroid
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling, Endoscopic Bronchoscopy, SpirometryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression evaluated using mRNA
Secondary outcomes (1)
corticosteroid sensitivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2003
- Study completionJul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Investigators
- Ian M Adcock, PhD, Principal investigator, NHLI, Imperial College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180726
- Sponsor's protocol ID
- NHLI-MB-1
- Status last verified
- May 2019
- First submitted
- 13 Sep 2005
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Inflammatory Mediators in Asthma
- ClinicalTrials.gov ID
- NCT00180726
- Acronym / sponsor ID
- NHLI-MB-1
- Conditions
- Asthma
- Keywords
- asthma, inflammatory, corticosteroid
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Jul 2007 (estimated)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the mechanisms whereby lung function is decreased in asthma and sensitivity to treatment. The hypothesis is that in diseases such as asthma, inflammatory cells (leukocytes) including eosinophils, macrophages and lymphocytes migrate to the lung and release either more or different types of inflammatory mediators and/or receptors compared to subjects without asthma, which are corticoid sensitive or insensitive. 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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling, Endoscopic Bronchoscopy, Spirometry | Procedure or surgery | – |
Primary outcome
gene expression evaluated using mRNA
1 secondary outcome
corticosteroid sensitivity
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian M Adcock, PhD principal investigator
NHLI, Imperial College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, Endoscopic Bronchoscopy, Spirometry in people with Asthma, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gene expression evaluated using mRNA. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.