Chronic Obstructive Airway DiseaseNCT00180765
Regulation of the Release of Inflammatory Mediators From Blood Leukocytes
An observational study of Chronic Obstructive Airway Disease and Healthy Volunteers, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Chronic obstructive pulmonary disease (COPD for short) involves inflammation inside the air passages of the lungs. This inflammation might be partly responsible for the shortness of breath, cough and susceptibility to chest infections that form part of COPD. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Airway Disease, Healthy Volunteers
- What is being tested?
- Up to 100ml blood will be taken by venupuncture.
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2001to Feb 2008
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy non-smoking subjects: All normal volunteers will meet the following criteria:
- Age 21-70 years.
- No history of respiratory or allergic disease.
- Normal baseline spirometry as predicted for age, sex and height.
- Non-smokers.
- No history of upper respiratory tract infection in the preceding six weeks.
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- Not taking regular medication
- COPD subjects: COPD is diagnosed according to American Thoracic Society, European Respiratory Society and British Thoracic Society guidelines by the doctors in Professor Barnes' COPD clinic. All COPD volunteers will meet the following criteria:
- Age between 40-75 years.
- A smoking history of at least 20 pack years. ( 1 pack year = 20 cigarettes per day for 1 year)
- FEV1:FVC ratio of <0.7, post-bronchodilator FEV1 of <85% predicted, reversibility with inhaled b2-agonist of <15% of predicted FEV1: all three criteria are required.
- Current smokers or smokers who had ceased smoking for at least 6 months.
- No history of exacerbation, oral steroid or antibiotic use within the preceding 6 weeks.
- Normal serum a-1 antitrypsin level.
- No history of other respiratory or allergic disease.
- No evidence of atopy on skin prick testing to common aeroallergens (grass pollen, cat hair, house dust mite or Aspergillus fumigatus
- These tests will have already been performed as part of routine assessment in Professor Barnes' COPD clinic and we will not need to repeat them for this study.
- Healthy Smokers: All healthy smoking volunteers in trials will meet the following criteria:
- Age 21-70 years.
- Smoking history of at least 10 pack years (1 pack year = 20 cigarettes per day for 1 year).
- No history of respiratory or allergic disease.
- Normal baseline spirometry as predicted for age, sex and height.
- No history of upper respiratory tract infection in the preceding six weeks.
- Not taking regular medication.
Who cannot join
- Subjects will not 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 COPD in the COPD group.
- Pregnant women or mothers who are breastfeeding.
- Subjects who are unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Heart & Lung Institute, Imperial College
Chelsea, London, SW3 6LY
About this study
Official title: Regulation of the Release of Inflammatory Mediators From Blood Leukocytes: A Comparison of Healthy Subjects, Healthy Smokers and Patients With COPD.
Chronic obstructive pulmonary disease (COPD for short) involves inflammation inside the air passages of the lungs. This inflammation might be partly responsible for the shortness of breath, cough and susceptibility to chest infections that form part of COPD. Inflammation is caused, in part, by white blood cells that are attracted from the blood into the air passages. Once inside the air passages, the white blood cells may change (or 'differentiate') and release substances that produce inflammation and attract more white cells. The hypothesis is that the lifespan of these cells may also be prolonged such that they produce more inflammatory mediators and in turn perpetuate inflammation. The cycle of inflammation may damage the lungs, so we want to see what mediators are released by white blood cells and determine if we can inhibit this effect with existing and new drugs. We would also like to see the effect of these drugs on the life-span and function of white blood cells. We will compare the behaviour and characteristics of white cells with those from healthy smokers and healthy non-smokers to find out if there is anything different about cells from COPD patients.
Read the detailed description
The aim of this study is to investigate the mechanisms that regulate the survival of blood leukocytes as well as the synthesis and release of inflammatory mediators from cells from normal individuals and subjects with COPD. The hypothesis is that in COPD the life-span of leukocytes, such as the neutrophil, is enhanced and this may contribute to inflammation, a prominent characteristic of this disease, by secreting and releasing inflammatory mediators. We also suggest that differences may exist in the sensitivity of the various leukocytes to different therapies.
Leukocytes will be purified from the peripheral venous blood of patients with COPD as well as healthy individuals. We will then investigate the effects of novel and existing therapeutic agents on leukocyte survival and inflammatory mediator synthesis and release. We will also examine the regulation and release of enzymes known to damage lung tissue. Further studies will be carried out to elucidate the signal transduction pathways that lead to the activation, altered longevity and function of leukocytes. In other experiments ribonucleic acids or RNA may be extracted form leukocytes to investigate which genes are involved. The primary objective is to identify the mechanisms that enhance leukocyte longevity and inflammatory mediator and/or enzyme synthesis and release with a view to identifying novel targets for drug therapy.
- Being tested
- Up to 100ml blood will be taken by venupuncture.
- Keywords
- Leukocytes, Eosinophils, Neutrophils, Chronic Obstructive Airway Disease, Apoptosis, Signal Transduction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Up to 100ml blood will be taken by venupuncture.Procedure or surgery
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 startOct 2001 (estimated)
- Primary completionFeb 2007 (estimated)
- Study completionFeb 2008 (estimated)
Why it stopped: No funding for the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Airway DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Asthma UK
- Responsible party
- Sponsor
- Investigators
- Peter J Barnes, DSc, Principal investigator, National Heart & Lung Institute, Imperial College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180765
- Sponsor's protocol ID
- 01-215
- Status last verified
- Jul 2019
- First submitted
- 13 Sep 2005
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of the Release of Inflammatory Mediators From Blood Leukocytes: A Comparison of Healthy Subjects, Healthy Smokers and Patients With COPD.
- ClinicalTrials.gov ID
- NCT00180765
- Acronym / sponsor ID
- 01-215
- Keywords
- Leukocytes, Eosinophils, Neutrophils, Chronic Obstructive Airway Disease, Apoptosis, Signal Transduction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding for the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Asthma UK
- Study start
- Oct 2001 (estimated)
- Primary completion
- Feb 2007 (estimated)
- Study completion
- Feb 2008 (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.
Chronic obstructive pulmonary disease (COPD for short) involves inflammation inside the air passages of the lungs. This inflammation might be partly responsible for the shortness of breath, cough and susceptibility to chest infections that form part of COPD. Inflammation is caused, in part, by white blood cells that are attracted from the blood into the air passages. Once inside the air passages, the white blood cells may change (or 'differentiate') and release substances that produce inflammation and attract more white cells. The hypothesis is that the lifespan of these cells may also be prolonged such that they produce more inflammatory mediators and in turn perpetuate inflammation. The cycle of inflammation may damage the lungs, so we want to see what mediators are released by white blood cells and determine if we can inhibit this effect with existing and new drugs. We would also like to see the effect of these drugs on the life-span and function of white blood cells. We will compare the behaviour and characteristics of white cells with those from healthy smokers and healthy non-smokers to find out if there is anything different about cells from COPD patients.
Detailed description
The aim of this study is to investigate the mechanisms that regulate the survival of blood leukocytes as well as the synthesis and release of inflammatory mediators from cells from normal individuals and subjects with COPD. The hypothesis is that in COPD the life-span of leukocytes, such as the neutrophil, is enhanced and this may contribute to inflammation, a prominent characteristic of this disease, by secreting and releasing inflammatory mediators. We also suggest that differences may exist in the sensitivity of the various leukocytes to different therapies.
Leukocytes will be purified from the peripheral venous blood of patients with COPD as well as healthy individuals. We will then investigate the effects of novel and existing therapeutic agents on leukocyte survival and inflammatory mediator synthesis and release. We will also examine the regulation and release of enzymes known to damage lung tissue. Further studies will be carried out to elucidate the signal transduction pathways that lead to the activation, altered longevity and function of leukocytes. In other experiments ribonucleic acids or RNA may be extracted form leukocytes to investigate which genes are involved. The primary objective is to identify the mechanisms that enhance leukocyte longevity and inflammatory mediator and/or enzyme synthesis and release with a view to identifying novel targets for drug therapy.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age 21-70 years.
- No history of respiratory or allergic disease.
- Normal baseline spirometry as predicted for age, sex and height.
- Non-smokers.
- No history of upper respiratory tract infection in the preceding six weeks.
Key exclusion criteria (4 listed)
- Subjects will not 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 COPD in the COPD group.
- Pregnant women or mothers who are breastfeeding.
- Subjects who are unable to give informed consent.
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 |
|---|---|---|
| Up to 100ml blood will be taken by venupuncture. | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 10 Jul 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.
Peter J Barnes, DSc principal investigator
National Heart & Lung Institute, Imperial College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Airway Disease and Healthy Volunteers, 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 24 inclusion and 4 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 10 Jul 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.
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 10 Jul 2019.