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AsthmaNCT00147069

Leukocyte Function in Asthma and COPD

An observational study of Asthma and COPD, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to examine the inflammatory mechanisms involved in the pathogenesis of inflammatory lung disease, in particular to compare the inflammatory profile seen in asthma and COPD. Read more about this study

Who is it for?
Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Asthma, COPD, Emphysema
How many people
60 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2004to Apr 2007
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Four groups of subjects were recruited: patients with COPD (cigarette smokers), diagnosed according to current standard criteria, patients with asthma (non-smokers), diagnosed according to current standard criteria, including a personal history of asthma, current smokers without airways obstruction (FEV1480% predicted) and non-smoking control subjects without lung disease

Who may be able to join

  • Asthmatic patients:
  • Age 21-79 years of both sexes (females will be taking adequate contraceptive measures).
  • Increase in FEV1 >15% and >200ml following beta2 agonist inhalation, either at the time of study or previously documented
  • COPD patients:
  • Stable patients with a post-salbutamol FEV1 30-70% predicted normal of >1L
  • Increase in FEV1 < 15% and < 200 ml following beta2 agonist inhalation, either at the time of study or previously documented
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  • Age 21-79 years of both sexes (females will be taking adequate contraceptive measures )
  • Smokers
  • No history of allergic or respiratory disease.
  • Normal Volunteers
  • Age 21-79 years of both sexes (females will be taking adequate contraceptive measures )
  • Non-smokers
  • Normal lung function
  • No upper respiratory tract infection within the last 4 weeks
  • No history of allergic or respiratory disease.
  • Healthy Smokers 1. Age 21-79 years of both sexes (females will be taking adequate contraceptive measures ) 2. Smokers 3. Normal lung function 4. No upper respiratory tract infection within the last 4 weeks
  • -

Who cannot join

  • Asthmatic patients with FEV1 less than 40% predicted value
  • Alcohol abuse
  • Any history or evidence of hepatic, cardiovascular or renal disease
  • Any history or evidence of neuropsychiatric disease
  • Drug abuse or any other condition associated with poor compliance
  • Pregnancy or breast feeding
Show all 10Show fewer
  • Patients are unable to provide written informed consent
  • COPD patients:
  • 1. Any other active lung diseases 2. Upper respiratory infection within the last 4 weeks 3. Pregnancy or breast feeding 4. Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study 5. Subjects unable to give informed consent
  • -

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Royal Brompton Hospital/NHLI Imperial College London

    London, SW3 6LY

Other trials in United Kingdom

About this study

Official title: Investigation Into Inflammatory Mechanisms in Airway Cells in Smokers and Non-smokers With Inflammatory Lung Disease.

The aim of this study is to examine the inflammatory mechanisms involved in the pathogenesis of inflammatory lung disease, in particular to compare the inflammatory profile seen in asthma and COPD. Evidence for inflammation in asthma and COPD is based on the finding of increased numbers of macrophages and neutrophils in the lungs and respiratory secretions of these patients. The inflammatory cells produce proteases, as well as, reactive oxidant species resulting in a protease/anti-protease imbalance which favours lung destruction. The aim is to examine the inflammatory mediators released by inflammatory cells (such as, macrophages and lymphocytes) in order to determine whether there are differences between non-smoking subjects, smoking subjects and patients with asthma or COPD. Monocytes are precursors of alveolar macrophages, and both monocytes and neutrophils are recruited to the lung from the blood via the action of specific chemoattractants. We have evidence that in inflammation there are higher levels of these chemoattractants. Therefore these cells might also demonstrate the same changes seen in alveolar macrophages from these patients.

We also aim to assess the role of the macrophage precursor (monocyte) and neutrophils in the blood. We will also assess lymphocyte/monocyte interaction. We will do this as the lymphocyte may be involved in the initial recruitment of inflammatory cells. We will also assess the role of cytokines involved with monocyte/macrophage/neutrophil migration in induced sputum as well as the role of induced sputum in the migration of monocytes and neutrophils into the lung. Our aim is to link the initial changes in blood to the changes causing disease in the lungs. We aim to examine cellular responses in four groups of subjects, namely (i) non-smoking controls, (ii) smokers without clinical evidence of COPD or asthma, (iii) smokers with COPD (iv) asthmatic patients.

Read the detailed description

Overall subjects will be characterised into one of four groups: normal non-smoking subjects, healthy smokers, patients with asthma and patients with COPD. Subjects will have had to fulfil inclusion and exclusion criteria, and give written consent.

Recruitment Methods. Volunteer subjects (healthy non-smokers and healthy smokers) will be recruited from within the National Heart and Lung Institute. Volunteers will be recruited via advertising using ethically approved advertisements. Asthmatic and COPD patients will be recruited from the outpatient clinic at The Royal Brompton Hospital. At the screening visit, the diagnosis of asthma or COPD will be confirmed from the clinical case notes. If the patient is a volunteer, they will undergo a full history and examination, spirometry. Each subject will attend on one study visit only. At the first visit a number of investigations will be undertaken including, spirometry with reversibility (400 microg ventolin via metered dose inhaler if initial spirometry shows an obstructive picture to exclude asthmatics), and sputum induction. In addition, 50ml of venous blood will be taken.

More specifically, the following interventions will be undertaken by each subject

  1. Medical History and Physical Examination A full medical history and physical examination (including height and weight) will be performed on the initial screening visit, in addition to that recorded in the clinical case notes.
  2. Respiratory Assessments Forced Expiratory Volume per second (FEVI) will be measured using a dry wedge spirometer (Vitalograph, Buckingham, UK) and expressed as a percent of predicted value. Subjects will be trained in the use of the apparatus before beginning the study. The baseline value at each visit will be measured after at least fifteen minutes of quiet rest, and will be taken as the highest of three readings made at one minute intervals. 400 microg ventolin administered via a metered dose inhaler will be given if initial spirometry shows an obstructive picture (FEV1 <80% predicted, FEV1 /FVC<70%) in order to distinguish between the presence of asthma or COPD.
  3. Sputum Induction Sputum induction will be performed in the Asthma Laboratory. The subject will inhale 3.5% saline at room temperature, nebulised via a De Vilbiss 99 Ultrasonic nebuliser set, at maximum output using a mouthpiece. After five minutes the subject will rinse his/her mouth thoroughly with water, and will be asked to cough deeply and expectorate sputum into a pot. Samples from this first five minute collection are discarded. This procedure will continue for a further ten minutes, and the resulting sample will be collected in a polypropylene pot. It is important to explain to the subject that the aim is to obtain sputum, and that saliva should be disposed of by spitting into a bowl which is later discarded. In the case of any chest discomfort or shortness of breath, the procedure is stopped and spirometry is repeated. If the FEV1 has fallen by 10% of the predicted value, the subject can rest until the FEV1 has returned to the baseline value or the procedure can be terminated. Sputum samples will be analysed for differential and absolute cell counts (eosinophils, neutrophils, macrophages, lymphocytes, and columnar epithelial cells). Sputum supernatants will be assayed for TNF-alpha, IL-8, interferon-gamma, and other cytokine levels. Immunohistochemistry will be performed on the induced sputum samples to identify the cellular localisation of factors involved with leukocyte function. Cytospin preparations will be made for differential cell counts and the soluble fraction will be used for cytokine assays.
  4. Venous Blood Sampling Fifty (50) millilitres of blood shall be venesected at the study visit. We will investigate factors involved in leukocyte function and chemotaxis. We will also assess cellular distributions of receptors thought to be important in regulation by using FACS analysis.
Keywords
sputum, macrophage, neutrophil
Medical subject headings
Asthma, Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00147069
Study groupRoleWhat they receive
ControlsNon-smoking control subjects without lung disease
AsthmaticsNon-smokers patients with asthma
Non-COPD smokersCurrent smokers without airways obstruction, FEV1 >80% predicted
COPD smokersPatients with COPD and cigarette smokers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Number of Inflammatory Cells Recovered in Sputum

    Sputum was induced via inhalation of hypertonic saline as previously described, and was processed for differential counts of inflammatory cells.

    Measured: 1 year

  2. Number of Matrix Metalloproteases (MMPs) MMP1

    MMPs determined using paired antibody quantitative ELISAs

    Measured: 1 year

  3. Number of Matrix Metalloproteases (MMPs) MMP3

    MMPs determined using paired antibody quantitative ELISAs

    Measured: 1 year

  4. Number of Matrix Metalloproteases (MMPs) MMP8

    MMPs determined using paired antibody quantitative ELISAs

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2005 (estimated)
  2. Study startApr 2004
  3. Primary completionApr 2007
  4. Study completionApr 2007

Resources

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
Case-control
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00147069
Sponsor's protocol ID
04-059
Status last verified
Dec 2019
First submitted
6 Sep 2005
Last updated
5 Dec 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Culpitt SV, Rogers DF, Traves SL, Barnes PJ, Donnelly LE. Sputum matrix metalloproteases: comparison between chronic obstructive pulmonary disease and asthma. Respir Med. 2005 Jun;99(6):703-10. doi: 10.1016/j.rmed.2004.10.022. Epub 2004 Dec 13.

    PubMed 15878486

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and COPD, 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 10 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: finished, as of the sponsor's last update on 5 Dec 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?

Yes. Results are posted in the registry (first posted 5 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Total Number of Inflammatory Cells Recovered in Sputum (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00147069, which also lists 1 linked publication.

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 5 Dec 2019.

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