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Leukocyte Function in Asthma and COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00147069
Recruitment Status : Completed
First Posted : September 7, 2005
Results First Posted : December 5, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief 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. 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.


Condition or disease
Asthma COPD Emphysema Chronic Bronchitis

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Investigation Into Inflammatory Mechanisms in Airway Cells in Smokers and Non-smokers With Inflammatory Lung Disease.
Actual Study Start Date : April 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
Controls
Non-smoking control subjects without lung disease
Asthmatics
Non-smokers patients with asthma
Non-COPD smokers
Current smokers without airways obstruction, FEV1 >80% predicted
COPD smokers
Patients with COPD and cigarette smokers



Primary Outcome Measures :
  1. Total Number of Inflammatory Cells Recovered in Sputum [ Time Frame: 1 year ]
    Sputum was induced via inhalation of hypertonic saline as previously described, and was processed for differential counts of inflammatory cells.

  2. Number of Matrix Metalloproteases (MMPs) MMP1 [ Time Frame: 1 year ]
    MMPs determined using paired antibody quantitative ELISAs

  3. Number of Matrix Metalloproteases (MMPs) MMP3 [ Time Frame: 1 year ]
    MMPs determined using paired antibody quantitative ELISAs

  4. Number of Matrix Metalloproteases (MMPs) MMP8 [ Time Frame: 1 year ]
    MMPs determined using paired antibody quantitative ELISAs


Biospecimen Retention:   Samples Without DNA
sputum


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

Asthmatic patients:

  1. Age 21-79 years of both sexes (females will be taking adequate contraceptive measures).
  2. Increase in FEV1 >15% and >200ml following beta2 agonist inhalation, either at the time of study or previously documented

COPD patients:

  1. Stable patients with a post-salbutamol FEV1 30-70% predicted normal of >1L
  2. Increase in FEV1 < 15% and < 200 ml following beta2 agonist inhalation, either at the time of study or previously documented
  3. Age 21-79 years of both sexes (females will be taking adequate contraceptive measures )
  4. Smokers
  5. No history of allergic or respiratory disease.

Normal Volunteers

  1. Age 21-79 years of both sexes (females will be taking adequate contraceptive measures )
  2. Non-smokers
  3. Normal lung function
  4. No upper respiratory tract infection within the last 4 weeks
  5. 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

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Exclusion Criteria:

  1. Asthmatic patients with FEV1 less than 40% predicted value
  2. Alcohol abuse
  3. Any history or evidence of hepatic, cardiovascular or renal disease
  4. Any history or evidence of neuropsychiatric disease
  5. Drug abuse or any other condition associated with poor compliance
  6. Pregnancy or breast feeding
  7. 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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147069


Locations
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United Kingdom
Royal Brompton Hospital/NHLI Imperial College London
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Louise E Donnelly, PhD Imperial College London

Publications of Results:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00147069    
Other Study ID Numbers: 04-059
First Posted: September 7, 2005    Key Record Dates
Results First Posted: December 5, 2019
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
sputum
macrophage
neutrophil
Additional relevant MeSH terms:
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Asthma
Bronchitis
Bronchitis, Chronic
Emphysema
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Infections