Leukocyte Function in Asthma and COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00147069
First received: September 6, 2005
Last updated: March 25, 2014
Last verified: September 2005
  Purpose

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
Asthma
COPD
Emphysema
Chronic Bronchitis

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Enrollment: 90
Study Start Date: April 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00147069

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

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00147069     History of Changes
Other Study ID Numbers: 04-059
Study First Received: September 6, 2005
Last Updated: March 25, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
sputum
macrophage
neutrophil

Additional relevant MeSH terms:
Asthma
Bronchitis
Bronchitis, Chronic
Emphysema
Pulmonary Emphysema
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Pathologic Processes

ClinicalTrials.gov processed this record on July 10, 2014