Regulation of the Release of Inflammatory Mediators From Blood Leukocytes

NCT00180765 | Withdrawn

• 1 other identifier: 01-215
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Obstructive Airway Disease; Healthy Volunteers

Keywords

Leukocytes; Eosinophils; Neutrophils; Chronic Obstructive Airway Disease; Apoptosis; Signal Transduction

Interventions

Up to 100ml blood will be taken by venupuncture. PROCEDURE

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• Asthma UK: collaborator

Study Sites (1)

National Heart & Lung Institute, Imperial College

Chelsea, London, SW3 6LY, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter J Barnes, DSc

  National Heart & Lung Institute, Imperial College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: October 1, 2001
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2008
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

GB (1)