Macrophage Phagocytosis in COPD

NCT00298389 | Completed Results

• 1 other identifier: 05/Q0404/111
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic obstructive pulmonary disease (COPD) that have frequent chest infections are the patients most likely to become worse over time. Why these people are more susceptible to chest infections is not known. One reason might be that the white cells in their lungs called macrophages do not work properly. Normally, these cells remove all the debris inhaled into the lung. This can also include bacteria. In patients with COPD, these macrophages are not able to remove these particles. The research question addresses why this happens

Conditions

Chronic Obstructive Pulmonary Disease; Emphysema; Chronic Bronchitis

Keywords

macrophage; phagocytosis; exacerbation

Outcome Measures

Primary Outcomes (2)

• Phagocytosis of H. Influenzae Concentration

  Measurement of phagocytosis in vitro, Phagocytosis of H. influenzae concentration

  1 hour

• Phagocytosis of S. Pneumoniae Concentration

  Measurement of phagocytosis in vitro, Phagocytosis of S. pneumoniae concentration

  1 hour

Study Arms (3)

Non smokers

Non smokers included no history of respiratory or allergic disease, normal baseline spirometry

Smokers

Smoking history of at least 10 pack years

COPD

Patients with stable COPD

Eligibility Criteria

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

Study Population

Healthy subjects, smokers without COPD and COPD patients

You may qualify if:

• Healthy non-smoking subjects:
• All normal volunteers will meet the following criteria:
• Age 21-75 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 35-75 years. A smoking history of at least 10 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 beta2-agonist of \<15% of predicted FEV1: all three criteria are required.

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

Study Sites (1)

Imperial College London

London, SW3 6LY, United Kingdom

Location

Related Publications (1)

• Taylor AE, Finney-Hayward TK, Quint JK, Thomas CM, Tudhope SJ, Wedzicha JA, Barnes PJ, Donnelly LE. Defective macrophage phagocytosis of bacteria in COPD. Eur Respir J. 2010 May;35(5):1039-47. doi: 10.1183/09031936.00036709. Epub 2009 Nov 6.

  PMID: 19897561 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Professor Louise Donnelly
• Organization: Imperial College London

l.donnelly@imperial.ac.uk

+442075947895

Study Officials

• Louise E Donnelly, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: March 1, 2006
• First Posted: March 2, 2006
• Study Start: October 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 3, 2019
• Results First Posted: November 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)