NCT00147082

Brief Summary

The aim of this study is to investigate the mechanisms whereby leukocytes are recruited to the lung in chronic obstructive pulmonary disease (COPD) and cause tissue destruction. The hypothesis is that in COPD more leukocytes enter the lung and it is these cells that are responsible for the degradation of lung tissue. We, the researchers at Imperial College London, will isolate leukocytes from the blood of patients with COPD, healthy smokers and normal subjects and measure the movement of the leukocytes to chemoattractants. We will examine further, which cell surface receptors are responsible for this trafficking of cells. Furthermore, the differentiation of these cells in vitro will be compared with cells from healthy smokers and normal subjects. Specifically, the expression of enzymes that are responsible for tissue destruction and the cell surface receptors on these cells will be investigated. The objective is to identify the mechanisms whereby leukocytes from COPD patients behave differently to cells from healthy smokers and normal subjects with a view to identify novel targets for drug therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
12.7 years until next milestone

Results Posted

Study results publicly available

December 5, 2019

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

3.8 years

First QC Date

September 6, 2005

Results QC Date

November 6, 2019

Last Update Submit

December 4, 2019

Conditions

Keywords

chemokinechemokine receptorneutrophillymphocytemonocyte

Outcome Measures

Primary Outcomes (3)

  • Effective Concentration (EC 50) of GRO Alpha

    Migration response of PBMC to Chemokine EC 50 represents the concentration of a drug that is required for 50% inhibition in vitro

    2 hours

  • Effective Concentration of IL-8

    Migration response of PBMC to Chemokine EC 50 represents the concentration of a drug that is required for 50% inhibition in vitro

    2 hours

  • Effective Concentration of MCP-1

    Migration response of PBMC to Chemokine

    2 hours

Study Arms (3)

COPD

Patients with COPD - no intervention

Smokers without COPD

Smokers without COPD - no intervention

Non-smokers

Non-smokers with no history of respiratory disease - no intervention

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had taken inhaled or oral steroids or who had suffered an exacerbation of their airway disease in the previous 6 weeks were excluded.

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. 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 packs of cigarettes per day for 1 year)
  • Forced expiratory volume at 1 second : Forced vital capacity (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.
  • 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 alpha-1 antitrypsin level.
  • No history of other respiratory or allergic disease.
  • +8 more criteria

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton Hospital/NHLI Imperial College London

London, SW3 6LY, United Kingdom

Location

Related Publications (1)

  • Traves SL, Smith SJ, Barnes PJ, Donnelly LE. Specific CXC but not CC chemokines cause elevated monocyte migration in COPD: a role for CXCR2. J Leukoc Biol. 2004 Aug;76(2):441-50. doi: 10.1189/jlb.1003495. Epub 2004 May 20.

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysemaBronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Results Point of Contact

Title
Professor Louise Donnelly
Organization
Imperial College London

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
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 7, 2005

Study Start

February 1, 2001

Primary Completion

December 1, 2004

Study Completion

April 1, 2007

Last Updated

December 5, 2019

Results First Posted

December 5, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations