NCT00159354

Brief Summary

Neutrophil involvement in the development of COPD by smokers is well recognised. However not all smokers develop overt lung disease. We have previously shown that uptake of FDG is related to neutrophil activity and can be measured by PET and that uptake is greater in COPD patients than normal subjects. We have also shown that FDG-PET shows inflammatory changes in asymptomatic smokers after cigarette smoking. We plan to investigate the attenuation of this inflammation by steroid tablets and whether FDG PET can demonstrate this. We also wish to establish if similar changes are demonstrated after smoking by COPD patients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

First QC Date

September 8, 2005

Last Update Submit

October 3, 2023

Conditions

COPD

Keywords

FDG-PETpulmonary inflammation,smoking,COPDsteroid intervention

Outcome Measures

Primary Outcomes (1)

  • Modification of neutrophil activation

Interventions

predisoloneDRUG

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male smokers \>10 pack.year history,
  • FEV1\>80% predicted,
  • no relevant medical or mental disorder, able to give informed consent and
  • Patients with COPD,
  • \>20 pack.year history,
  • no other active lung disease,
  • FEV1\<70%
  • FEV1/VC\<70%,
  • no other relevant medical or mental disorder, able to give informed consent

You may not qualify if:

  • Female asymptomatic smokers
  • ex-smokers
  • other lung disorder
  • relevant medical or mental illness
  • recent (within 1 month) chest infection
  • diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Campus

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructivePneumoniaSmoking

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsBehavior

Study Officials

  • Hazel A Jones, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

June 1, 2005

Study Completion

December 1, 2006

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations

GB(1)