Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159354
Status:
TERMINATED
Last Update Posted:
2023-10-04
First Post:
2005-09-08
Brief Title:
Measurement of Smoking-Induced Neutrophil Activation
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Evaluation of Smoking-Induced Neutrophil Activation as a Potential Biomarker of Response to Therapeutic Interventions in COPD Proof of Concept Study
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Asymptomatic smokers will be recruited by advertisement in newspapers and from posters displayed in the local communityPatients will be recruited from Hammersmith Hospital NHS Trust and local GP surgeries where we shall display posters We shall also directly ask patients whom we think may be suitable This could be at a respiratory clinic after they attend the lung function department for routine tests and at GP and practice nurse appointments After discussing the research outline with the subjects either in person or by phone we shall give them the information sheet and ask them to attend for a screening visit This will be a chance for them to ask more questions and for us to obtain informed consent We will then carry out a brief medical examination and routine lung function tests Providing they fulfil the inclusion criteria we shall then organise the subsequent visits for 2 scans if they are patients with COPD or 3 if they are asymptomatic smokers All participants will undergo chest X-ray to exclude other lung disease unless they have had one in the past year They must abstain for smoking for at least 12 hours prior to visit and fast for 4 hours prior to scan On the first day of attendance they will have a brief medical to assess whether they are clinically stable and have spirometry and CO monitored to confirm abstinence For the scan visits the asymptomatic smokers will take the placebo or prednisolone the previous evening at 10pm and again the next morning with a light breakfast by 730am On 2 scan days they will smoke 2 cigarettes 4h later 60 minutes prior to scan The PET scan takes about 90 minutes and includes blood sampling throughout They must be able to lie still in the scanner We will aim to complete the scans at 1-2 week intervals whilst clinically stable
The COPD patients will not take prednisoloneplacebo but will either smoke 2 real or dummy cigarettes prior to scan This protocol is similar to others used previously which have proved acceptable to COPD patients and healthy smokers
The COPD patients will not take prednisoloneplacebo but will either smoke 2 real or dummy cigarettes prior to scan This protocol is similar to others used previously which have proved acceptable to COPD patients and healthy smokers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None