COPDNCT00159354
Measurement of Smoking-Induced Neutrophil Activation
A study testing predisolone in people with COPD, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- predisolone
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2005to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- FEV1<70%
- FEV1/VC<70%,
- no other relevant medical or mental disorder, able to give informed consent
Who cannot join
- Female asymptomatic smokers
- ex-smokers
- other lung disorder
- relevant medical or mental illness
- recent (within 1 month) chest infection
- diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Smoking-Induced Neutrophil Activation as a Potential Biomarker of Response to Therapeutic Interventions in COPD: Proof of Concept Study
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.
Read the detailed description
Asymptomatic smokers will be recruited by advertisement in newspapers and from posters displayed in the local community.Patients 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 7:30am. 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 prednisolone/placebo, 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.
- Conditions
- COPD
- Being tested
- predisolone
- Keywords
- FDG-PET, pulmonary inflammation,, smoking,, COPD, steroid intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pneumonia, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
predisoloneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification of neutrophil activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Hazel A Jones, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159354
- Sponsor's protocol ID
- FDG-PETsmoking
- Status last verified
- Oct 2023
- First submitted
- 8 Sep 2005
- Last updated
- 4 Oct 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Smoking-Induced Neutrophil Activation as a Potential Biomarker of Response to Therapeutic Interventions in COPD: Proof of Concept Study
- ClinicalTrials.gov ID
- NCT00159354
- Acronym / sponsor ID
- FDG-PETsmoking
- Conditions
- COPD
- Keywords
- FDG-PET, pulmonary inflammation,, smoking,, COPD, steroid intervention
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 community.Patients 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 7:30am. 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 prednisolone/placebo, 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (6 listed)
- Female asymptomatic smokers
- ex-smokers
- other lung disorder
- relevant medical or mental illness
- recent (within 1 month) chest infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| predisolone | Drug | – |
Primary outcome
Modification of neutrophil activation
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazel A Jones, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing predisolone in people with COPD, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification of neutrophil activation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.