Pulmonary Disease, Chronic ObstructiveNCT00655694
Genomic/ Proteomic/ Metabonomic Profiling in Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Pulmonary Disease, Chronic Obstructive, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic disease characterized by progressive airflow obstruction, chronic cough and dyspnoea in advanced stages. We hope to develop a better understanding of lung disease. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- sputum, blood, urine, exhaled breath, lung function
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2005to Sep 2007
- Phase
- Observational
- 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 35 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Non-smoking volunteer aged 40 -75 years (age matched to COPD patients)
- Normal spirometry (FEV1/FVC ratio >70% and FEV1>80% predicted)
- Subjects are able to give informed consent Inclusion Criteria-COPD patients (stage 2-3 according to the GOLD guidelines)
- Current and/or ex-smokers with no less than 10 pack-year smoking history aged 40-75 years
- 30% FEV1 < 80% of predicted (the upper value is a postbronchodilator value)
- FEV1/FVC < 70%
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- Stable COPD (no chest infection requiring antibiotics and/ or oral steroids in the past 2 months)
- Long-acting beta2-agonists and long-acting antimuscarinic bronchodilators need to be stopped at least 8 hours before the study visit
- The subjects are able to give informed consent
- Current smokers aged 40 -75 years (age matched to COPD patients)
- Normal spirometry (normal FEV1/FVC ratio >70% and FEV1>80% predicted)
- Subjects are able to give informed consent
- Non-smoking asthma patients aged 40 -75 years (age matched to COPD patients)
- Normal spirometry (normal FEV1/FVC ratio >70% and FEV1>80% predicted)
- Subjects are able to give informed consent
Who cannot join
- Chest infection that required treatment with antibiotics within the last 4 weeks
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study Exclusion Criteria-COPD patients
- Bronchodilator reversibility > 12%
- Chest infection that required treatment with antibiotics within the last 4 weeks
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- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
- Patients with significant co-morbidities including any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study as judged by the investigator
- Any other respiratory disease, which is considered by the investigator to be clinically significant
- Chest infection that required treatment with antibiotics within the last 4 weeks
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
- Chest infection that required treatment with antibiotics within the last 4 weeks
- Patients with significant co-morbidities as judged by the investigator
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non Interventional Study to Asses the Utility of Genomic/ Proteomic/ Metabonomic Profiling Approaches to the Classification and Pathological Basis of Inflammatory Lung Disease in Smokers, and Ex-smokers vs. Non-smokers and Asthmatics
Chronic obstructive pulmonary disease (COPD) is a chronic disease characterized by progressive airflow obstruction, chronic cough and dyspnoea in advanced stages.
We hope to develop a better understanding of lung disease. Information from these studies will only be used for research purposes, to help develop safer and more effective treatments for asthma and COPD.
Read the detailed description
Techniques such as genomics, proteomics and metabonomics, Technologies that aim to identify and quantify the dynamic set of all small molecules and metabolites present in an organism or a biological sample, offer the prospect of efficiently distinguishing individuals with particular diseases. The advantages of proteomics and metabonomics is that it can be carried out on a standard preparation of serum, plasma or urine, circumventing the need for specialist preparation of cellular mRNA required for genomics This methodology is based on mass spectrometry (MS), gas chromatography-mass spectrometry (GC-MS), and nuclear magnetic resonance (NMR) to analyze metabolites. High-performance liquid chromatography (HPLC) may also be applied. Several peak alignment algorithms have been developed to match the chromatograms before applying pattern recognition. Based on the pattern recognition, several potential biomarkers may be found and further identified by MS.. Finally, a number of potential biomarkers will be identified for distinguishing asthma and COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- sputum, blood, urine, exhaled breath, lung function
- Keywords
- COPD, smokers, healthy volunteers
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sputum, blood, urine, exhaled breath, lung functionProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startJan 2005 (estimated)
- Primary completionSep 2007 (estimated)
- Study completionSep 2007 (estimated)
Why it stopped: Lead Researcher left the Department
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergei A Kharitonov, MD PhD, Principal investigator, National Heart and Lung Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655694
- Sponsor's protocol ID
- 05/Q0410/97
- Status last verified
- Jul 2019
- First submitted
- 4 Apr 2008
- Last updated
- 10 Jul 2019
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non Interventional Study to Asses the Utility of Genomic/ Proteomic/ Metabonomic Profiling Approaches to the Classification and Pathological Basis of Inflammatory Lung Disease in Smokers, and Ex-smokers vs. Non-smokers and Asthmatics
- ClinicalTrials.gov ID
- NCT00655694
- Acronym / sponsor ID
- 05/Q0410/97
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, smokers, healthy volunteers
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lead Researcher left the Department
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2005 (estimated)
- Primary completion
- Sep 2007 (estimated)
- Study completion
- Sep 2007 (estimated)
- First posted
- 10 Apr 2008 (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.
Chronic obstructive pulmonary disease (COPD) is a chronic disease characterized by progressive airflow obstruction, chronic cough and dyspnoea in advanced stages.
We hope to develop a better understanding of lung disease. Information from these studies will only be used for research purposes, to help develop safer and more effective treatments for asthma and COPD.
Detailed description
Techniques such as genomics, proteomics and metabonomics, Technologies that aim to identify and quantify the dynamic set of all small molecules and metabolites present in an organism or a biological sample, offer the prospect of efficiently distinguishing individuals with particular diseases. The advantages of proteomics and metabonomics is that it can be carried out on a standard preparation of serum, plasma or urine, circumventing the need for specialist preparation of cellular mRNA required for genomics This methodology is based on mass spectrometry (MS), gas chromatography-mass spectrometry (GC-MS), and nuclear magnetic resonance (NMR) to analyze metabolites. High-performance liquid chromatography (HPLC) may also be applied. Several peak alignment algorithms have been developed to match the chromatograms before applying pattern recognition. Based on the pattern recognition, several potential biomarkers may be found and further identified by MS.. Finally, a number of potential biomarkers will be identified for distinguishing asthma and COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
Key exclusion criteria (17 listed)
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 |
|---|---|---|
| sputum, blood, urine, exhaled breath, lung function | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Sergei A Kharitonov, MD PhD principal investigator
National Heart and Lung Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, 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 15 inclusion and 17 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: withdrawn, as of the sponsor's last update on 10 Jul 2019. 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 withdrawn before enrolling participants, so there are no results.
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.
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 10 Jul 2019.