Genomic/ Proteomic/ Metabonomic Profiling in Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsored by:	Imperial College London
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00655694

Purpose

Chronic obstructive pulmonary disease (COPD) is a chronic disease characterized by progressive airflow obstruction, chronic cough and dyspnoea in advanced stages. 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.

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.

Condition	Intervention
Pulmonary Disease, Chronic Obstructive	Procedure: sputum, blood, urine, exhaled breath, lung function

Study Type:	Observational
Study Design:	Cohort, Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma COPD (Chronic Obstructive Pulmonary Disease) Urine and Urination

U.S. FDA Resources

Further study details as provided by Imperial College London:

Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Inclusion Criteria - Healthy non-smokers
- 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%
- 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
Inclusion Criteria - healthy smokers
- 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
Inclusion Criteria - asthmatics
- 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

Exclusion Criteria:

Exclusion Criteria - Healthy non-smokers
- 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
- 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
Exclusion Criteria - healthy smokers
- 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
Exclusion Criteria - asthmatics
- 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655694

Locations

United Kingdom
National Heart and Lung Institute
London, United Kingdom, SW3 6LY

Sponsors and Collaborators

Imperial College London

Investigators

Principal Investigator:

Sergei A Kharitonov, MD PhD

National Heart and Lung Institute

More Information

No publications provided

Study ID Numbers:	05/Q0410/97
Study First Received:	April 4, 2008
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00655694 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

COPD
smokers
healthy volunteers

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders

Asthma
Chronic Disease
Healthy
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

Lung Diseases
Respiration Disorders
Chronic Disease
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 09, 2009