Genomic/ Proteomic/ Metabonomic Profiling in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00655694

Last Updated: 2019-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sputum, blood, urine, exhaled breath, lung function

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Non-smoking volunteer aged 40 -75 years (age matched to COPD patients)
* Normal spirometry (FEV1/FVC ratio \>70% and FEV1\>80% predicted)
* 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

* 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

Exclusion Criteria

* 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
* 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

* 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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sergei A Kharitonov, MD PhD

Role: PRINCIPAL_INVESTIGATOR

National Heart and Lung Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Heart and Lung Institute

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

05/Q0410/97

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.