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

8. juli 2019 oppdatert av: Imperial College London

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.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
      • London, Storbritannia, SW3 6LY
        • National Heart and Lung Institute

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

35 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Imperial College London

Etterforskere

  • Hovedetterforsker: Sergei A Kharitonov, MD PhD, National Heart and Lung Institute

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. januar 2005

Primær fullføring (Forventet)

1. september 2007

Studiet fullført (Forventet)

1. september 2007

Datoer for studieregistrering

Først innsendt

4. april 2008

Først innsendt som oppfylte QC-kriteriene

9. april 2008

Først lagt ut (Anslag)

10. april 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juli 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juli 2019

Sist bekreftet

1. juli 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 05/Q0410/97

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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