Osteoprotegerin (OPG) in Induced Chronic Obstructive Pulmonary Disease (COPD) Sputum
9. juli 2019 oppdatert av: Imperial College London
Osteoprotegerin (OPG) in Induced Sputum as a Novel Biomarker for COPD
Evaluation of OPG level as disease markers has also been reported.
It has been showed that patients with coronary artery disease had higher serum OPG levels than healthy volunteers.
Moreover, serum OPG levels correlate with the number of stenotic coronary arteries
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Osteoprotegerin (OPG) is a secreted glycoprotein containing 401 amino acids.
It is a member of the tumour necrosis factor (TNF) receptor superfamily.
It was firstly discovered as a protein regulating bone metabolism, inhibiting osteoclastogenesis, consequently, inhibiting bone resorption OPG is detected in lung using Northern blot analysis.
It is likely that OPG would contribute to the pathogenesis of COPD and could be an effective disease marker of the disease
Studietype
Observasjonsmessig
Registrering (Faktiske)
72
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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London, Storbritannia, SW3 6LY
- National Heart and Lung Institute
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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
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Participants were recruited from the outpatient department of Royal Brompton Hospital and local general practices.
Patients with COPD were diagnosed using the GOLD (Global Initiative for Obstructive Lung Disease) criteria.
25 Patients with COPD who had an exacerbation during the last 2 months prior to the visit were excluded.
Patients with asthma were diagnosed using the GINA (Global Initiative for Asthma) guidelines for asthma.
26 Patients with any other lung diseases were excluded from the study.
This study was reviewed and approved by the Hounslow and Hillingdon Research Ethics Committee.
Written informed consent was obtained from all subjects.
Beskrivelse
Inclusion Criteria:
Healthy non-smokers
- Age <35 years (younger group)
- Aged matched to COPD patients (older group)
- Normal spirometry
- Subjects are able to give informed consent
Healthy smokers
- Age <35 years (younger group)
- Aged matched to COPD patients (older group)
- Normal spirometry
- Subjects are able to give informed consent Stable COPD patients: Stage I-IV according to the GOLD guidelines (3), (9)
- Current and/or ex-smokers with no less than 10 pack-year smoking history
- The subjects are able to give informed consent COPD patients with acute exacerbation: Stage I-IV according to the GOLD guidelines (3), (9)
- Exacerbation of COPD defined as "an event in the natural course of the disease characterised by a change in the patient's baseline dyspnoea, cough and/or sputum beyond day to day variability sufficient to warrant a change in management" (9)
- Current and/or ex-smokers with no less than 10 pack-year smoking history
- The subjects are able to give informed consent Asthma patients
- Patients diagnosed with asthma
- The subjects are able to give informed consent Bronchiectasis patients
- Patients with CT-confirmed bronchiectasis
- The subjects are able to give informed consent Cystic fibrosis patients
- Patients diagnosed with cystic fibrosis
- The subjects are able to give informed consent
Exclusion Criteria:
Healthy non-smokers and smokers
- Upper respiratory infection 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 Stable COPD patients
- Patients who have had an exacerbation which required treatment with oral steroids during the last 2 months prior to the visit
- Upper respiratory infection 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 COPD patients with acute exacerbation
- 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 Asthma
- Upper respiratory infection 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.
Bronchiectasis and cystic fibrosis
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Healthy volunteers non smoker
18 volunteers
|
Used Ultrasonic nebuliser
|
|
Healthy volunteers smoker
15 volunteers
|
Used Ultrasonic nebuliser
|
|
Chronic Obstructive Pulmonary Disease COPD
39 volunteers
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Used Ultrasonic nebuliser
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sputum OPG
Tidsramme: 1 hour
|
Sputum OPG as assessed by ELISA at baseline
|
1 hour
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Sergei A Kharitonov, MD PhD, National Heart and Lung Institute
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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 (Faktiske)
1. januar 2008
Primær fullføring (Faktiske)
1. mars 2010
Studiet fullført (Faktiske)
1. mars 2010
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
9. juli 2019
Sist bekreftet
1. juli 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 05-Q0407-91
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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