- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00655954
Osteoprotegerin (OPG) in Induced Chronic Obstructive Pulmonary Disease (COPD) Sputum
9 juli 2019 uppdaterad 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Observationell
Inskrivning (Faktisk)
72
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
London, Storbritannien, SW3 6LY
- National Heart and Lung Institute
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
35 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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
|
Used Ultrasonic nebuliser
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Sputum OPG
Tidsram: 1 hour
|
Sputum OPG as assessed by ELISA at baseline
|
1 hour
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Sergei A Kharitonov, MD PhD, National Heart and Lung Institute
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2008
Primärt slutförande (Faktisk)
1 mars 2010
Avslutad studie (Faktisk)
1 mars 2010
Studieregistreringsdatum
Först inskickad
4 april 2008
Först inskickad som uppfyllde QC-kriterierna
9 april 2008
Första postat (Uppskatta)
10 april 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 juli 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 juli 2019
Senast verifierad
1 juli 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 05-Q0407-91
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Induced sputum
-
University Medical Center GroningenRekrytering
-
University of Alabama at BirminghamAvslutadStroke | Övre extremitetspares | CVA (Cerebrovascular Accident)Förenta staterna
-
University of MiamiUniversity of FloridaAvslutadCystisk fibros | PediatrikFörenta staterna
-
US Department of Veterans AffairsAvslutad
-
Imperial College LondonChelsea and Westminster NHS Foundation Trust; Royal Brompton & Harefield... och andra samarbetspartnersRekryteringCovid-19 | SARS-CoV-2 | ARDS, människa | Immunsystemets störningStorbritannien
-
Ohio State UniversityVirginia Polytechnic Institute and State University; Nationwide Children...Avslutad
-
Istanbul UniversityOkänd
-
Imperial College LondonAstraZenecaIndragen
-
Fundació Institut de Recerca de l'Hospital de la...Spanish Clinical Research Network - SCReNAvslutad
-
University Hospital, MontpellierAktiv, inte rekryterande