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Osteoprotegerin (OPG) in Induced Chronic Obstructive Pulmonary Disease (COPD) Sputum

This study has been completed.

Sponsored by: Imperial College London
Information provided by: Imperial College London
ClinicalTrials.gov Identifier: NCT00655954
  Purpose
  • 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
  • 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
  • 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

Condition Intervention
Pulmonary Disease, Chronic Obstructive
Procedure: sputum, blood, condensate

Genetics Home Reference related topics:   cystic fibrosis   

MedlinePlus related topics:   COPD (Chronic Obstructive Pulmonary Disease)   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Prospective
Official Title:   Osteoprotegerin (OPG) in Induced Sputum as a Novel Biomarker for COPD

Further study details as provided by Imperial College London:

Study Completion Date:   March 2008
Primary Completion Date:   March 2008 (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:

  • 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655954

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    
Principal Investigator:     Sergei A Kharitonov, MD PhD     National Heart and Lung Institute    
  More Information


Study ID Numbers:   05-Q0407-91
First Received:   April 4, 2008
Last Updated:   April 9, 2008
ClinicalTrials.gov Identifier:   NCT00655954
Health Authority:   United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
COPD  
asthma  
smokers  
healthy volunteers
bronchiectasis
cystic fibrosis

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis
Bronchiectasis
Lung Diseases
Asthma
Chronic Disease
Healthy
Cystic fibrosis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 10, 2008




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