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

This study has been completed.
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00655954
First received: April 4, 2008
Last updated: April 9, 2008
Last verified: April 2008
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013