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

April 4, 2008
April 9, 2008
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March 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00655954 on ClinicalTrials.gov Archive Site
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Osteoprotegerin (OPG) in Induced Chronic Obstructive Pulmonary Disease (COPD) Sputum
Osteoprotegerin (OPG) in Induced Sputum as a Novel Biomarker for COPD
  • 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
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Observational
Time Perspective: Prospective
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Pulmonary Disease, Chronic Obstructive
Procedure: sputum, blood, condensate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
35 Years and older
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Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00655954
05-Q0407-91
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Imperial College London
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Principal Investigator: Sergei A Kharitonov, MD PhD National Heart and Lung Institute
Imperial College London
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP