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Completed

NCT Number: NCT00655954

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Induced sputum

Procedure

Used Ultrasonic nebuliser

Primary outcomes

  1. Sputum OPG

    Time frame: 1 hour

    Sputum OPG as assessed by ELISA at baseline

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Osteoprotegerin (OPG) in Induced Sputum as a Novel Biomarker for COPD

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 10, 2008
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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