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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655954
• Other study ID #: 05-Q0407-91
• Status: Completed
• Start date: January 2008
• Est. completion date: March 2010

Study information

• Verified date: July 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Induced sputum
Used Ultrasonic nebuliser

Locations

Country	Name	City	State
United Kingdom	National Heart and Lung Institute	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

To M, Ito K, Ausin PM, Kharitonov SA, Barnes PJ. Osteoprotegerin in sputum is a potential biomarker in COPD. Chest. 2011 Jul;140(1):76-83. doi: 10.1378/chest.10-1608. Epub 2010 Dec 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum OPG	Sputum OPG as assessed by ELISA at baseline	1 hour