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

NCT00655954 | Completed

• 1 other identifier: 05-Q0407-91
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; asthma; smokers; healthy volunteers; bronchiectasis; cystic fibrosis

Outcome Measures

Primary Outcomes (1)

• Sputum OPG

  Sputum OPG as assessed by ELISA at baseline

  1 hour

Study Arms (3)

Healthy volunteers non smoker

18 volunteers

Procedure: Induced sputum

Healthy volunteers smoker

15 volunteers

Procedure: Induced sputum

Chronic Obstructive Pulmonary Disease COPD

39 volunteers

Procedure: Induced sputum

Interventions

Induced sputum PROCEDURE

Used Ultrasonic nebuliser

Chronic Obstructive Pulmonary Disease COPD; Healthy volunteers non smoker; Healthy volunteers smoker

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were recruited from the outpatient department of Royal Brompton Hospital and local general practices. Patients with COPD were diagnosed using the GOLD (Global Initiative for Obstructive Lung Disease) criteria. 25 Patients with COPD who had an exacerbation during the last 2 months prior to the visit were excluded. Patients with asthma were diagnosed using the GINA (Global Initiative for Asthma) guidelines for asthma. 26 Patients with any other lung diseases were excluded from the study. This study was reviewed and approved by the Hounslow and Hillingdon Research Ethics Committee. Written informed consent was obtained from all subjects.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

National Heart and Lung Institute

London, SW3 6LY, United Kingdom

Location

Related 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.

  PMID: 21127170 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Bronchiectasis; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Sergei A Kharitonov, MD PhD

  National Heart and Lung Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)