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

NCT ID: NCT00655954

Last Updated: 2019-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-03-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy volunteers non smoker

18 volunteers

Induced sputum

Intervention Type PROCEDURE

Used Ultrasonic nebuliser

Healthy volunteers smoker

15 volunteers

Induced sputum

Intervention Type PROCEDURE

Used Ultrasonic nebuliser

Chronic Obstructive Pulmonary Disease COPD

39 volunteers

Induced sputum

Intervention Type PROCEDURE

Used Ultrasonic nebuliser

Interventions

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Induced sputum

Used Ultrasonic nebuliser

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergei A Kharitonov, MD PhD

Role: PRINCIPAL_INVESTIGATOR

National Heart and Lung Institute

Locations

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National Heart and Lung Institute

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 21127170 (View on PubMed)

Other Identifiers

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05-Q0407-91

Identifier Type: -

Identifier Source: org_study_id

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