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Early Detection of COPD Patients in GOLD 0 (Smokers) Population

NCT ID: NCT01550679

Last Updated: 2020-12-29

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

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2020-04-30

Brief Summary

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Even though the main risk factor for the development of chronic obstructive pulmonary disease (COPD) is smoking only in less than one third of the smokers the clinically manifest COPD will develop. The disease progressive nature with high disability and mortality especially in the final stages makes it plausible to detect the disease as early as possible thus allowing for the early intervention. Major intervention trials in COPD, "Towards a Revolution in COPD Health" (TORCH), "Investigating New Standards for Prophylaxis in Reducing Exacerbations" (INSPIRE), and "Understanding Potential Long-term Impacts on Function with Tiotropium" (UPLIFT) have recently shown that the beneficial impact of intervention was larger in patients being treated in earlier stages of the disease development. Till now the only tool for an early diagnosis and early intervention that could be used on the global scale was spirometry even though symptoms and deprivation of quality of life (QoL) precedes clinically relevant spirometric changes. So there is a need for a new simple tool that would allow detection of patients in a very early stage of COPD.

So the aim of this study is the development of diagnostic tools for an early detection of COPD, even before the significant change in spirometry.

Detailed Description

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Conditions

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COPD Smoking Other Diagnoses, Comorbidities, and Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Smokers or ex-smokers

Smokers or ex-smokers 40-65 years of age with a smoking history of at least 20 pack-years with no diagnosis of COPD or asthma

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Smokers or ex-smokers
* 40-65 years of age
* at least 20 pack-years of smoking history

Exclusion Criteria

* any clinically relevant chronic disorder with a significant influence on QoL
* immuno-suppressive treatment
* significant acute respiratory disorder during last 4 weeks
* hospitalization during last 3 months
* acute myocardial information, cerebro-vascular infarction or transient ishemic attack during last 6 months
* asthma
* unable to perform the study protocol (diagnostic workout)
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University Hospital Rijeka

OTHER

Sponsor Role collaborator

Clinical Hospital Center, Split

OTHER

Sponsor Role collaborator

General Hospital Dubrovnik

OTHER

Sponsor Role collaborator

Institute for Medical Research and Occupational Health, Zagreb

UNKNOWN

Sponsor Role collaborator

Osijek University Hospital

OTHER

Sponsor Role collaborator

Children's Hospital Srebrnjak

OTHER

Sponsor Role lead

Responsible Party

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Davor Plavec

Assist.Prof., MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Davor Plavec, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Srebrnjak

Žarko Vrbica, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

General Hospital Dubrovnik

Locations

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University Hospital Osijek

Osijek, Slavonsko-Baranjska, Croatia

Site Status

General Hospital Dubrovnik

Dubrovnik, , Croatia

Site Status

University Hospital Rijeka

Rijeka, , Croatia

Site Status

Clinical Hospital Center, Split

Split, , Croatia

Site Status

Children's Hospital Srebrnjak

Zagreb, , Croatia

Site Status

Institute for Medical Research and Occupational Health, Zagreb

Zagreb, , Croatia

Site Status

Countries

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Croatia

References

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Vrbica Z, Labor M, Gudelj I, Labor S, Juric I, Plavec D; MARKO study group. Early detection of COPD patients in GOLD 0 population: an observational non-interventional cohort study - MARKO study. BMC Pulm Med. 2017 Feb 10;17(1):36. doi: 10.1186/s12890-017-0378-6.

Reference Type DERIVED
PMID: 28187733 (View on PubMed)

Labor M, Vrbica Z, Gudelj I, Labor S, Plavec D. Diagnostic accuracy of a pocket screening spirometer in diagnosing chronic obstructive pulmonary disease in general practice: a cross sectional validation study using tertiary care as a reference. BMC Fam Pract. 2016 Aug 19;17(1):112. doi: 10.1186/s12875-016-0518-8.

Reference Type DERIVED
PMID: 27542843 (View on PubMed)

Other Identifiers

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GSK eTrack number CRT114338

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CHSCRT114338

Identifier Type: -

Identifier Source: org_study_id