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

Children's Hospital Srebrnjak

Status: Completed

Conditions: Other Diagnoses, Comorbidities, and Complications; COPD; Smoking

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01550679

CHSCRT114338

GSK eTrack number CRT114338 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

450 participants in 1 patient group

Smokers or ex-smokers

Description:

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