Clinical trial NCT01550679: Early Detection of COPD Patients in GOLD 0 (Smokers) Population
Official title: Early Detection of COPD Patients in GOLD 0 (Smokers) Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Smoking
Other Diagnoses, Comorbidities, and Complications
Lead sponsor: Children's Hospital Srebrnjak
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: University Hospital Rijeka
name: Clinical Hospital Center, Split
name: General Hospital Dubrovnik
name: Institute for Medical Research and Occupational Health, Zagreb
name: Osijek University Hospital
First posted: 2012-03-12
Enrollment: 450
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Inner consistency, repeatability, intelligibility, and applicability of MARKO questionnaire
timeFrame: 4 weeks after recruitment visit (2 yrs after start of recruitment)
measure: Discriminative power of MARKO questionnaire combined with screening lung function measurement for diagnosis of COPD
timeFrame: 4 weeks after recruitment visit (2 yrs after start of recruitment)
measure: The percentage of patients progressing from GOLD 0 stage to GOLD I stage or higher
timeFrame: After 2 years, 3 years, and 5 years of follow-up
measure: Discriminative power of MARKO questionnaire combined with screening lung function measurement for an early diagnosis of COPD
timeFrame: After 2 years, 3 years, and 5 years of follow-up
Secondary outcomes:
measure: Prevalence of concomitant disorders in this population
timeFrame: 4 weeks after recruitment visit (2 yrs after start of recruitment)
measure: Sensitivity of diagnostic parameters for early impairment in COPD
timeFrame: 4 weeks after recruitment visit (2 yrs after start of recruitment)
measure: Predictability of developed screening questionnaire (MARKO questionnaire), and markers of early impairment in COPD for the progression of COPD
timeFrame: After 2 years, 3 years, and 5 years of follow-up
measure: Comparison of MARKO questionnaire with other diagnostic tools used for evaluation of patients
timeFrame: After 2 years, 3 years, and 5 years of follow-up
measure: Prevalence of different stages of COPD (specifically GOLD stages 0 and I) in the population at risk for COPD and in general population
timeFrame: 4 weeks after recruitment visit (2 yrs after start of recruitment)
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: University Hospital Osijek
state: Slavonsko-Baranjska
city: Dubrovnik
country: Croatia
facility: General Hospital Dubrovnik
city: Rijeka
country: Croatia
facility: University Hospital Rijeka
city: Split
country: Croatia
facility: Clinical Hospital Center, Split
city: Zagreb
country: Croatia
facility: Children's Hospital Srebrnjak
city: Zagreb
country: Croatia
facility: Institute for Medical Research and Occupational Health, Zagreb
Study officials:
affiliation: Children's Hospital Srebrnjak
name: Davor Plavec, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital Dubrovnik
name: Žarko Vrbica, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.