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

NCT01550679 | Completed DMC

• 2 other identifiers: CHSCRT114338GSK eTrack number CRT114338
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 6

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.

Conditions

COPD; Smoking; Other Diagnoses, Comorbidities, and Complications

Outcome Measures

Primary Outcomes (4)

• Inner consistency, repeatability, intelligibility, and applicability of MARKO questionnaire

  MARKO questionnaire will be tested for inner consistency, repeatability, intelligibility, applicability after the patient is diagnosed as having COPD and staged for severity of COPD by pulmologist. Patients will be tested twice using the same MARKO QoL questionnaire: first time at the recruitment at the primary health clinic and the second time at pulmologist office. It will be tested for it's potential to differentiate between patients with different stages of COPD.

  4 weeks after recruitment visit (2 yrs after start of recruitment)

• Discriminative power of MARKO questionnaire combined with screening lung function measurement for diagnosis of COPD

  Discriminative power of MARKO questionnaire combined with screening lung function measurement using COPD6 lung function screening apparatus will be assessed for different stages of COPD based on the assessment of the diagnosis and staging of COPD made by pulmologist according to Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines.

  4 weeks after recruitment visit (2 yrs after start of recruitment)

• The percentage of patients progressing from GOLD 0 stage to GOLD I stage or higher

  The percentage of patients progressing from GOLD 0 stage to GOLD I stage or higher will be assessed based on two evaluation by pulmologist: the first one 4 weeks after recruitment when diagnosis and staging of COPD will be made and the second one after 2 (3,5) years of follow up of patient in stages GOLD 0 and I. Patients will be characterized as GOLD 0 on the first visit if they are eligible for the study and have the lung function within the normal range or as GOLD I if they have FEV1/FVC \<0.7 and FEV1 \>80% of normal.

  After 2 years, 3 years, and 5 years of follow-up

• Discriminative power of MARKO questionnaire combined with screening lung function measurement for an early diagnosis of COPD

  Discriminative power of MARKO questionnaire combined with screening lung function measurement using COPD6 lung function screening device will be assessed for an early diagnosis of COPD based on the comparison of two groups of patients: patients progressing from GOLD 0 stage to GOLD I stage or higher after 2 (3, 5) years of follow-up based on the evaluation by pulmologist according to GOLD guidelines. Patients will be characterized as GOLD 0 if they have the lung function within the normal range or as GOLD I if they have FEV1/FVC \<0.7 and FEV1 \>80% of normal.

  After 2 years, 3 years, and 5 years of follow-up

Secondary Outcomes (5)

• Prevalence of concomitant disorders in this population

  4 weeks after recruitment visit (2 yrs after start of recruitment)

• Sensitivity of diagnostic parameters for early impairment in COPD

  4 weeks after recruitment visit (2 yrs after start of recruitment)

• Predictability of developed screening questionnaire (MARKO questionnaire), and markers of early impairment in COPD for the progression of COPD

  After 2 years, 3 years, and 5 years of follow-up

• Comparison of MARKO questionnaire with other diagnostic tools used for evaluation of patients

  After 2 years, 3 years, and 5 years of follow-up

• Prevalence of different stages of COPD (specifically GOLD stages 0 and I) in the population at risk for COPD and in general population

  4 weeks after recruitment visit (2 yrs after start of recruitment)

Study Arms (1)

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

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• Smokers or ex-smokers
• years of age
• at least 20 pack-years of smoking history

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital Srebrnjak: lead
• GlaxoSmithKline: collaborator
• University Hospital Rijeka: collaborator
• Clinical Hospital Center, Split: collaborator
• General Hospital Dubrovnik: collaborator
• Institute for Medical Research and Occupational Health, Zagreb: collaborator
• Osijek University Hospital: collaborator

Study Sites (6)

University Hospital Osijek

Osijek, Slavonsko-Baranjska, 31000, Croatia

Location

General Hospital Dubrovnik

Dubrovnik, 20000, Croatia

Location

University Hospital Rijeka

Rijeka, 51000, Croatia

Location

Clinical Hospital Center, Split

Split, 21000, Croatia

Location

Children's Hospital Srebrnjak

Zagreb, 10000, Croatia

Location

Institute for Medical Research and Occupational Health, Zagreb

Zagreb, 10000, Croatia

Location

Related Publications (2)

• 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.

  PMID: 28187733 DERIVED

• 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.

  PMID: 27542843 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Davor Plavec, MD, PhD

  Children's Hospital Srebrnjak

  PRINCIPAL INVESTIGATOR

• Žarko Vrbica, MD, MSc

  General Hospital Dubrovnik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist.Prof., MD, PhD

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 12, 2012
• Study Start: October 1, 2010
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

CR (6)