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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Children's Hospital Srebrnjak
Sponsor:
Collaborators:
GlaxoSmithKline
University Hospital Rijeka
Clinical Hospital Center, Split
General Hospital Dubrovnik
Institute for Medical Research and Occupational Health, Zagreb
Information provided by (Responsible Party):
Davor Plavec, Children's Hospital Srebrnjak
ClinicalTrials.gov Identifier:
NCT01550679
First received: February 28, 2012
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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.


Condition
COPD
Smoking
Other Diagnoses, Comorbidities, and Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of COPD Patients in GOLD 0 (Smokers) Population

Resource links provided by NLM:


Further study details as provided by Children's Hospital Srebrnjak:

Primary Outcome Measures:
  • Inner consistency, repeatability, intelligibility, and applicability of MARKO questionnaire [ Time Frame: 4 weeks after recruitment visit (2 yrs after start of recruitment) ] [ Designated as safety issue: No ]
    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.

  • Discriminative power of MARKO questionnaire combined with screening lung function measurement for diagnosis of COPD [ Time Frame: 4 weeks after recruitment visit (2 yrs after start of recruitment) ] [ Designated as safety issue: No ]
    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.

  • The percentage of patients progressing from GOLD 0 stage to GOLD I stage or higher [ Time Frame: After 2 years, 3 years, and 5 years of follow-up ] [ Designated as safety issue: No ]
    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.

  • Discriminative power of MARKO questionnaire combined with screening lung function measurement for an early diagnosis of COPD [ Time Frame: After 2 years, 3 years, and 5 years of follow-up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Prevalence of concomitant disorders in this population [ Time Frame: 4 weeks after recruitment visit (2 yrs after start of recruitment) ] [ Designated as safety issue: No ]
  • Sensitivity of diagnostic parameters for early impairment in COPD [ Time Frame: 4 weeks after recruitment visit (2 yrs after start of recruitment) ] [ Designated as safety issue: No ]
    Diagnostic parameters will be assessed after the finish of recruitment for their sensitivity for an early impairment in COPD. The sensitivity will be assessed based on their discriminative power between COPD stages 0 and I.

  • Predictability of developed screening questionnaire (MARKO questionnaire), and markers of early impairment in COPD for the progression of COPD [ Time Frame: After 2 years, 3 years, and 5 years of follow-up ] [ Designated as safety issue: No ]
  • Comparison of MARKO questionnaire with other diagnostic tools used for evaluation of patients [ Time Frame: After 2 years, 3 years, and 5 years of follow-up ] [ Designated as safety issue: No ]
    MARKO QoL questionnaire will be compared with other diagnostic tools used for evaluation of COPD patients (medical history, physical examination, spirometry parameters, diffusion capacity of lungs for carbon monoxide (DLCO), 6 minute walk test, The St George's Respiratory Questionnaire (SGRQ), lung function measured with COPD6 lung function screening device, COPD Assessment Test (CAT))

  • Prevalence of different stages of COPD (specifically GOLD stages 0 and I) in the population at risk for COPD and in general population [ Time Frame: 4 weeks after recruitment visit (2 yrs after start of recruitment) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum, plasma


Estimated Enrollment: 600
Study Start Date: October 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550679

Contacts
Contact: Davor Plavec, MD, PhD +38516391178 plavec@bolnica-srebrnjak.hr

Locations
Croatia
General Hospital Dubrovnik Not yet recruiting
Dubrovnik, Croatia, 20000
Contact: Žarko Vrbica, MD, MSc       zarkov@bolnica-du.hr   
Principal Investigator: Žarko Vrbica, MD, MSc         
University Hospital Rijeka Recruiting
Rijeka, Croatia, 51000
Contact: Ljiljana Bulat Kardum, MD, PhD    +38551407426    ljbulat@medri.hr   
Principal Investigator: Ljiljana Bulat Kardum, MD, PhD         
Clinical Hospital Center, Split Recruiting
Split, Croatia, 21000
Contact: Ivan Gudelj, MD, PhD       ivan.gudelj.1956@gmail.com   
Principal Investigator: Ivan Gudelj, MD, PhD         
Children's Hospital Srebrnjak Recruiting
Zagreb, Croatia, 10000
Contact: Davor Plavec, MD, PhD    +38516391178    plavec@bolnica-srebrnjak.hr   
Principal Investigator: Davor Plavec, MD, PhD         
Institute for Medical Research and Occupational Health, Zagreb Active, not recruiting
Zagreb, Croatia, 10000
Sponsors and Collaborators
Children's Hospital Srebrnjak
GlaxoSmithKline
University Hospital Rijeka
Clinical Hospital Center, Split
General Hospital Dubrovnik
Institute for Medical Research and Occupational Health, Zagreb
Investigators
Principal Investigator: Davor Plavec, MD, PhD Children's Hospital Srebrnjak
Principal Investigator: Žarko Vrbica, MD, MSc General Hospital Dubrovnik
  More Information

No publications provided

Responsible Party: Davor Plavec, Assist.Prof., MD, PhD, Children's Hospital Srebrnjak
ClinicalTrials.gov Identifier: NCT01550679     History of Changes
Other Study ID Numbers: CHSCRT114338, GSK eTrack number CRT114338
Study First Received: February 28, 2012
Last Updated: March 7, 2012
Health Authority: Croatia: Ministry of Health and Social Care

ClinicalTrials.gov processed this record on November 25, 2014