AzTrials
AzTrials

COPDMARKONCT01550679

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

An observational study of COPD and Smoking, run by Children's Hospital Srebrnjak at 6 sites in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 yearsHealthy volunteers can take part
How many people
450 participants
Where
6 sitesCroatia
Study dates
Oct 2010to Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Primary care clinic

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

6 sites in 1 country.

6 sites in 1 country

Croatia6 sites

  • General Hospital Dubrovnik

    Dubrovnik, 20000

  • University Hospital Osijek

    Osijek, Slavonsko-Baranjska, 31000

  • University Hospital Rijeka

    Rijeka, 51000

  • Clinical Hospital Center, Split

    Split, 21000

  • Children's Hospital Srebrnjak

    Zagreb, 10000

  • Institute for Medical Research and Occupational Health, Zagreb

    Zagreb, 10000

Other trials in Croatia

About this study

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.

Medical subject headings
Pulmonary Disease, Chronic Obstructive, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01550679
Study groupRoleWhat they receive
Smokers or ex-smokersSmokers 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Secondary outcomes (5)

  1. Prevalence of concomitant disorders in this population

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

  2. Sensitivity of diagnostic parameters for early impairment in COPD

    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.

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

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

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

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

    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))

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2012 (estimated)
  2. Study startOct 2010
  3. Primary completionApr 2020
  4. Study completionApr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01550679
Sponsor's protocol ID
CHSCRT114338
Other IDs
GSK eTrack number CRT114338
Acronym
MARKO
Status last verified
Dec 2020
First submitted
28 Feb 2012
Last updated
29 Dec 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28187733

  • 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.

    PubMed 27542843

Questions about this trial

What is this clinical trial studying?

An observational study of COPD and Smoking, run by Children's Hospital Srebrnjak at 6 sites in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inner consistency, repeatability, intelligibility, and applicability of MARKO questionnaire (time frame: 4 weeks after recruitment visit (2 yrs after start of recruitment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01550679, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in