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

COPD Clinical Trial

— MARKO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550679
• Other study ID #: CHSCRT114338
• Secondary ID: GSK eTrack numbe
• Status: Completed
• Start date: October 2010
• Est. completion date: April 2020

Study information

• Verified date: December 2020
• Source: Children's Hospital Srebrnjak
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• COPD
• Other Diagnoses, Comorbidities, and Complications
• Smoking

Locations

Country	Name	City	State
Croatia	General Hospital Dubrovnik	Dubrovnik
Croatia	University Hospital Osijek	Osijek	Slavonsko-Baranjska
Croatia	University Hospital Rijeka	Rijeka
Croatia	Clinical Hospital Center, Split	Split
Croatia	Children's Hospital Srebrnjak	Zagreb
Croatia	Institute for Medical Research and Occupational Health, Zagreb	Zagreb

Sponsors (7)

Lead Sponsor	Collaborator
Children's Hospital Srebrnjak	Clinical Hospital Center, Split, General Hospital Dubrovnik, GlaxoSmithKline, Institute for Medical Research and Occupational Health, Zagreb, Osijek University Hospital, University Hospital Rijeka

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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
Primary	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	Prevalence of concomitant disorders in this population		4 weeks after recruitment visit (2 yrs after start of recruitment)
Secondary	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.	4 weeks after recruitment visit (2 yrs after start of recruitment)
Secondary	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
Secondary	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))	After 2 years, 3 years, and 5 years of follow-up
Secondary	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)