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Pulmonary Disease, Chronic ObstructiveNCT03028207

A Cross-sectional Study on COPD Prevalence

An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 20 sites in Spain.

Completed

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

Official record
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Trial summary

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality worldwide and hence, estimating its prevalence is important. Since 2007, there are few data on the prevalence of COPD in the general population in Spain. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Medical tests and Questionnaire
How many people
9,362 participants
Where
20 sitesSpain
Study dates
9 Mar 2017to 1 Mar 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Study population includes individuals who, after the two telephone contacts, makes the study visit with the healthcare professional in the participating site and does not present any physical or cognitive difficulties that prevent conducting any of the study tests (e.g., spirometry, questionnaires).

Who may be able to join

  • Male and female subjects aged 40 years or older selected from the general population.
  • Subjects who have provided oral consent to participate in the brief telephone interview; these subjects will need to sign the informed consent to continue participating in the study.

Who cannot join

  • Subjects with any physical or cognitive difficulties which will prevent them from participating in any of the study tests (example, spirometry and questionnaires).
  • Subjects who are not located, dead or displaced.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Spain20 sites
  • GSK Investigational Site

    Avilés/Asturias, 33400

  • GSK Investigational Site

    Barcelona, 8035

  • GSK Investigational Site

    Burgos, 09006

  • GSK Investigational Site

    Cáceres, 10003

  • GSK Investigational Site

    Cartagena (Murcia), 30202

  • GSK Investigational Site

    Guadalajara, 19002

  • GSK Investigational Site

    Huesca, 22004

  • GSK Investigational Site

    La Laguna-Tenerife, 38320

  • GSK Investigational Site

    Logroño, 26006

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Oviedo, 33006

  • GSK Investigational Site

    Pama de Mallorca, 07010

  • GSK Investigational Site

    Pamplona, 31008

  • GSK Investigational Site

    Salamanca, 37007

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Seville, 41009

  • GSK Investigational Site

    Valencia, 46015

  • GSK Investigational Site

    Vigo-Pontevedra, 36312

  • GSK Investigational Site

    Vitoria-Gasteiz, 01004

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: New Study on the Prevalence of COPD in Spain EPI-Scan-II Study

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality worldwide and hence, estimating its prevalence is important. Since 2007, there are few data on the prevalence of COPD in the general population in Spain. The main objective of this epidemiological observational study is to estimate the prevalence of COPD in residents of Spain among the population over 40 years of age. The subjects will be distributed in two groups depending on the presence and absence of COPD. The study will have a single visit in which a brief interview will take place and subjects will need to complete the medical tests the case report form with a series of questionnaires. No drugs will be administered in this study.

Being tested
Medical tests, Questionnaire
Keywords
EPI-Scan-II Study, COPD, Epidemiology, Spain, Chronic Obstructive Pulmonary Disease, Prevalence, Cross-sectional
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

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

  • Medical testsProcedure or surgery

    During Visit 1, subjects will go through medical tests including spirometry, bronchodilation test, pulse oximetry, cooximetry, and bioimpedance. Additional tests will be performed at up to 9 centers such as pulmonary diffusion test, 6 minute walk test, CT during the same visit.

  • QuestionnaireOther

    During Visit 1, subjects will be given an Electronic Case Report Form (eCRF) with a series of questionnaire such as Health Related Quality of Life (HRQoL) CAT questionnaire, HADS anxiety scale, YPAS physical activity questionnaire, ECSC respiratory symptoms questionnaire, occupational exposure related questionnaire, MMSE questionnaire, Fagerstrom test, Prochaska test.

Study groups in NCT03028207
Study groupRoleWhat they receive
COPDSubjects with FEV1/FVC score less than 0.70 post-bronchodilator test will be allocated to COPD group and the prevalence of COPD will be evaluated. Subjects in this group will be categorized in 4 groups namely GOLD I - IV depending on the disease severity.
Receives: Procedure: Medical tests; Other: Questionnaire
Non-COPDSubjects with FEV1/FVC score greater than or equal to 0.70 post-bronchodilator test will be allocated to non-COPD group.
Receives: Procedure: Medical tests; Other: Questionnaire

What is being measured

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

  1. Number of subjects with COPD in Spain

    The prevalence of COPD in the subjects will be calculated according to the spirometric criteria, considering that a subject has COPD when the Forced Expiratory Volume in One Second/ Forced Vital Capacity (FEV1/FVC) obtained in post-bronchodilator spirometry is less than 0.7. The prevalence of COPD according to the Global initiative for Chronic Obstructive Lung Disease (GOLD) criteria will also be evaluated.

    Measured: Up to 9 months

Secondary outcomes (25)
  1. Number of COPD exacerbations

    The No. and type of COPD exacerbations in the past year will be described. Depending on the frequency, the subjects will be grouped into two categories: less than two exacerbations per year and two or more exacerbations per year.

    Measured: Up to 9 months

  2. Analysis of differences in the prevalence of COPD and its evolution time

    Previous studies such as IBERPOC or EPISCAN will be analyzed to compare differences in the prevalence of COPD and its evolution over time.

    Measured: Up to 9 months

  3. Estimation of COPD prevalence by age and sex

    Subjects in COPD cohort will be classified according to sex and age groups, and the association between prevalence and age will be explored from the chi-squared test and linear-by-linear association. The prevalence of COPD in different age and sex groups will be compared according to the FEV1/FVC ratio.

    Measured: Up to 9 months

  4. Number of subjects with comorbidities

    Presence of comorbidities among subjects with and without COPD will be evaluated using the Charlson and COPD specific comorbidity test (COTE indices), which associate long-term mortality with subject comorbidity.

    Measured: Up to 9 months

  5. Evaluation of COPD severity among subjects using the GOLD severity classification

    COPD severity according to GOLD criteria will be evaluated from the results of FEV1/FVC from the post-bronchodilator test. Subjects will be classified into 4 groups namely GOLD 1, GOLD 2, GOLD 3 and GOLD 4 for COPD severity with GOLD 1= mild and GOLD 4 = very severe COPD.

    Measured: Up to 9 months

  6. Analysis of distribution of subjects according to Spanish COPD Guide (GesEPOC)

    Subjects will be distributed based on GesEPOC into 4 phenotypes that determine differential treatment: non-exacerbator; mixed COPD-asthma; exacerbator with emphysema and exacerbator with chronic bronchitis.

    Measured: Up to 9 months

  7. Analysis of the risk factors of COPD

    The risk factors of COPD including level of physical activity, degree of smoking, occupational exposure and exposure to smoke from biomass combustion will be analyzed in COPD cohort.

    Measured: Up to 9 months

  8. Assessment of relationship between the diagnosis of COPD, symptoms, level of physical activity and smoking status

    The relationship between the diagnosis of COPD, the level of physical activity and smoking will be assessed first by describing physical activity and smoking based on study cohorts. In the subpopulation of subjects who are smokers, the score on the Fagerstrom Test calculated as the sum of the 6 items (0-10) will be described and it will also be categorized as follows: mild dependency (0-2), medium dependency (3-5) and high dependency (6-10), as well as the smoking cessation phase in which they are, as assessed by Prochaska's stage: pre-contemplation, contemplation, preparation, action, maintenance, termination and relapse.

    Measured: Up to 9 months

  9. Assessment of treatment received according to current guideline

    It will be assessed whether treatment received in the study's COPD population complies with current regulations. The rate of undertreatment and overtreatment in subjects with COPD will also be evaluated. The percentage of COPD subjects who are treated according to the provisions of GesEPOC and according to GOLD will be compared in a post hoc analysis.

    Measured: Up to 9 months

  10. Number of subjects with smoking habit

    The prevalence of smoking and electronic cigarette use in people of 40 years of age or older in Spain and by sex will be described.

    Measured: Up to 9 months

  11. Degree of nicotine dependence among subjects

    The level of nicotine dependence among smokers will be assessed using Fagerstrom test. The test will consist of 6 items and the final score will range from 0- 10 with higher score correlating with higher nicotine dependency. The phase of smoking cessation of subjects will also be assessed using the Prochaska's test. In this test, 3 questions will be asked to each subject. It will identify the smoker's time of addiction to tobacco based on a series of set stages: pre-contemplation, contemplation, preparation, action and maintenance.

    Measured: Up to 9 months

  12. Number of subjects with respiratory symptoms

    The presence and prevalence of specific respiratory symptoms such as chronic cough, dyspnea will be estimated using the European Coal and Steel Community (ECSC) respiratory symptoms questionnaire. The questions will be divided into 6 sections namely cough, expectoration, dyspnea, wheezing and intra-thoracic pressure, asthma attacks and treatments.

    Measured: Up to 9 months

  13. To evaluate Health Related Quality of Life (HRQoL) of subjects

    HRQoL will be evaluated by using the COPD Assessment Test (CAT) questionnaire. It will consist of a single dimension with 8 items, each with a response scale of 0 (no limitation) to 5 (very limited). The items will assess the degree of severity of cough, presence of mucus, chest pressure, dyspnea, limited domestic activities, social limitations and limited sleep and energy. The overall score will be described in a range of 0-40 points and will distribute subjects into two groups including CAT less than 10 (low impact of COPD) and CAT more than or equal to 10 (medium/high impact of COPD on the subject).

    Measured: Up to 9 months

  14. Number of subjects with possible cognitive impairment

    Possible cognitive impairment will be evaluated in subjects 60 years of age or older using mini-mental state examination (MMSE) questionnaire. It is a rapid screening test for dementia and its evolutionary staging. The test consists of 30 items and will explore five cognitive areas: orientation, fixation, concentration and calculation, memory and language. The total score will range from 0 to 30 points. If the score falls between 0-22, the subject will be considered to have a cognitive deficit and those achieving score from 23-30 will be concluded as subjects without a cognitive deficit.

    Measured: Up to 9 months

  15. Number of subjects with anxiety/depression

    The presence of anxiety and depression among the subjects will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS has two components that include scores for anxiety and depression. The response options are Likert-type, ranging from zero to three, giving a scoring range of 0-21 each. Depending on the HADS score, the subjects will be divided into 3 categories HADS 0-7 (absence of clinically relevant anxiety and/or depression), HADS 8-10 (likely to require consideration), HADS 11-21 (presence of anxiety/ depression relevant symptoms).

    Measured: Up to 9 months

  16. Evaluation of lean mass index among subjects

    The percentage of lean mass index will be evaluated and compared between COPD and non-COPD subjects by using bioimpedance. Body composition will be measured based on the electrical properties of biological tissues.

    Measured: Up to 9 months

  17. Evaluation of exercise tolerance among subjects

    Exercise tolerance between COPD and non-COPD subjects will be evaluated with the help of 6 minute walk test. The distance in meters and the reason for the stop will be measured, along with the initial and final heart rate and initial and final saturation of oxyhemoglobin (SatO2).

    Measured: Up to 9 months

  18. To evaluate daily physical activity of subjects

    The daily physical activity of COPD and non-COPD subjects will be compared using the Yale Physical Activity Survey (YPAS) questionnaire. YPAS will be calculated as the sum of the 5 sub-indices: index of vigorous activity, easy stroll index, moving index, standing index and sitting index. This index will range from 0 to 137 points. The subjects will be categorized into two groups namely YPAS less than 51 (sedentary subjects) and YPAS more than or equal to 51 (not sedentary subjects).

    Measured: Up to 9 months

  19. Recording of age

    Age will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in this study.

    Measured: Up to 9 months

  20. Number of subjects with different sociodemographic characteristics

    No. of subjects with different education level, gender, marital and smoking status will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in this study.

    Measured: Up to 9 months

  21. Recording of body mass index (BMI)

    BMI will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in this study.

    Measured: Up to 9 months

  22. Number of instances of underdiagnosis and overdiagnosis of COPD in subjects

    No. of instances of underdiagnosis will be described in the subsample of subjects who, despite declaring they had never received a previous diagnosis of COPD, reflect the presence of the disease from the study results. Also, the no. of instances of overdiagnosis will be described among those who claim having a prior diagnosis of COPD but who show this diagnosis to be unconfirmed after the study results. The correlation between the two variables will be analyzed using the Kappa index.

    Measured: Up to 9 months

  23. Number of subjects with abnormal multidimensional assessment of COPD

    No. of subjects with abnormal BMI, airflow Obstruction, Dyspnea and Exercise capacity (BODE) index ranging from 0-10 points and BMI, degree of dyspnea, pulmonary function and severe exacerbation (BODEX) index ranging from 0- 9 points will be recorded during multidimensional assessment of COPD.

    Measured: Up to 9 months

  24. Number of subjects with abnormal density of lung attenuation and thickness of airway caliber

    No. of subjects with attenuation of the lung parenchyma and thickness of the wall of the airway will be determined with the help of computed tomography (CT). No. of subjects with other abnormal parameters including the percentage of emphysema, extension areas, thickness of the airway, volume of the chest muscles, diameter of aorta vs. pulmonary artery, air trapping or coronary calcifications, bronchiectasis and fibrosis will also be assessed.

    Measured: Up to 9 months

  25. Number of subjects with dyspnea and other respiratory symptoms, health-related quality of life, exercise tolerance, physical activity and systemic inflammation among COPD and non-COPD subjects

    No. of subjects with intensity of dyspnea and other respiratory symptoms, health-related quality of life, exercise tolerance, physical activity and systemic inflammation will be assessed and compared between the COPD and non-COPD subjects depending on the amount of diffusion lung capacity.

    Measured: Up to 9 months

Timeline

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

  1. First posted23 Jan 2017 (estimated)
  2. Study start9 Mar 2017
  3. Primary completion1 Mar 2019
  4. Study completion1 Mar 2019

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
Cross-sectional
Enrolment
9,362 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03028207
Sponsor's protocol ID
205932
Status last verified
Jun 2019
First submitted
21 Nov 2016
Last updated
28 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Garcia-Rio F, Miravitlles M, Soriano JB, Cosio BG, Soler-Cataluna JJ, Casanova C, de Lucas P, Alfageme I, Rodriguez Gonzalez-Moro JM, Sanchez Herrero MG, Ancochea J; EPISCAN II study. Prevalence of reduced lung diffusing capacity and CT scan findings in smokers without airflow limitation: a population-based study. BMJ Open Respir Res. 2023 Jan;10(1):e001468. doi: 10.1136/bmjresp-2022-001468.

    PubMed 36707127
  • Alfageme I, de Lucas P, Ancochea J, Miravitlles M, Soler-Cataluna JJ, Garcia-Rio F, Casanova C, Rodriguez Gonzalez-Moro JM, Cosio BG, Sanchez G, Soriano JB. 10 Years After EPISCAN: A New Study on the Prevalence of COPD in Spain -A Summary of the EPISCAN II Protocol. Arch Bronconeumol (Engl Ed). 2019 Jan;55(1):38-47. doi: 10.1016/j.arbres.2018.05.011. Epub 2018 Jul 7. English, Spanish.

    PubMed 30612602

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 20 sites in Spain.

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 2 inclusion and 2 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 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain. 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?

Number of subjects with COPD in Spain (time frame: Up to 9 months). 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 NCT03028207, 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 28 Jun 2019.

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