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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- 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 group | Role | What they receive |
|---|---|---|
| COPD | Subjects 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-COPD | Subjects 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted23 Jan 2017 (estimated)
- Study start9 Mar 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IMS Health
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
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 36707127Alfageme 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Study on the Prevalence of COPD in Spain EPI-Scan-II Study
- ClinicalTrials.gov ID
- NCT03028207
- Acronym / sponsor ID
- 205932
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- EPI-Scan-II Study, COPD, Epidemiology, Spain, Chronic Obstructive Pulmonary Disease, Prevalence, Cross-sectional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,362 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- IMS Health
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD | – | Procedure: Medical tests, Other: QuestionnaireSubjects 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. |
| Non-COPD | – | Procedure: Medical tests, Other: QuestionnaireSubjects with FEV1/FVC score greater than or equal to 0.70 post-bronchodilator test will be allocated to non-COPD group. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical testsDuring 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. | Procedure or surgery | COPD, Non-COPD |
| QuestionnaireDuring 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. | Other | COPD, Non-COPD |
Primary outcome
Number of subjects with COPD in Spain
Time frame: Up to 9 months
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.
25 secondary outcomes
Number of COPD exacerbations
Time frame: Up to 9 months
Analysis of differences in the prevalence of COPD and its evolution time
Time frame: Up to 9 months
Estimation of COPD prevalence by age and sex
Time frame: Up to 9 months
Number of subjects with comorbidities
Time frame: Up to 9 months
Evaluation of COPD severity among subjects using the GOLD severity classification
Time frame: Up to 9 months
Analysis of distribution of subjects according to Spanish COPD Guide (GesEPOC)
Time frame: Up to 9 months
Analysis of the risk factors of COPD
Time frame: Up to 9 months
Assessment of relationship between the diagnosis of COPD, symptoms, level of physical activity and smoking status
Time frame: Up to 9 months
Assessment of treatment received according to current guideline
Time frame: Up to 9 months
Number of subjects with smoking habit
Time frame: Up to 9 months
Degree of nicotine dependence among subjects
Time frame: Up to 9 months
Number of subjects with respiratory symptoms
Time frame: Up to 9 months
To evaluate Health Related Quality of Life (HRQoL) of subjects
Time frame: Up to 9 months
Number of subjects with possible cognitive impairment
Time frame: Up to 9 months
Number of subjects with anxiety/depression
Time frame: Up to 9 months
Evaluation of lean mass index among subjects
Time frame: Up to 9 months
Evaluation of exercise tolerance among subjects
Time frame: Up to 9 months
To evaluate daily physical activity of subjects
Time frame: Up to 9 months
Recording of age
Time frame: Up to 9 months
Number of subjects with different sociodemographic characteristics
Time frame: Up to 9 months
Recording of body mass index (BMI)
Time frame: Up to 9 months
Number of instances of underdiagnosis and overdiagnosis of COPD in subjects
Time frame: Up to 9 months
Number of subjects with abnormal multidimensional assessment of COPD
Time frame: Up to 9 months
Number of subjects with abnormal density of lung attenuation and thickness of airway caliber
Time frame: Up to 9 months
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
Time frame: Up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Derived from this study: PubMed 36707127Garcia-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.
- Derived from this study: PubMed 30612602Alfageme 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
20 sites in 1 country: see every site and its status.
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.