Clinical trial NCT03028207: A Cross-sectional Study on COPD Prevalence
Official title: New Study on the Prevalence of COPD in Spain EPI-Scan-II Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: EPI-Scan-II Study
COPD
Epidemiology
Spain
Chronic Obstructive Pulmonary Disease
Prevalence
Cross-sectional
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: IMS Health
First posted: 2017-01-23
Enrollment: 9362
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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).

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of subjects with COPD in Spain
timeFrame: Up to 9 months
Secondary outcomes:
measure: Number of COPD exacerbations
timeFrame: Up to 9 months
measure: Analysis of differences in the prevalence of COPD and its evolution time
timeFrame: Up to 9 months
measure: Estimation of COPD prevalence by age and sex
timeFrame: Up to 9 months
measure: Number of subjects with comorbidities
timeFrame: Up to 9 months
measure: Evaluation of COPD severity among subjects using the GOLD severity classification
timeFrame: Up to 9 months
measure: Analysis of distribution of subjects according to Spanish COPD Guide (GesEPOC)
timeFrame: Up to 9 months
measure: Analysis of the risk factors of COPD
timeFrame: Up to 9 months
measure: Assessment of relationship between the diagnosis of COPD, symptoms, level of physical activity and smoking status
timeFrame: Up to 9 months
measure: Assessment of treatment received according to current guideline
timeFrame: Up to 9 months
measure: Number of subjects with smoking habit
timeFrame: Up to 9 months
measure: Degree of nicotine dependence among subjects
timeFrame: Up to 9 months
measure: Number of subjects with respiratory symptoms
timeFrame: Up to 9 months
measure: To evaluate Health Related Quality of Life (HRQoL) of subjects
timeFrame: Up to 9 months
measure: Number of subjects with possible cognitive impairment
timeFrame: Up to 9 months
measure: Number of subjects with anxiety/depression
timeFrame: Up to 9 months
measure: Evaluation of lean mass index among subjects
timeFrame: Up to 9 months
measure: Evaluation of exercise tolerance among subjects
timeFrame: Up to 9 months
measure: To evaluate daily physical activity of subjects
timeFrame: Up to 9 months
measure: Recording of age
timeFrame: Up to 9 months
measure: Number of subjects with different sociodemographic characteristics
timeFrame: Up to 9 months
measure: Recording of body mass index (BMI)
timeFrame: Up to 9 months
measure: Number of instances of underdiagnosis and overdiagnosis of COPD in subjects
timeFrame: Up to 9 months
measure: Number of subjects with abnormal multidimensional assessment of COPD
timeFrame: Up to 9 months
measure: Number of subjects with abnormal density of lung attenuation and thickness of airway caliber
timeFrame: Up to 9 months
measure: 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
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Avilés/Asturias
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Burgos
country: Spain
facility: GSK Investigational Site
city: Caceres
country: Spain
facility: GSK Investigational Site
city: Cartagena (Murcia)
country: Spain
facility: GSK Investigational Site
city: Guadalajara
country: Spain
facility: GSK Investigational Site
city: Huesca
country: Spain
facility: GSK Investigational Site
city: La Laguna-Tenerife
country: Spain
facility: GSK Investigational Site
city: Logroño
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Oviedo
country: Spain
facility: GSK Investigational Site
city: Pama de Mallorca
country: Spain
facility: GSK Investigational Site
city: Pamplona
country: Spain
facility: GSK Investigational Site
city: Salamanca
country: Spain
facility: GSK Investigational Site
city: Santander
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Vigo-Pontevedra
country: Spain
facility: GSK Investigational Site
city: Vitoria
country: Spain
facility: GSK Investigational Site
city: Zaragoza
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.