Last updated: 11/09/2020 23:50:37
A cross-sectional study on COPD prevalence
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: New Study on the Prevalence of COPD in Spain EPI-Scan-II Study
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects with COPD in Spain
Timeframe: Up to 9 months
Secondary outcomes:
Number of COPD exacerbations
Timeframe: Up to 9 months
Analysis of differences in the prevalence of COPD and its evolution time
Timeframe: Up to 9 months
Estimation of COPD prevalence by age and sex
Timeframe: Up to 9 months
Number of subjects with comorbidities
Timeframe: Up to 9 months
Evaluation of COPD severity among subjects using the GOLD severity classification
Timeframe: Up to 9 months
Analysis of distribution of subjects according to Spanish COPD Guide (GesEPOC)
Timeframe: Up to 9 months
Analysis of the risk factors of COPD
Timeframe: Up to 9 months
Assessment of relationship between the diagnosis of COPD, symptoms, level of physical activity and smoking status
Timeframe: Up to 9 months
Assessment of treatment received according to current guideline
Timeframe: Up to 9 months
Number of subjects with smoking habit
Timeframe: Up to 9 months
Degree of nicotine dependence among subjects
Timeframe: Up to 9 months
Number of subjects with respiratory symptoms
Timeframe: Up to 9 months
To evaluate Health Related Quality of Life (HRQoL) of subjects
Timeframe: Up to 9 months
Number of subjects with possible cognitive impairment
Timeframe: Up to 9 months
Number of subjects with anxiety/depression
Timeframe: Up to 9 months
Evaluation of lean mass index among subjects
Timeframe: Up to 9 months
Evaluation of exercise tolerance among subjects
Timeframe: Up to 9 months
To evaluate daily physical activity of subjects
Timeframe: Up to 9 months
Recording of age
Timeframe: Up to 9 months
Number of subjects with different sociodemographic characteristics
Timeframe: Up to 9 months
Recording of body mass index (BMI)
Timeframe: Up to 9 months
Number of instances of underdiagnosis and overdiagnosis of COPD in subjects
Timeframe: Up to 9 months
Number of subjects with abnormal multidimensional assessment of COPD
Timeframe: Up to 9 months
Number of subjects with abnormal density of lung attenuation and thickness of airway caliber
Timeframe: 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
Timeframe: Up to 9 months
Interventions:
Procedure/surgery: Medical tests
Other: Questionnaire
Enrollment:
9362
Observational study model:
Cohort
Primary completion date:
2019-01-03
Time perspective:
Cross-Sectional
Clinical publications:
Joan B Soriano, Inmaculada Alfageme, Marc Miravitlles, Pilar de Lucas, Juan José Soler-Cataluña, Francisco García-Río, Ciro Casanova, José Miguel Rodríguez González-Moro, Borja G. Cosío, Guadalupe Sánchez, Julio Ancochea. Prevalence and determinants of COPD in Spain: EPISCAN II. Arch Bronconeumol. 2020;
DOI: 10.1016/j.arbres.2020.07.024
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
IMS Health
Study date(s)
March 2017 to March 2019
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2019-01-03
Actual study completion date
2019-01-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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