Asthma Clinical Trial
Official title:
Observational Study to Describe the Prevalence of Severe Asthma in Spanish Hospitals
Asthma is a chronic disease. Prevalence of asthma in 2014 among Spanish population was 5%, of
which 10% were diagnosed with severe asthma. According to Spanish National Guideline for the
Management of Asthma (GEMA) 4.1 criteria, asthma can be classified according to its severity
(intermittent, mild persistent, moderate persistent or severe persistent) or level of asthma
control (controlled, partly controlled or uncontrolled). This Guideline describes that only 1
in 10 subjects with severe asthma is well controlled, meaning that there is a 90% prevalence
of non-controlled severe asthma.
This prospective, non-interventional, observational, multicenter and case-control study aims
to assess the prevalence of severe asthma in Spanish Hospitals. The study will describe the
characteristics of severe versus non-severe asthmatic subjects, assess their eligibility to
receive biological treatments approved for this disease, resource consumption and evaluate
the most prevalent phenotypes of severe asthma in Spain. Enrolled subjects will be divided
into two cohorts, based on asthma severity according to the Global Initiative for Asthma
(GINA) and the International European Respiratory Society (ERS)/American Thoracic Society
(ATS) Guidelines. Cohort A: subjects diagnosed of severe asthma and Cohort B: subjects with
non-severe asthma. Approximately 320 severe asthmatic subjects and 160 non-severe asthmatic
subjects will be enrolled in the study. A software of big data will be used to do a sub study
for comparing the results obtained through this software tool against results obtained
through Gold standard classical methods used in this prospective observational study (the
descriptive assessment of severe asthma prevalence and the prospective evolution of
subjects).
n/a
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