Prevalence of Severe Asthma in Spanish Hospitals

  • STATUS
    Not Recruiting
  • participants needed
    1600
  • sponsor
    GlaxoSmithKline
Updated on 20 June 2021
Investigator
US GSK Clinical Trials Call Center
Primary Contact
GSK Investigational Site (1.8 mi away) Contact
+46 other location
corticosteroids
theophylline

Summary

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).

Details
Condition Asthma, Allergies & Asthma, Asthma (Pediatric)
Treatment Questionnaire, Software of Big Data
Clinical Study IdentifierNCT03137043
SponsorGlaxoSmithKline
Last Modified on20 June 2021

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