Clinical trial NCT03137043: Prevalence of Severe Asthma in Spanish Hospitals
Official title: Observational Study to Describe the Prevalence of Severe Asthma in Spanish Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: GINA guidelines
Prevalence
Mepolizumab
severe asthma
Spain
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Quintiles IMS
First posted: 2017-05-02
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The severe asthmatic subjects according to the ATS/ERS Guidelines will enter into the prospective phase of the study. Non-severe asthmatic subjects will be also enrolled as a control group.

Brief 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).


Eligibility criteria: Inclusion Criteria

* Group A: Subjects with Severe asthma can be enrolled, when they fulfill the following criteria:
* Subjects \>= 18 years
* Subjects diagnosed with "severe asthma" defined as asthma that requires high-dose inhaled corticosteroids (ICS) plus Long-Acting Beta2-Agonist (LABA), leukotriene modifier/ theophylline in the last 12 months or continuous/almost continuous treatment with systemic glucocorticosteroids (CS) for \>= 50% of the previous year to maintain control of asthma
* Subjects treated with ICS/LABA, with the maximum dose recommended by Specific Product Characteristics (SPC).
* Subjects who give voluntary written informed consent after explanation of study´s procedures.
* Group B: Subjects with Non-Severe asthma can be enrolled, when they fulfill the following criteria:
* Subjects \>= 18 years
* Subjects diagnosed with non-severe asthma per GINA Guidelines Classification
* Subjects who give voluntary written informed consent after explanation of study´s procedures

Exclusion Criteria

* Subjects who are not able to complete all the follow-ups of the study with all the study procedures

Primary outcomes:
measure: To estimate the prevalence of severe asthmatic subjects at Spanish sites
timeFrame: Up to 12 months
Secondary outcomes:
measure: Number of subjects with sociodemographic characteristics of severe asthmatic subjects compared to non-severe asthmatic subjects
timeFrame: Up to 12 months
measure: Number of subjects with clinical characteristics of severe asthmatic subjects compared to non-severe asthmatic subjects
timeFrame: Up to 12 months
measure: To estimate the prevalence of different phenotypes in severe asthma
timeFrame: Up to 12 months
measure: Number of subjects who comply with eligibility criteria to receive biological treatment for severe asthma
timeFrame: Up to 12 months
measure: Number of subjects evolved with severe asthma and non-severe asthma at 6 and 12 months from baseline
timeFrame: Up to 12 months
measure: Number of subjects evolved with severe asthma in comparison with non severe asthma at 6 and 12 months
timeFrame: Up to 12 months
measure: To assess the social impact of subjects with severe asthma in comparison with non-severe asthmatic subjects in terms of Health Related Quality of Life (HRQoL)
timeFrame: Up to 12 months
measure: To assess the use of healthcare resources (direct and indirect) in subjects with severe asthma and non-severe asthma
timeFrame: Up to 12 months
measure: To predict evolution of subjects with severe and non-severe asthma at month 6 and month 12, based on the physician's experience and knowledge, compared to results obtained through monitoring
timeFrame: Up to 12 months
measure: To establish the determinant factors clinicians use, to predict subjects evolution
timeFrame: Up to 12 months
measure: To test if the calculated prevalence using a specific software is similar to the prevalence of severe asthma obtained through monitoring using gold standard
timeFrame: Up to 12 months
measure: To compare the prediction in the evolution of subjects with severe asthma at 6 and 12 months, based on the aggregated information collected in the last 5 years previous to the start of the observational study with the prediction done by the physician
timeFrame: Up to 12 months
measure: To compare the software's prediction in the evolution of subjects with severe asthma at 6 and 12 months with the results obtained by monitoring in the observational study
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Laredo
country: Spain
facility: GSK Investigational Site
state: Cantabria
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Cartagena (Murcia)
country: Spain
facility: GSK Investigational Site
city: Cáceres
country: Spain
facility: GSK Investigational Site
city: Elda (Alicante)
country: Spain
facility: GSK Investigational Site
city: L'Hospitalet de Llobregat
country: Spain
facility: GSK Investigational Site
city: La Coruña
country: Spain
facility: GSK Investigational Site
city: La Laguna-Tenerife
country: Spain
facility: GSK Investigational Site
city: Loja/ Granada
country: Spain
facility: GSK Investigational Site
city: Lérida
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Majadahonda (Madrid)
country: Spain
facility: GSK Investigational Site
city: Marbella
country: Spain
facility: GSK Investigational Site
city: Murcia (El Palmar)
country: Spain
facility: GSK Investigational Site
city: Pamplona
country: Spain
facility: GSK Investigational Site
city: Ponferrada (León)
country: Spain
facility: GSK Investigational Site
city: Sagunto/Valencia
country: Spain
facility: GSK Investigational Site
city: Salamanca
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Valdemoro/Madrid
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Xátiva-Valencia
country: Spain
facility: GSK Investigational Site
city: Zaragoza
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: Almonacid Sanchez C, Melero Moreno C, Quirce Gancedo S, Sanchez-Herrero MG, Alvarez Gutierrez FJ, Banas Conejero D, Cardona V, Soriano JB. PAGE Study: Summary of a Study Protocol to Estimate the Prevalence of Severe Asthma in Spain Using Big Data Methods. J Investig Allergol Clin Immunol. 2021 Jul 26;31(4):308-315. doi: 10.18176/jiaci.0483. Epub 2020 Jan 23.