Prevalence of Severe Asthma in Spanish Hospitals

NCT ID: NCT03137043

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 356 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-22
• Study Completion Date: 2020-06-02

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).

Conditions

Asthma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Severe Asthmatic Subjects

Subjects requiring high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic glucocorticosteroids) to prevent it from becoming 'uncontrolled' or which remains 'uncontrolled' despite the therapy.

Questionnaire

Intervention Type: OTHER

Subjects will be given an Electronic Case Report Form (eCRF) with a series of questionnaire such as Asthma Control Test, Morisky-Green Questionnaire and St George's Respiratory Questionnaire.

Software of Big Data

Intervention Type: OTHER

Software of big data is a powerful data treatment algorithm works closely with Spanish Data Protection Agency as an example on how to reuse clinical information without conflicting with necessary data privacy. The system will process a vast amount of information (big data), so that the impact of random errors will be minimized.

Non-Severe Asthmatic Subjects

Subjects with intermittent, persistent mild or moderate asthma.

Questionnaire

Intervention Type: OTHER

Subjects will be given an Electronic Case Report Form (eCRF) with a series of questionnaire such as Asthma Control Test, Morisky-Green Questionnaire and St George's Respiratory Questionnaire.

Software of Big Data

Intervention Type: OTHER

Software of big data is a powerful data treatment algorithm works closely with Spanish Data Protection Agency as an example on how to reuse clinical information without conflicting with necessary data privacy. The system will process a vast amount of information (big data), so that the impact of random errors will be minimized.

Interventions

Questionnaire

Subjects will be given an Electronic Case Report Form (eCRF) with a series of questionnaire such as Asthma Control Test, Morisky-Green Questionnaire and St George's Respiratory Questionnaire.

Intervention Type: OTHER

Software of Big Data

Software of big data is a powerful data treatment algorithm works closely with Spanish Data Protection Agency as an example on how to reuse clinical information without conflicting with necessary data privacy. The system will process a vast amount of information (big data), so that the impact of random errors will be minimized.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quintiles IMS

UNKNOWN

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Laredo, Cantabria, Spain

GSK Investigational Site

A Coruña, , Spain

GSK Investigational Site

Badalona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Cartagena (Murcia), , Spain

GSK Investigational Site

Cáceres, , Spain

GSK Investigational Site

Elda (Alicante), , Spain

GSK Investigational Site

L'Hospitalet de Llobregat, , Spain

GSK Investigational Site

La Laguna-Tenerife, , Spain

GSK Investigational Site

Lleida, , Spain

GSK Investigational Site

Loja/ Granada, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Majadahonda (Madrid), , Spain

GSK Investigational Site

Marbella, , Spain

GSK Investigational Site

Murcia (El Palmar), , Spain

GSK Investigational Site

Pamplona, , Spain

GSK Investigational Site

Ponferrada (León), , Spain

GSK Investigational Site

Sagunto/Valencia, , Spain

GSK Investigational Site

Salamanca, , Spain

GSK Investigational Site

Santiago de Compostela, , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Valdemoro/Madrid, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Xátiva-Valencia, , Spain

GSK Investigational Site

Zaragoza, , Spain

GSK Investigational Site

Zaragoza, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 31983679 (View on PubMed)

Other Identifiers

205807

Identifier Type: -

Identifier Source: org_study_id