Prevalence of Severe Asthma in Spanish Hospitals

NCT03137043 | Completed

• 1 other identifier: 205807
• Study Type: observational
• Target: 356
• Locations: 1 country
• Sites: 33

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

Keywords

GINA guidelines; Prevalence; Mepolizumab; severe asthma; Spain

Outcome Measures

Primary Outcomes (1)

• To estimate the prevalence of severe asthmatic subjects at Spanish sites

  Assessment will be done based on the type of hospital, department type of hospital or clinic, sources of the service and number of asthmatic subjects diagnosed according to GEMA guidelines.

  Up to 12 months

Secondary Outcomes (13)

• Number of subjects with sociodemographic characteristics of severe asthmatic subjects compared to non-severe asthmatic subjects

  Up to 12 months

• Number of subjects with clinical characteristics of severe asthmatic subjects compared to non-severe asthmatic subjects

  Up to 12 months

• To estimate the prevalence of different phenotypes in severe asthma

  Up to 12 months

• Number of subjects who comply with eligibility criteria to receive biological treatment for severe asthma

  Up to 12 months

• Number of subjects evolved with severe asthma and non-severe asthma at 6 and 12 months from baseline

  Up to 12 months

Study Arms (2)

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.

Other: Questionnaire; Other: Software of Big Data

Non-Severe Asthmatic Subjects

Subjects with intermittent, persistent mild or moderate asthma.

Other: Questionnaire; Other: Software of Big Data

Interventions

Questionnaire 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.

Non-Severe Asthmatic Subjects; Severe Asthmatic Subjects

Software of Big Data 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; Severe Asthmatic Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Quintiles IMS: collaborator

Study Sites (33)

GSK Investigational Site

Laredo, Cantabria, 39770, Spain

Location

GSK Investigational Site

A Coruña, 15006, Spain

Location

GSK Investigational Site

Badalona, 08916, Spain

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Cartagena (Murcia), 30202, Spain

Location

GSK Investigational Site

Cáceres, 10003, Spain

Location

GSK Investigational Site

Elda (Alicante), 03600, Spain

Location

GSK Investigational Site

L'Hospitalet de Llobregat, 08907, Spain

Location

GSK Investigational Site

La Laguna-Tenerife, 38320, Spain

Location

GSK Investigational Site

Lleida, 25198, Spain

Location

GSK Investigational Site

Loja/ Granada, 18300, Spain

Location

GSK Investigational Site

Madrid, 28006, Spain

Location

GSK Investigational Site

Madrid, 28007, Spain

Location

GSK Investigational Site

Madrid, 28031, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Majadahonda (Madrid), 28222, Spain

Location

GSK Investigational Site

Marbella, 29600, Spain

Location

GSK Investigational Site

Murcia (El Palmar), 30120, Spain

Location

GSK Investigational Site

Pamplona, 31008, Spain

Location

GSK Investigational Site

Ponferrada (León), 24411, Spain

Location

GSK Investigational Site

Sagunto/Valencia, 46520, Spain

Location

GSK Investigational Site

Salamanca, 37007, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15706, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

GSK Investigational Site

Seville, 41071, Spain

Location

GSK Investigational Site

Valdemoro/Madrid, 28340, Spain

Location

GSK Investigational Site

Valencia, 46017, Spain

Location

GSK Investigational Site

Valencia, 46026, Spain

Location

GSK Investigational Site

Xátiva-Valencia, 46800, Spain

Location

GSK Investigational Site

Zaragoza, 50009, Spain

Location

GSK Investigational Site

Zaragoza, 50015, Spain

Location

Related Publications (1)

• 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.

  PMID: 31983679 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 2, 2017
• Study Start: November 22, 2017
• Primary Completion: June 2, 2020
• Study Completion: June 2, 2020
• Last Updated: September 21, 2020

Record last verified: 2020-09

Locations

ES (33)