Last updated: 10/04/2022 09:00:14
Prevalence of Severe Asthma in Spanish Hospitals
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Observational Study to describe the Prevalence of Severe Asthma in Spanish Hospitals
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
To estimate the prevalence of severe asthmatic subjects at Spanish sites
Timeframe: Up to 12 months
Secondary outcomes:
Number of subjects with sociodemographic characteristics of severe asthmatic subjects compared to non-severe asthmatic subjects
Timeframe: Up to 12 months
Number of subjects with clinical characteristics of severe asthmatic subjects compared to non-severe asthmatic subjects
Timeframe: Up to 12 months
To estimate the prevalence of different phenotypes in severe asthma
Timeframe: Up to 12 months
Number of subjects who comply with eligibility criteria to receive biological treatment for severe asthma
Timeframe: Up to 12 months
Number of subjects evolved with severe asthma and non-severe asthma at 6 and 12 months from baseline
Timeframe: Up to 12 months
Number of subjects evolved with severe asthma in comparison with non severe asthma at 6 and 12 months
Timeframe: Up to 12 months
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
To assess the use of healthcare resources (direct and indirect) in subjects with severe asthma and non-severe asthma
Timeframe: Up to 12 months
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
To establish the determinant factors clinicians use, to predict subjects evolution
Timeframe: Up to 12 months
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
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
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
Interventions:
Other: Questionnaire
Other: Software of Big Data
Enrollment:
356
Observational study model:
Case-Control
Primary completion date:
2020-02-06
Time perspective:
Prospective
Clinical publications:
Carlos Almonacid Sánchez, Carlos Melero Moreno, Santiago Quirce Gancedo, Maria Guadalupe Sánchez Herrero, Francisco Javier Álvarez, David Banas, Victoria Cardona Dahl, Joan B Soriano Ortiz.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.2020;
Melero C, Almonacid C, Bañas D, Quirce S, Álvarez FJ, Cardona Dahl, V, Sánchez-Herrero MG, Soriano J. Understanding severe asthma through small and big data in Spanish hospitals - PAGE Study. J Investig Allergol Clin Immunol. 2022;33(5)
DOI: 10.18176/jiaci.0848
PMID: 36000822
Medical condition
Asthma
Product
mepolizumab
Collaborators
Quintiles IMS
Study date(s)
November 2017 to June 2020
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Inclusion Criteria
- Group A: Subjects with Severe asthma can be enrolled, when they fulfill the following criteria:
Inclusion and exclusion criteria
Inclusion 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
Trial location(s)
Location
GSK Investigational Site
L'Hospitalet de Llobregat, Spain, 08907
Status
Study Complete
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2020-02-06
Actual study completion date
2020-02-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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