Prevalence of Severe Asthma in Spanish Hospitals

Asthma Clinical Trial

Official title:

Observational Study to Describe the Prevalence of Severe Asthma in Spanish Hospitals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137043
• Other study ID #: 205807
• Status: Completed
• Start date: November 22, 2017
• Est. completion date: June 2, 2020

Study information

• Verified date: September 2020
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: June 2, 2020
• Est. primary completion date: June 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Cáceres
Spain	GSK Investigational Site	Cartagena (Murcia)
Spain	GSK Investigational Site	Elda (Alicante)
Spain	GSK Investigational Site	L'Hospitalet de Llobregat
Spain	GSK Investigational Site	La Coruña
Spain	GSK Investigational Site	La Laguna-Tenerife
Spain	GSK Investigational Site	Laredo	Cantabria
Spain	GSK Investigational Site	Lérida
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	Sevilla
Spain	GSK Investigational Site	Sevilla
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

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Quintiles IMS

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Almonacid Sánchez C, Melero Moreno C, Quirce Gancedo S, Sánchez-Herrero MG, Álvarez Gutiérrez FJ, Bañas 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. 2020 Jan 23:0. doi: 10.18176/jiaci.0483. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of subjects with sociodemographic characteristics of severe asthmatic subjects compared to non-severe asthmatic subjects	Subjects with different age, gender, ethnicity, education, occupational status, marital status, physical examination, smoking status, family history, co-morbidities and allergies will be compared for descriptive analysis of sociodemographic characteristics of subjects with severe asthma and non-severe asthma participating in this study.	Up to 12 months
Secondary	Number of subjects with clinical characteristics of severe asthmatic subjects compared to non-severe asthmatic subjects	Subjects with asthma severity, age of asthma onset, laboratory tests, biomarkers, skin prick test, airflow tests, asthma symptoms and exacerbations will be compared for clinical characteristics analysis of subjects with severe asthma and non-severe asthma participating in this study.	Up to 12 months
Secondary	To estimate the prevalence of different phenotypes in severe asthma	Prevalence of different severe asthma phenotypes (allergic, base on prick test, Immunoglobulin E (IgE), eosinophilic, based on eosinophils counts >= 300 cells/millimeter cubed in blood samples in the previous year, obesity, based on the absence of positive prick test, IgE or high eosinophils counts in blood sample; neutrophilic, just in case eosinophils in sputum are available.	Up to 12 months
Secondary	Number of subjects who comply with eligibility criteria to receive biological treatment for severe asthma	Number of exacerbations; Oral Corticosteroid (OCS) treatment; Number of visits to emergency room (ER) and/or hospitalization within the last 12 months, sputum eosinophils (if done), eosinophils in blood, IgE (specific and total), forced expiratory volume-one second (FEV1), Asthma Control Test (ACT), percentage of reversibility will be assessed.	Up to 12 months
Secondary	Number of subjects evolved with severe asthma and non-severe asthma at 6 and 12 months from baseline	Exacerbations; visits to emergency room; changes in treatment or dose increase, add-on therapy addition, Disease control (3-score change in ACT), Disease control state (uncontrolled, partially controlled, well controlled) according to guidelines, Quality of life (4-score change in SGRQ), mortality will be assessed.	Up to 12 months
Secondary	Number of subjects evolved with severe asthma in comparison with non severe asthma at 6 and 12 months	Subjects with severe and non severe asthma at 6 and 12 months will be compared.	Up to 12 months
Secondary	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)	Health Related Quality of Life (HRQoL) will be analyzed from the SGRQ Questionnaire scores. Scores will be expressed as percentage of overall impairment, where 100 represents worst possible health and 0 indicates best possible health status.	Up to 12 months
Secondary	To assess the use of healthcare resources (direct and indirect) in subjects with severe asthma and non-severe asthma	Direct resources will include number of inpatient admissions, emergency and hospitalized visits, tests to be conducted, etc. on patients with severe asthma. The medical resources used (tests, admissions, etc.) will be analyzed descriptively during the observation period. The direct cost will be calculated by taking into account the resources used and unit costs at a local level. Indirect resources will include reduced productivity of patients with severe asthma through an ad-hoc questions like total number of work days lost due to asthma in the last 6 months.	Up to 12 months
Secondary	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	The variables to be predicted will be exacerbations; visits to ER; changes in treatment or dose increase; add-on therapy addition; disease control (3-score change in ACT); disease control state (uncontrolled, partially controlled, well controlled) according to guidelines, Quality of life (4-score change in SGRQ) and mortality will be assessed.	Up to 12 months
Secondary	To establish the determinant factors clinicians use, to predict subjects evolution	FEV1 (pre & post), percentage reversibility FEV1, number of exacerbations, use of rescue medication, changes to the treatment required, need for adding a biological treatment, concomitant diseases or comorbidities, asthma symptoms; tobacco, eosinophils in blood or sputum, Asthma Control measured by ACT, number or hospitalizations; number of emergency department visits; dose of inhaled glucocorticosteroids, need and dose of oral glucocortocosteroids, mortality, adherence to medication, inhaler technique, fractionated exhaled nitric oxide level (FeNO), Body Mass Index (BMI), GINA treatment Step, living in a rural environment, chronic obstructive pulmonary disease (COPD), male sex, black race, lower educational level will be the determining factor for clinicians.	Up to 12 months
Secondary	To test if the calculated prevalence using a specific software is similar to the prevalence of severe asthma obtained through monitoring using gold standard	This will provide a descriptive comparison between the gold standard data and the software's prediction.	Up to 12 months
Secondary	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	This will provide a descriptive comparison between the clinician's prediction and the software's prediction.	Up to 12 months
Secondary	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	Gold standard data collected by monitoring will be compared against the real data.	Up to 12 months