Study type

Study topic

Disease /health condition
Other

Study topic, other

Disease/Epidemiology Study

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Asthma
Asthmatic crisis
Population studied

Short description of the study population

Asthma patients with exacerbations of the Valencian Community.

Inclusion critera:
1. General cohort of asthmatic patients. All persons 18 and over years of age (fulfilled between 2010 and 2018) were included who have at least one diagnosis of
asthma (ICD9MC: 493.xx, ICD10MC: J45) in any of the information systems used (SIA, MBDS, SIUH).
2. Exacerbation cohort: Cases were selected from the general cohort who have at least one exacerbation episode between 2015 and 2016, excluding those older than 55 years on the date of the index exacerbation. The first episode of exacerbation in this period were considered the index episode and will define the onset of the follow-up period

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Special population of interest

Hepatic impaired
Immunocompromised
Pregnant women
Renal impaired

Estimated number of subjects

15000
Study design details

Main study objective

To describe the incidence and prevalence of asthma in the region of Valencia and to describe the characteristics of asthmatic patients with exacerbations, the pharmacotherapeutic management patterns after exacerbation, and the use of associated health care resources, from a real-world population cohort that includes the entire population of asthma patients with exacerbaiton of the region.

Outcomes

To describe the characteristics of asthmatic patients with exacerbations (socio-demographic characteristics, comorbidities, clinical risk.To describe the pharmacotherapeutic management of these patients following the index exacerbation.To describe the use of healthcare resources, the deaths and the loss of productivity (days of sick leave) in the year following the index exacerbation. To describe the incidence of asthma in the reion of Valencian over the study period (cohort 2010 - 2018).To describe the incidence of asthma exacerbations, deaths and days of sick leave in the Valencian Community over the study period (2015 to 2017).To analyse the association between baseline risk (history of pattern of exacerbation and therapeutic step) and the risk of future exacerbations.

Data analysis plan

1. Description of baseline characteristics of patients with asthmatic exacerbation, including history of exacerbation and treatment step at baseline (using GPC-established steps for asthma management in adults).2. Description of short-term (month after index exacerbation) and long term-patterns of pharmacotherapeutic management (treatment step in the 12 months after index exacerbation). 3. Description of intensity in the use of SABA as rescue medication in the 12 months after the date index.4. Description of the use of health resources, death and sick leaves in the year following the index exacerbation.5. Describe the incidence of asthma and of asthma exacerbations in the region. For the calculation of crude exacerbation rates, a Poisson regression model with adjustment for the estimated overdispersion parameter will be used.6. Analyse the association between baseline risk (history of exacerbation and step of treatment) using Cox models and represented by Kaplan-Meier graphs.