PATTERNS OF CLINICAL MANAGEMENT OF ASTHMATIC PATIENTS WITH EXACERBATIONS IN THE REAL-WORLD SETTING IN THE NATIONAL HEALTH SYSTEM

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28552
• EU PAS number:
  EUPAS28551
• Study ID:
  28552
• Official title and acronym:
  PATTERNS OF CLINICAL MANAGEMENT OF ASTHMATIC PATIENTS WITH EXACERBATIONS IN THE REAL-WORLD SETTING IN THE NATIONAL HEALTH SYSTEM
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Despite the availability of effective treatments, numerous studies (also in Spain) have shown a high prevalence of sub-optimal control of asthma that is associated with an increase of exacerbations which, when they are moderate to severe, entail significant use of expensive health care resources. The negative effects of inadequate control of asthma include increased risk of exacerbations, more emergency room visits and hospitalizations and higher mortality rate. In fact, patients with uncontrolled asthma have higher costs and lower quality of life than patients who are controlled.In our context, the evidence available in the real-world setting about how these patients are and how they are managed in the spanish National Health System is very scarce. There are few population-based studies, and in most cases, there are only small cohorts that may suffer from biases of representativeness and observation, which limits their extrapolation to all asthmatic patients with exacerbations. In the Valencian Community there is the ability to carry out studies in the real-world setting thanks to the availability of different population-based clinical and management information systems, that can be linked to individual patients through a unique identifier.The current project focuses on describing the characteristics of asthmatic patients with exacerbations, 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 exacerbations of the Valencian Community.
• Study status:
  Finalised

Research institutions and networks

Institutions

The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO)

Spain

Study timelines

Date when funding contract was signed

Planned: 10/12/2018

Actual: 10/12/2018

Study start date

Planned: 01/05/2019

Actual: 27/02/2019

Data analysis start date

Planned: 02/09/2019

Actual: 27/02/2019

Date of final study report

Planned: 31/12/2019

Actual: 27/02/2019

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

GSK, FISABIO

Study protocol

Initial protocol

20190211 01_1 ASTHMA_V1_0 PROTOCOL

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable