Disease trajectory and treatment escalation in severe asthma: A retrospective analysis of data from the Optimum Patient Care Research Database (OPCRD)

Study identification

• EU PAS number:
  EUPAS1000000292
• Study ID:
  1000000292
• Official title and acronym:
  Disease trajectory and treatment escalation in severe asthma: A retrospective analysis of data from the Optimum Patient Care Research Database (OPCRD)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Asthma effects over 300 million globally with 5-10% estimated to have severe disease. Many patients achieve disease control on inhaled medications and are managed within primary care, however, a small number prove challenging to treat and are often exposed to high dose oral corticosteroid (OCS) therapies which can lead to significant co-morbidities developing. Current asthma guidelines advocate a stepwise approach to increasing treatment based on symptoms and exacerbations; however, treatment is often escalated despite symptoms not being related to asthma. ; ; At present, it is unclear if extra-pulmonary factors directly influence treatment escalation in severe asthma or are simply a consequence of treatment i.e., reverse causation. Further work is needed to examine the temporal relationship between extra-pulmonary comorbidities and treatment escalation in patients with severe disease. ; ; This is an observational, retrospective, UK-wide analysis comprising of two nested case-control studies set within with the OPCRD. ; ; The specific aims of this study are to:; 1) To explore factors associated with treatment escalation from mild to moderate treatment to high dose treatments (Global initiative for asthma [GINA]: step 2/3 to step 4/5).; 2) To investigate factors associated with treatment escalation in patients with severe asthma (GINA step 4 to GINA step 5).; 3) To assess the temporal relationship between key extra-pulmonary factors and treatment escalation.; 4) To explore the relationship between blood eosinophil count and treatment escalation.
• Study status:
  Planned

Research institutions and networks

Institutions

Queen's University Belfast

Study timelines

Date when funding contract was signed

Planned:31/05/2023

Actual:31/05/2023

Study start date

Planned:01/08/2024

Data analysis start date

Planned:07/08/2024

Date of final study report

Planned:30/09/2024

Sources of funding

Other

More details on funding

Health data research UK (HDR UK)

Regulatory

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