Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000292

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

Contact details

Liam Heaney

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Health data research UK (HDR UK)
Study protocol
Initial protocol

OPCRD protocol submission encepp.pdf

English (331.89 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable