Study identification

PURI

https://redirect.ema.europa.eu/resource/47879

EU PAS number

EUPAS37065

Study ID

47879

Official title and acronym

An observational cohort study to describe intermittent OCS utilisation and its association with adverse outcomes and healthcare resource use and costs in asthma using the OPCRD and CPRD databases. (The burden of intermittent OCS use in asthma)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

Background/Rationale: Oral corticosteroids (OCS) are frequently prescribed for patients with respiratory conditions such as asthma. Despite evidence on the adverse outcomes of OCS, their use remains part of the clinical guidelines for asthma. There is evidence showing that relatively low cumulative doses of OCS can increase the risk of adverse outcomes and there is a wide consensus among physicians and researchers that the use of OCS should be limited to a minimum and should only be used when no other treatment option is available. Despite this OCS are still widely prescribed for patients with mild asthma. Whilst there is evidence showing increased risk of adverse events related to cumulative OCS dose there is little showing how patterns of intermittent OCS use are related to adverse events and related healthcare costs. Objectives: 1. To classify intermittent OCS prescriptions for patients with asthma and to describe longitudinal patterns of intermittent (acute) OCS use by Global Initiative for Asthma (GINA) step, and Inhaled Corticosteroids (ICS) and Short-Acting Beta-Agonists (SABA) use. 2. To assess the association between differing patterns of intermittent OCS use and OCS-related adverse events (AE) in patients with asthma 3. To describe the impact of different patterns of intermittent OCS use on the frequency of healthcare resource utilisation (HRU) in patients with asthma. 4. To describe the AE for patients with an average annual OCS dose of 250-499mg, 500-999mg, or =>1g of OCS during the follow up.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

David Price

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Astra Zeneca
Study protocol
Initial protocol

Intermittent OCS Protocol v6.3

English (1.06 MB - PDF)View document
Updated protocol

Intermittent OCS Protocol v6.5 JC 20220128

English (1.03 MB - 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