Study identification

PURI

https://redirect.ema.europa.eu/resource/31771

EU PAS number

EUPAS12330

Study ID

31771

Official title and acronym

An observational evaluation of prescribing of fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist (ICS/LABA): fluticasone propionate / formoterol (FP/FOR) and adverse events in routine primary care at 18-months and 36-months post launch

DARWIN EU® study

No

Study countries

United Kingdom

Study description

This study aims to evaluate adverse events, prescribing prevalence and patient characteristics for patients initiating on FP/FOR or other FDC ICS/LABA therapies prescribed in the 18 and 36 months post launch of FP/FOR in the UK. It will be a historical cohort study within which four subgroups will be evaluated (adult patients (≥ 12 years) with asthma, patients with COPD (and no asthma), paediatric asthma patients 4–11 years, patients prescribed ICS/LABA as the “MART” regimen). Patients included have ≥1 prescriptions for any ICS/LABA fixed-dose combination from 2012. The number and percentage of patients prescribed FP/FOR and other FDC ICS/LABAs and the frequency and percentage of adverse events and patient characteristics including demographic characteristics, comorbidities, medication and disease-severity measures will be evaluated for patients prescribed FP/FOR and other FDC ICS/LABA therapies, and for each of the subgroups.

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:

Date of final study report

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

More details on funding

Mundipharma Research Ltd
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 1 (imposed as condition of marketing authorisation)