Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000560

EU PAS number

EUPAS1000000560

Study ID

1000000560

Official title and acronym

FLAIR: Fostair vs Symbicort: CLinical effectiveness of anti-inflammatory reliever therapies (AIR): a non-inferiority study

DARWIN EU® study

No

Study countries

United Kingdom

Study description

A non-inferiority study using a retrospective cohort design to compare people taking Fostair and Symbicort as anti-inflammatory reliever therapy (AIR). The study will use the Optimum Patient Care Research Database (OPCRD) to identify adults (18+ years) with a diagnosis of asthma and no other additional chronic respiratory condition who initiated Fostair or Symbicort as AIR for the first time from July 2012 (i.e. when Fostair was first introduced). Index date will be the date of initiating Fostair or Symbicort with at least 12 months registration at the relevant GP surgery. Follow-up will be up to 3 years, allowing exposure time to vary as people exit the cohort (transferring out of GP practice or death).
Individuals will be propensity score weighted such that the chosen characteristics of the individuals are the same in each of the treatment groups.
The primary outcome is non-inferiority of severe exacerbation rates in the 2 years following treatment initiation, as defined as inferiority of no more than 20% at the 2.5% (one-sided probability) level.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

David Price

Primary lead investigator
ORCID number:
0000-0002-9728-9992
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Chiesi UK, OPRI UK
Study protocol
Initial protocol

FLAIR Study Protocol_V3.0_28042025.pdf

English (1.45 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable