Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000377

EU PAS number

EUPAS1000000377

Study ID

1000000377

Official title and acronym

COMParative clinical effectiveness of FostAIR (extrafine beclomethasone/formoterol) as maintenance and reliever therapies in adult patients with asthma (CompAIR)

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 maintenance and reliever therapy (MART). 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 MART 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. 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 12 months following treatment initiation, as defined as inferiority of no more than 10% 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

Actual:

Study start date

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
Study protocol
Initial protocol

Protocol_CompAIR_v2.2_20241119.pdf

English (935.18 KB - 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