Study identification

PURI

https://redirect.ema.europa.eu/resource/39040

EU PAS number

EUPAS39039

Study ID

39040

Official title and acronym

CharacTeristics of treAtment response to hIgh dose ICS/LABA vs. Medium or high dOse ICS/LABA + LAMA in patients with uncontRolled moderate to severe asthma on medium dose ICS/LABA - TAILOR study

DARWIN EU® study

No

Study countries

Denmark
Italy
Netherlands
United Kingdom

Study description

In patients with uncontrolled moderate to severe asthma (i.e. GINA step 4), GINA recommends to either increase the dose of ICS to high dose ICS+LABA or to add a LAMA (tiotropium) on top of medium dose ICS+LABA. Although not recommended by GINA, it is likely that – in real life – there are also patients who get stepped-up to high dose ICS+LABA+LAMA. As of today, which patients respond best to which treatment option – in real life - is yet unknown. For this reason, we will conduct a retrospective cohort study, in patients with uncontrolled moderate to severe asthma (step 4) initiating one of the treatment options of GINA treatment step-up. Our study period is from 2010-2020 and we will use data from 4 databases from 4 European countries: the Netherlands (IPCI), Denmark (Aarhus), Italy (HSD) and UK (CPRD). The study population will consist of all patients with asthma, aged 18-65 years with at least 1 year of database history and active follow-up during the study. Within this cohort, patients with treatment step up from GINA step 4 (medium dose ICS/LABA) will be selected. The main objectives are as following: • Identify the main drivers of prescribing any of the three step-up treatment options • Identify patient features/characteristics associated with response to the specific treatment regimens In addition, we have the following secondary objectives: • To investigate differences in Health Care Resources utilisation in the year prior vs. year after treatment step-up (high dose ICS+LABA, medium dose ICS+LABA+LAMA, high dose ICS+LABA+LAMA) • To investigate differences in rescue medication use (SABA) and OCS use in the year prior vs year after treatment step-up • To study differences in treatment characteristics (proportion of patients discontinuing treatment, switching (i.e. treatment step down)) after initiation of one of the 3 treatment options • To research the types of LAMAs being used

Study status

Ongoing
Research institutions and networks

Institutions

NDORMS Oxford - UK, SIMG Florence - Italy

Contact details

Katia Verhamme

Primary lead investigator
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:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Chiesi
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable