Status: Ongoing First registered on: 19/11/2021
Last updated on: 19/11/2021
1. Study identification
EU PAS Register NumberEUPAS39039
Official titleCharacTeristics 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
Study title acronymTAILOR
Study typeObservational study
Brief description of the studyIn 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
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsHealth Data Science
Department/Research groupDepartment of Medical Informatics - Health Data Science
Organisation/affiliationErasmusMC
Website/Homepagehttps://www.healthdatascience.nl/contact
Details of (Primary) lead investigator
Title Dr
Last name Verhamme
First name Katia
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

Aarhus University Dept. of Clinical Epidemiology
NDORMS, Oxford - UK
SIMG, Florence - Italy
Countries in which this study is being conducted
International study

Denmark
Italy
Netherlands
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/12/2020
Start date of data collection01/01/2021
Start date of data analysis01/03/2021
Date of interim report, if expected17/05/202107/06/2021
Date of final study report15/06/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesChiesi100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Verhamme
First name Katia
Address line 1Dr. Molewaterplein 40
Address line 2 
Address line 3 
CityRotterdam 
Postcode3015 GD 
CountryNetherlands
Phone number (incl. country code)31107044129 
Alternative phone number 
Fax number (incl. country code) 
Email address k.verhamme@erasmusmc.nl
Public Enquiries
Title Dr 
Last name Verhamme 
First name Katia 
Address line 1Dr. Molewaterplein 40 
Address line 2 
Address line 3 
CityRotterdam 
Postcode3015 GD 
CountryNetherlands 
Phone number (incl. country code)31107044129 
Alternative phone number 
Fax number (incl. country code) 
Email address k.verhamme@erasmusmc.nl 
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