Status: Ongoing First registered on: 09/08/2018
Last updated on: 09/08/2018
1. Study identification
EU PAS Register NumberEUPAS25203
Official titleAsthma and Type 2 Comorbidities - Real-life Characterisation of Patients with Active Asthma and Type 2 Asthma Comorbidities
Study title acronym
Study typeObservational study
Brief description of the studyAsthma is a common long-term condition which is responsible for considerable morbidity, mortality and costs. There are several related conditions, involving type 2 inflammation which have been identified as affecting asthma outcomes. The nine T2 co-morbidities of interest are: eczema, allergic rhinitis, chronic rhinosinusitis, nasal polyps, urticaria, allergic conjunctivitis, food allergy, eosinophilic oesophagitis and anaphylaxis. Because of the common underlying disease process, it has been suggested that successful treatment of one might also improve related conditions. The frequency with which these conditions co-occur in patients with asthma has not yet been described, nor has the relationship between co-morbidity patterns with asthma severity and asthma-related resource utilisation. The aim of this study is to describe the frequency and interrelations of these conditions, and assess associations with asthma severity, asthma-related healthcare resource utilisation and costs, within a real-world asthma population. The prevalence of each co-morbidities pattern will be measured, and associations between co-morbidities described using likelihood ratios and principal component analysis. This will be used to select a subset of patterns, in which patient characteristics, asthma severity, healthcare resource utilisation and cost will be compared using multivariable regression models, in all patients and stratified by asthma severity, co-morbidity severity and activity, blood eosinophil count and age.
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 belongsOPRI Pte Ltd
Department/Research groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
Website/Homepagewww.opri.sg
Details of (Primary) lead investigator
Title Professor
Last name Price
First name David
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/02/2018
Start date of data collection01/03/201801/03/2018
Start date of data analysis05/03/201805/03/2018
Date of interim report, if expected29/06/201822/06/2018
Date of final study report24/11/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesRegeneron, Sanofi100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington 
Address line 3 
CityCambridge 
Postcode 
CountryUnited Kingdom
Phone number (incl. country code)44-1223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.org
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 15a Coles Lane 
Address line 2Oakington 
Address line 3 
CityCambridge 
Postcode 
CountryUnited Kingdom 
Phone number (incl. country code)44-1223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.org 
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