Status: Finalised First registered on: 20/12/2016
Last updated on: 07/11/2018
1. Study identification
EU PAS Register NumberEUPAS16891
Official titleStudying the value of fractional exhaled Nitric Oxide and blood eosinophils as biomarkers in predicting which patients will suffer from more frequent asthma exacerbations, and evaluating the subsequent healthcare resource utilisation
Study title acronymAssessing RIsk of exAcerbation (ARIA)
Study typeObservational study
Brief description of the study5-10% of all patients presenting with asthma, have severe asthma that is refractory to standard inhaled corticosteroid (ICS) treatment. The number of blood eosinophils has been shown to be positively correlated with the frequency of severe asthma exacerbations, and is a promising marker for responsiveness to monoclonal antibody therapy in the presence of corticosteroid resistance. FeNO is another biomarker for corticosteroid responsiveness. FeNO levels and blood eosinophilia together, may predict patients with uncontrolled corticosteroid-resistant asthma who may respond positively to monoclonal antibody therapy. The study aims to correlate the level of FeNO and blood eosinophils to the number of severe exacerbations. The prospective burden of disease, healthcare resource utilisation costs, quality of life, and stability of biomarkers over time and changes in ICS dosage for patients with different categories of FeNO and blood eosinophils will also be assessed to understand their implications in severe asthma. Phase 1 and 2 primary objectives compare the rate ratio of severe exacerbations in patient groups categorised by different biomarker levels before and after FeNO measurement. Phase 3 assesses quality of life data across matched and different patient groups while phase 4 studies consistency between initial FeNo and Eosinophil levels to those taken at specialist clinics. A bespoke dataset(OPCRD) of FeNO and blood eosinophil measurements from asthmatic patients in the UK is used. 850 patients between the 6 groups for phase 1 and 2 are required. Matched analysis will take place between 2 groups of groups of interest identified analysis. Primary analysis will be carried with numbers of exacerbations collected and then compared across matched groups.Results will be presented additionally as a rate ratio between comparison groups.
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?
Yes

Optimum Patient Care (OPC)
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 signed13/12/201613/12/2016
Start date of data collection20/12/201620/12/2016
Start date of data analysis27/12/201627/12/2016
Date of interim report, if expected
Date of final study report13/08/201722/06/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
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 
PostcodeCB24 3BA 
CountryUnited Kingdom
Phone number (incl. country code)4401223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 15a Coles Lane 
Address line 2Oakington 
Address line 3 
CityCambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom 
Phone number (incl. country code)4401223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg 
Top