Studying 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 (Assessing RIsk of exAcerbation (ARIA))

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26465
• EU PAS number:
  EUPAS16891
• Study ID:
  26465
• Official title and acronym:
  Studying 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 (Assessing RIsk of exAcerbation (ARIA))
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  5-10% 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Networks

Optimum Patient Care (OPC) Network

United Kingdom (Northern Ireland)

Study timelines

Date when funding contract was signed

Planned: 13/12/2016

Actual: 13/12/2016

Study start date

Planned: 20/12/2016

Actual: 20/12/2016

Data analysis start date

Planned: 27/12/2016

Actual: 27/12/2016

Date of final study report

Planned: 13/08/2017

Actual: 22/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

121216 FeNO and Eosinophils in ICS-Treated Asthma_v1.3

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable