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 type

• Study topic:
  Disease /health condition

  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Medication use Characterisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  Patients with asthma and who were registered at a general practice which provides data to Optimum Patient Care (OPC).; Patients with following criteria were included:; 1. A diagnostic Read code for asthma (ever, without an asthma resolution Read code at the index date) qualifying for inclusion in the register of patients with asthma, maintained by GPs for the Quality Outcomes Framework (QOF) OR prescription of ≥2 asthma related medications, one of which must be an ICS, none of which are a LAMA, and without a FEV1/FVC<0.70; 2. A FeNO reading in the last 2 years prior to the extraction date that serves as the index date; 3. ≥ 1 prescription for ICS in the year prior to the most recent FeNO reading; 4. Age 18-80 inclusive at the date of the most recent FeNO reading; 5. ≥ 1 valid blood eosinophil count measurement within 2 years prior to the index date; 6. Continuous data prior to index date for one year; 7. Completion of relevant QoL questionnaire (phase 3); 8. Attendance and completion of asthma review clinic (phase 4)
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma patients
• Estimated number of subjects:
  850

Study design details

• Main study objective:
  The aim of the study is to correlate the level of FeNO and blood eosinophils to the number of severe exacerbations. Assessment of both biomarkers together may provide a novel method to identify patients at higher risk of exacerbations and may benefit from monoclonal antibody treatment.
• Outcomes:
  Phase 1 primary objective:To find the rate ratio of severe exacerbations in patients categorised by different biomarker levels in the year prior to the FeNO measurement. Phase 1 secondary objective:To describe demographic characteristics, lung function, comorbidities, respiratory medication and healthcare resource utilisation in patients categorised by biomarkers.
• Data analysis plan:
  A characterisation of all baseline demographic, co-morbidity, indicators of disease severity and other patient characteristic variables will be carried out and presented for each arm. Potential confounders are identified based on a combination of baseline imbalance, bias potential and expert judgement, and the most relevant confounders will be used for direct matching.The primary analysis will be carried out in accordance after matching, and will require the numbers of exacerbations to be collected and then compared through matched groups, with the exact matching method based on baseline characteristics collected through the secondary analysis. Results will be presented additionally as a rate ratio between comparison groups.Secondary Analysis,descriptive statistics will be carried out in accordance with the general methods. Characteristics of cohorts will be compared using the chi-squared test and the Kruskal Wallis test, as appropriate for unmatched groups.

Documents

Study report

2017_06_22_AUREA_final_report_1.2FIN