Exhaled Nitric Oxide in Asthma Management

Study Overview
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Brief Summary
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This study will compare the absolute and relative effectiveness of managing real-life asthma with and without the use of NIOX MINO® and NIOX Flex® to measure exhaled nitric oxide (eNO) as a marker of underlying airway inflammation to guide appropriate management. As exhaled nitric oxide responds rapidly to environmental changes and can act as a marker of underlying inflammation it is proposed that incorporating eNO monitoring into routine asthma management treatment allows strategies to be more accurately tailored to the patients needs, increasing the probability of good asthma control.

Official Title
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Exhaled Nitric Oxide in Asthma Management: a Retrospective Real-life Observational Evaluation of the Use of Exhaled Nitric Oxide Measurements for Asthma Management in a UK Primary Care Population

Conditions
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Asthma

Intervention / Treatment
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* Device: eNO monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged: 6-80 years Evidence of active asthma (diagnostic code and/or ≥6 prescriptions for asthma therapy at any time in their records) Evidence of current asthma treatment (≥2 asthma prescriptions during baseline year and outcome year) Have at least one year of up-to-standard (UTS) baseline data and at least one year of UTS outcome data (following the IPD) Exclusion Criteria: Had a COPD read code at any time; and/or Had any chronic respiratory disease, except asthma, at any time; and/or Patients on maintenance oral steroids during baseline year Smoker or ex-smoker aged over 60

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| eNO monitoring<br>Patients undergoing eNO monitoring at the index prescription date | Device: eNO monitoring<br>* Patient undergoing review with eNO monitored using either NIOX MINO® and NIOX Flex®<br>|
| No eNO monitoring<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe Exacerbation Rate | Where exacerbations are defined as an occurrence of: Unscheduled hospital admissions / Emergency Room attendance for asthma, OR Use of acute courses of oral steroids | One Year Outcome Period | 
| Proxy Asthma Control | No recorded hospital attendance for asthma, including admission, Emergency Room (ER) attendance or Out-Patient Department (OPD) attendance, AND No prescriptions for acute courses of oral steroids, AND No GP consultations, hospital admissions or ER attendance for lower respiratory tract infections (LRTI) requiring antibiotics. | One year outcome period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control (including SABA) | Proxy asthma control (defined above), including the absence of average daily prescribed dose of ≤200mcg salubtamol / ≤500mcg terbutaline | One year outcome | 
| Respiratory-related hospitalisations and referrals | Mean number of respiratory-related hospitalisations and referrals per patient during the outcome year | One year outcome period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Real-world, observational, Nitric oxide, Inhaled corticosteroid, UK