Exhaled Nitric Oxide in Asthma Management

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: January 2015

Interventions

  • Device: eNO monitoring
    • Patient undergoing review with eNO monitored using either NIOX MINO® and NIOX Flex®

Arms, Groups and Cohorts

  • eNO monitoring
    • Patients undergoing eNO monitoring at the index prescription date
  • No eNO monitoring

Clinical Trial Outcome Measures

Primary Measures

  • Severe Exacerbation Rate
    • Time Frame: One Year Outcome Period
    • Where exacerbations are defined as an occurrence of: Unscheduled hospital admissions / Emergency Room attendance for asthma, OR Use of acute courses of oral steroids
  • Proxy Asthma Control
    • Time Frame: One year outcome period
    • 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.

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Aged: 6-80 years 2. Evidence of active asthma (diagnostic code and/or ≥6 prescriptions for asthma therapy at any time in their records) 3. Evidence of current asthma treatment (≥2 asthma prescriptions during baseline year and outcome year) 4. 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:

1. Had a COPD read code at any time; and/or 2. Had any chronic respiratory disease, except asthma, at any time; and/or 3. Patients on maintenance oral steroids during baseline year 4. Smoker or ex-smoker aged over 60

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Research in Real-Life Ltd
  • Collaborator
    • Aerocrine AB
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Price, Prof., MD, David Price – Research in Real-Life Ltd

References

Clancy RM, Amin AR, Abramson SB. The role of nitric oxide in inflammation and immunity. Arthritis Rheum. 1998 Jul;41(7):1141-51. doi: 10.1002/1529-0131(199807)41:73.0.CO;2-S. No abstract available.

Baraldi E, Carra S, Dario C, Azzolin N, Ongaro R, Marcer G, Zacchello F. Effect of natural grass pollen exposure on exhaled nitric oxide in asthmatic children. Am J Respir Crit Care Med. 1999 Jan;159(1):262-6. doi: 10.1164/ajrccm.159.1.9804063.

Piacentini GL, Bodini A, Costella S, Vicentini L, Peroni D, Zanolla L, Boner AL. Allergen avoidance is associated with a fall in exhaled nitric oxide in asthmatic children. J Allergy Clin Immunol. 1999 Dec;104(6):1323-4. doi: 10.1016/s0091-6749(99)70031-x. No abstract available.

Bukstein D, Luskin AT, Brooks EA. Exhaled nitric oxide as a tool in managing and monitoring difficult-to-treat asthma. Allergy Asthma Proc. 2011 May-Jun;32(3):185-92. doi: 10.2500/aap.2011.32.3449. Epub 2011 Apr 8.

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