Childhood Asthma Management in Primary Care: Implementation Of Exhaled Nitric Oxide and Spirometry Testing

Overview

What are the capacity and training needs in general practice to implement routine spirometry and eNO testing in children aged 5-16 years?

Asthma is the commonest long-term disease of childhood in the United Kingdom (UK). Under-diagnosis and under-treatment of childhood asthma in general practice (GP) have been reported from several European countries including the UK. This can result in poor symptom control and increased risk of asthma related deaths.

It has been suggested that both under- and over- diagnosis of childhood asthma in general practice could be improved by routinely using objective lung function testing for diagnosis and monitoring.

The proposed objective lung function tests (spirometry and exhaled nitric oxide measurements – eNO) are already used routinely in UK hospitals, but are not usually available in general practice where most children are cared for.

Why is it important? – Availability of these tests will help health professionals in general practice to look after children with asthma better, and hopefully improve asthma control.

What will this study achieve? – Though it is believed that providing spirometry and eNO in general practice would be beneficial, there is little data on how this can be achieved. This study will employ both qualitative and quantitative measures in order to evaluate the resources required to implement routine spirometry and eNO testing for children in primary care; and to investigate the impact this would have on diagnosis in children with suspected asthma.

How? – The investigators will work with general practices in and around Leicestershire, UK. Firstly, to identify what the barriers are to implementing these tests, and secondly to train the practices to perform and interpret spirometry and eNO independently in children.

Children with suspected or previously diagnosed asthma will be invited for review and lung function testing. The investigators will record the time it takes to train general practices to perform and interpret spirometry and eNO independently, and the additional clinic capacity required to provide these tests.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2017

Clinical Trial Outcome Measures

Primary Measures

  • Length of training required for general practices to be able to independently perform/interpret spirometry and eNO in children
    • Time Frame: 12 months
  • Time needed to perform paediatric spirometry and eNO testing in general practice
    • Time Frame: 12 months
  • Number of children in whom usable spirometry and eNO data can be obtained
    • Time Frame: 12 months

Secondary Measures

  • The number of children in whom a diagnosis of asthma can be confirmed using spirometry and eNO testing
    • Time Frame: 12 months
  • The number of asthma misdiagnoses in children identified using spirometry and eNO testing
    • Time Frame: 12 months
  • The change in paediatric asthma quality of life questionnaire score from point of enrolment (when initial asthma review takes place) to follow up (by repeat postal questionnaire sent at 3-6 months)
    • Time Frame: 12 months
    • To facilitate a health economics analysis on the impact of using spirometry and eNO for the management of paediatric asthma in general practice
  • The change in Child Health Utility 9D Questionnaire score from point of enrolment (when initial asthma review takes place) to follow up (by repeat postal questionnaire sent at 3-6 months)
    • Time Frame: 12 months
    • To facilitate a health economics analysis on the impact of using spirometry and eNO for the management of paediatric asthma in general practice

Participating in This Clinical Trial

Inclusion Criteria

1. On the practice asthma register or

2. Are prescribed regular (on repeat prescription) inhaled corticosteroids including beclometasone, fluticasone and budesonide and also search specifically for 'brands' that are commonly prescribed to include 'clenil', 'seretide', 'symbicort', and 'qvar' or

3. Have been prescribed ≥ 2 Salbutamol MDI's in the last 12 months or

4. Had a documented exacerbation of asthma in the last 12 months

5. Able and willing, in the opinion of the Investigator, to give informed consent

Exclusion Criteria

1. Children who are unable to perform lung function tests for any reason

2. Children and young people <5 years and >16 years

3. Unable or unwilling, in the opinion of the Investigator, to give informed consent

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Leicester
  • Collaborator
    • Aerocrine AB
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Erol Gaillard, PhD MRCPCH, Principal Investigator, National Institute for Health Research, Leicester Respiratory Biomedical Research Unit, University of Leicester

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