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

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 Overview

• Status: Completed
• Conditions: Asthma

• Study Type: Observational
• Enrollment (Actual): 612

Contacts and Locations

Study Locations

• United Kingdom
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE8 5QJ
      • Countesthorpe Health Centre
  • Northamptonshire
    • Corby, Northamptonshire, United Kingdom, NN17 2UR
      • Lakeside Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients registered to participating general practices in Leicestershire and Northamptonshire

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of children in whom a diagnosis of asthma can be confirmed using spirometry and eNO testing		12 months
The number of asthma misdiagnoses in children identified using spirometry and eNO testing		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)	To facilitate a health economics analysis on the impact of using spirometry and eNO for the management of paediatric asthma in general practice	12 months
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)	To facilitate a health economics analysis on the impact of using spirometry and eNO for the management of paediatric asthma in general practice	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of primary care staff who found providing spirometry and eNO testing for children acceptable after being trained	Based on responses to a questionnaire administered at the end of their training using pre-determined responses along a 5-point likert scale.	12 months
The number of participants who found spirometry and eNO testing acceptable	Based on responses to a questionnaire administered at the end of their asthma review using pre-determined responses along a 5-point likert scale.	12 months

Collaborators and Investigators

• Sponsor: University of Leicester
• Collaborators: Aerocrine AB
• Investigators: Principal Investigator: Erol Gaillard, PhD MRCPCH, National Institute for Health Research, Leicester Respiratory Biomedical Research Unit, University of Leicester

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimate): September 26, 2016

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Primary Care; Spirometry; Exhaled Nitric Oxide
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 0566