Clinical trial NCT02913872: Childhood Asthma Management in Primary Care: Implementation Of Exhaled Nitric Oxide and Spirometry Testing
Official title: Childhood Asthma Management in Primary Care: Implementation Of Exhaled Nitric Oxide and Spirometry Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Spirometry
Exhaled Nitric Oxide
Primary Care
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: Aerocrine AB
First posted: 2016-09-26
Enrollment: 613
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients registered to participating general practices in Leicestershire and Northamptonshire

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice
timeFrame: 12 months
measure: Number of Children in Whom Usable Spirometry and eNO Data Can be Obtained
timeFrame: 12 months
Secondary outcomes:
measure: The Number of Children in Whom a Diagnosis of Asthma Can be Confirmed Using Spirometry and eNO Testing
timeFrame: 12 months
measure: Change in Paediatric Asthma Quality of Life Questionnaire Score Measured at Enrolment and 3-6 Months Post-enrollment
timeFrame: PAQLQ score was assessed at enrolment and then again at 3-6 months post enrolment
measure: Change in Child Health Utility 9D Questionnaire Score Measured at Enrolment and at 3-6 Months Post-enrolment
timeFrame: CHU9D score was assessed at enrolment and then again at 3-6 months post-enrolment.
Other outcomes:
measure: The Number of Primary Care Staff Who Found Providing Spirometry and eNO Testing for Children Acceptable After Being Trained
timeFrame: 12 months
measure: The Number of Participants Who Found Spirometry and eNO Testing Acceptable
timeFrame: 12 months
Locations:
city: Leicester
country: United Kingdom
facility: Countesthorpe Health Centre
state: Leicestershire
city: Corby
country: United Kingdom
facility: Lakeside Surgery
state: Northamptonshire
Study officials:
affiliation: National Institute for Health Research, Leicester Respiratory Biomedical Research Unit, University of Leicester
name: Erol Gaillard, PhD MRCPCH
role: PRINCIPAL_INVESTIGATOR
References: