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

Asthma Clinical Trial

— CHAMPIONS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913872
• Other study ID #: 0566
• Status: Completed
• Start date: June 2016
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 612
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United Kingdom	Lakeside Surgery	Corby	Northamptonshire
United Kingdom	Countesthorpe Health Centre	Leicester	Leicestershire

Sponsors (2)

Lead Sponsor	Collaborator
University of Leicester	Aerocrine AB

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Length of training required for general practices to be able to independently perform/interpret spirometry and eNO in children		12 months
Primary	Time needed to perform paediatric spirometry and eNO testing in general practice		12 months
Primary	Number of children in whom usable spirometry and eNO data can be obtained		12 months
Secondary	The number of children in whom a diagnosis of asthma can be confirmed using spirometry and eNO testing		12 months
Secondary	The number of asthma misdiagnoses in children identified using spirometry and eNO testing		12 months
Secondary	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
Secondary	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