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

NCT02913872 | Completed Results

• 1 other identifier: 0566
• Study Type: observational
• Target: 613
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Keywords

Spirometry; Exhaled Nitric Oxide; Primary Care

Outcome Measures

Primary Outcomes (2)

• Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice

  Time (minutes) to perform both spirometry and eNO test in children

  12 months

• Number of Children in Whom Usable Spirometry and eNO Data Can be Obtained

  Number of children (out of 612) able to perform objective tests

  12 months

Secondary Outcomes (3)

• The Number of Children in Whom a Diagnosis of Asthma Can be Confirmed Using Spirometry and eNO Testing

  12 months

• Change in Paediatric Asthma Quality of Life Questionnaire Score Measured at Enrolment and 3-6 Months Post-enrollment

  PAQLQ score was assessed at enrolment and then again at 3-6 months post enrolment

• Change in Child Health Utility 9D Questionnaire Score Measured at Enrolment and at 3-6 Months Post-enrolment

  CHU9D score was assessed at enrolment and then again at 3-6 months post-enrolment.

Other Outcomes (2)

• The Number of Primary Care Staff Who Found Providing Spirometry and eNO Testing for Children Acceptable After Being Trained

  12 months

• The Number of Participants Who Found Spirometry and eNO Testing Acceptable

  12 months

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients registered to participating general practices in Leicestershire and Northamptonshire

You may qualify if:

• On the practice asthma register or
• 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
• Have been prescribed ≥ 2 Salbutamol MDI's in the last 12 months or
• Had a documented exacerbation of asthma in the last 12 months
• Able and willing, in the opinion of the Investigator, to give informed consent

You may not qualify if:

• Children who are unable to perform lung function tests for any reason
• Children and young people \<5 years and \>16 years
• Unable or unwilling, in the opinion of the Investigator, to give informed consent

Sponsors & Collaborators

• University of Leicester: lead
• Aerocrine AB: collaborator

Study Sites (2)

Countesthorpe Health Centre

Leicester, Leicestershire, LE8 5QJ, United Kingdom

Location

Lakeside Surgery

Corby, Northamptonshire, NN17 2UR, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr Erol Gaillard
• Organization: University of Leicester

eag15@le.ac.uk

+44116 252 3261

Study Officials

• Erol Gaillard, PhD MRCPCH

  National Institute for Health Research, Leicester Respiratory Biomedical Research Unit, University of Leicester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 26, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Locations

GB (2)