Skip to main content
OpenTrials
Completed

NCT Number: NCT02913872

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Countesthorpe Health Centre, Leicester, Leicestershire, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 12 months

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

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

    Time frame: 12 months

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

Secondary outcomes

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

    Time frame: 12 months

    Number of children in whom an asthma diagnosis could be confirmed on objective testing

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

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

    Timepoints - Assessed at enrolment and at 3-6 months post enrolment Purpose: The Paediatric Asthma Quality of Life Questionnaire (PAQLQ) was developed to measure the functional problems (physical, emotional and social) that are most troublesome to children with asthma.

    Format: The PAQLQ can be administered by an interviewer or self-administered by the child Content: The PAQLQ contains 23 questions that cover three domains: activity limitation, symptoms, and emotional function Scoring: Children are asked to think about how they have been during the previous week and to respond to each of the 32 questions on a 7-point scale (7 = not bothered at all -

    1 = extremely bothered). The overall PAQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains. A change in score greater than 0.5 on the 7-point scale can be considered clinically important.

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

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

    Timepoints - measured at enrolment and at 3-6 months post-enrolment Purpose: The CHU9D is a paediatric generic preference based measure of health related quality of life. It consists of a descriptive system and a set of preference weights, giving utility values for each health state described by the descriptive system, allowing the calculation of quality adjusted life years (QALYs) for use in cost utility analysis.

    Format: Consists of nine dimensions of health-related quality of life, including worry, sadness, pain, tiredness, annoyance, school, sleep, daily routine, and activities. The child completes the questionnaire, or a proxy can complete it for younger children Scoring: Scores can range from -0.1059 (min) to 1 (max); with a score of 1 indicating a "state of perfect health", and a lower score indicating worse health. A minimally important difference (MID) of 0.03 is used to assess the magnitude of mean difference when comparing CHU9D scores.

Other outcomes

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

    Time frame: 12 months

    Based on responses to a questionnaire administered at the end of their training using pre-determined responses along a 5-point likert scale.

  2. The Number of Participants Who Found Spirometry and eNO Testing Acceptable

    Time frame: 12 months

    Based on responses to a questionnaire administered at the end of their asthma review using pre-determined responses along a 5-point likert scale.

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • Aerocrine AB

Registry information

Acronym: CHAMPIONS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2016
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.