Trial Outcomes & Findings for Childhood Asthma Management in Primary Care: Implementation Of Exhaled Nitric Oxide and Spirometry Testing (NCT NCT02913872)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

613 participants

Primary outcome timeframe

12 months

Results posted on

2025-02-03

Participant Flow

Primary care practices based in the the East Midlands, England. Recruitment between June 2016 and August 2017

N/A - single group observational study only

Participant milestones

Participant milestones
Measure	Study Cohort Participating practices Ten practices participated in this study. They served a population of almost 120,000 people, ranging from \~3500 to 48000 registered patients. Geographically, five of the practices were located in inner-city Leicester, three were in surrounding towns, and two were in village locations. Participants Electronic database searches identified 1548 eligible children; 1097 (71%) were on their GPs asthma register, and 451 (29%) were not, but had received asthma medications in the previous 12 months. In total 614 children responded to the written invitations and attended clinics held between June 2016 and August 2017; of these, 456 (75%) were on the asthma register. Sixty-three percent of children were recruited in the months of March to August, and the remainder in the months of September to February. Written informed consent was obtained from carers of 613 children. One parent refused consent and one parent later withdrew their consent without giving a reason, leaving 612 children in total. The characteristics of recruited children are shown in table 1. Overall, the participation rate was 40% of eligible patients, but ranged from 8% to 59% between practices. The practice recruiting only 8% of eligible children was an outlier, and due in part to recruitment at this practice commencing late into the study and therefore fewer clinics (in relation to the practice size) were set up compared with other practices.
Overall Study STARTED	613
Overall Study COMPLETED	612
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Cohort Participating practices Ten practices participated in this study. They served a population of almost 120,000 people, ranging from \~3500 to 48000 registered patients. Geographically, five of the practices were located in inner-city Leicester, three were in surrounding towns, and two were in village locations. Participants Electronic database searches identified 1548 eligible children; 1097 (71%) were on their GPs asthma register, and 451 (29%) were not, but had received asthma medications in the previous 12 months. In total 614 children responded to the written invitations and attended clinics held between June 2016 and August 2017; of these, 456 (75%) were on the asthma register. Sixty-three percent of children were recruited in the months of March to August, and the remainder in the months of September to February. Written informed consent was obtained from carers of 613 children. One parent refused consent and one parent later withdrew their consent without giving a reason, leaving 612 children in total. The characteristics of recruited children are shown in table 1. Overall, the participation rate was 40% of eligible patients, but ranged from 8% to 59% between practices. The practice recruiting only 8% of eligible children was an outlier, and due in part to recruitment at this practice commencing late into the study and therefore fewer clinics (in relation to the practice size) were set up compared with other practices.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Cohort n=612 Participants Participating practices Ten practices participated in this study. They served a population of almost 120,000 people, ranging from \~3500 to 48000 registered patients. Geographically, five of the practices were located in inner-city Leicester, three were in surrounding towns, and two were in village locations. Participants Electronic database searches identified 1548 eligible children; 1097 (71%) were on their GPs asthma register, and 451 (29%) were not, but had received asthma medications in the previous 12 months. In total 614 children responded to the written invitations and attended clinics held between June 2016 and August 2017; of these, 456 (75%) were on the asthma register. Sixty-three percent of children were recruited in the months of March to August, and the remainder in the months of September to February. Written informed consent was obtained from carers of 613 children. One parent refused consent and one parent later withdrew their consent without giving a reason, leaving 612 children in total. The characteristics of recruited children are shown in table 1. Overall, the participation rate was 40% of eligible patients, but ranged from 8% to 59% between practices. The practice recruiting only 8% of eligible children was an outlier, and due in part to recruitment at this practice commencing late into the study and therefore fewer clinics (in relation to the practice size) were set up compared with other practices.
Age, Continuous	10.0 Years STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	280 Participants n=5 Participants
Sex: Female, Male Male	332 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White	480 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian	82 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Black	21 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Mixed	20 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Other	9 Participants n=5 Participants
Number of children with existing asthma diagnosis Asthma Diagnosed Previously (on asthma register)	456 Participants n=5 Participants
Number of children with existing asthma diagnosis Asthma not diagnosed previously (not on asthma register)	156 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Spirometry attempted in all 612 children but only successful in 575

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

Outcome measures

Outcome measures
Measure	Study Cohort n=575 Participants Participating practices Ten practices participated in this study. They served a population of almost 120,000 people, ranging from \~3500 to 48000 registered patients. Geographically, five of the practices were located in inner-city Leicester, three were in surrounding towns, and two were in village locations. Participants Electronic database searches identified 1548 eligible children; 1097 (71%) were on their GPs asthma register, and 451 (29%) were not, but had received asthma medications in the previous 12 months. In total 614 children responded to the written invitations and attended clinics held between June 2016 and August 2017; of these, 456 (75%) were on the asthma register. Sixty-three percent of children were recruited in the months of March to August, and the remainder in the months of September to February. Written informed consent was obtained from carers of 613 children. One parent refused consent and one parent later withdrew their consent without giving a reason, leaving 612 children in total. The characteristics of recruited children are shown in table 1. Overall, the participation rate was 40% of eligible patients, but ranged from 8% to 59% between practices. The practice recruiting only 8% of eligible children was an outlier, and due in part to recruitment at this practice commencing late into the study and therefore fewer clinics (in relation to the practice size) were set up compared with other practices.
Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice Time to perform spirometry	4.3 Minutes Standard Deviation 1.3
Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice Time to perform reversibility test	3.1 Minutes Standard Deviation 1.0
Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice Time to perform eNO	2.4 Minutes Standard Deviation 1.0

PRIMARY outcome

Timeframe: 12 months

Population: Objective tests attempted in all 612 children with consent

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

Outcome measures

Outcome measures
Measure	Study Cohort n=612 Participants Participating practices Ten practices participated in this study. They served a population of almost 120,000 people, ranging from \~3500 to 48000 registered patients. Geographically, five of the practices were located in inner-city Leicester, three were in surrounding towns, and two were in village locations. Participants Electronic database searches identified 1548 eligible children; 1097 (71%) were on their GPs asthma register, and 451 (29%) were not, but had received asthma medications in the previous 12 months. In total 614 children responded to the written invitations and attended clinics held between June 2016 and August 2017; of these, 456 (75%) were on the asthma register. Sixty-three percent of children were recruited in the months of March to August, and the remainder in the months of September to February. Written informed consent was obtained from carers of 613 children. One parent refused consent and one parent later withdrew their consent without giving a reason, leaving 612 children in total. The characteristics of recruited children are shown in table 1. Overall, the participation rate was 40% of eligible patients, but ranged from 8% to 59% between practices. The practice recruiting only 8% of eligible children was an outlier, and due in part to recruitment at this practice commencing late into the study and therefore fewer clinics (in relation to the practice size) were set up compared with other practices.
Number of Children in Whom Usable Spirometry and eNO Data Can be Obtained	575 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Spirometry and FeNO data were available from 109 children who had received asthma medications in the previous year

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

Outcome measures

Outcome measures
Measure	Study Cohort n=109 Participants Participating practices Ten practices participated in this study. They served a population of almost 120,000 people, ranging from \~3500 to 48000 registered patients. Geographically, five of the practices were located in inner-city Leicester, three were in surrounding towns, and two were in village locations. Participants Electronic database searches identified 1548 eligible children; 1097 (71%) were on their GPs asthma register, and 451 (29%) were not, but had received asthma medications in the previous 12 months. In total 614 children responded to the written invitations and attended clinics held between June 2016 and August 2017; of these, 456 (75%) were on the asthma register. Sixty-three percent of children were recruited in the months of March to August, and the remainder in the months of September to February. Written informed consent was obtained from carers of 613 children. One parent refused consent and one parent later withdrew their consent without giving a reason, leaving 612 children in total. The characteristics of recruited children are shown in table 1. Overall, the participation rate was 40% of eligible patients, but ranged from 8% to 59% between practices. The practice recruiting only 8% of eligible children was an outlier, and due in part to recruitment at this practice commencing late into the study and therefore fewer clinics (in relation to the practice size) were set up compared with other practices.
The Number of Children in Whom a Diagnosis of Asthma Can be Confirmed Using Spirometry and eNO Testing	13 Participants

SECONDARY outcome

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

Population: Number of children with follow up data

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.

Outcome measures

Outcome measures
Measure	Study Cohort n=226 Participants Participating practices Ten practices participated in this study. They served a population of almost 120,000 people, ranging from \~3500 to 48000 registered patients. Geographically, five of the practices were located in inner-city Leicester, three were in surrounding towns, and two were in village locations. Participants Electronic database searches identified 1548 eligible children; 1097 (71%) were on their GPs asthma register, and 451 (29%) were not, but had received asthma medications in the previous 12 months. In total 614 children responded to the written invitations and attended clinics held between June 2016 and August 2017; of these, 456 (75%) were on the asthma register. Sixty-three percent of children were recruited in the months of March to August, and the remainder in the months of September to February. Written informed consent was obtained from carers of 613 children. One parent refused consent and one parent later withdrew their consent without giving a reason, leaving 612 children in total. The characteristics of recruited children are shown in table 1. Overall, the participation rate was 40% of eligible patients, but ranged from 8% to 59% between practices. The practice recruiting only 8% of eligible children was an outlier, and due in part to recruitment at this practice commencing late into the study and therefore fewer clinics (in relation to the practice size) were set up compared with other practices.
Change in Paediatric Asthma Quality of Life Questionnaire Score Measured at Enrolment and 3-6 Months Post-enrollment PAQLQ score at baselines	5.92 units on a scale Standard Deviation 1.06
Change in Paediatric Asthma Quality of Life Questionnaire Score Measured at Enrolment and 3-6 Months Post-enrollment PAQLQ score at follow up	6.02 units on a scale Standard Deviation 1.04

SECONDARY outcome

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

Population: Number of children with follow up data

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.

Outcome measures

Outcome measures
Measure	Study Cohort n=226 Participants Participating practices Ten practices participated in this study. They served a population of almost 120,000 people, ranging from \~3500 to 48000 registered patients. Geographically, five of the practices were located in inner-city Leicester, three were in surrounding towns, and two were in village locations. Participants Electronic database searches identified 1548 eligible children; 1097 (71%) were on their GPs asthma register, and 451 (29%) were not, but had received asthma medications in the previous 12 months. In total 614 children responded to the written invitations and attended clinics held between June 2016 and August 2017; of these, 456 (75%) were on the asthma register. Sixty-three percent of children were recruited in the months of March to August, and the remainder in the months of September to February. Written informed consent was obtained from carers of 613 children. One parent refused consent and one parent later withdrew their consent without giving a reason, leaving 612 children in total. The characteristics of recruited children are shown in table 1. Overall, the participation rate was 40% of eligible patients, but ranged from 8% to 59% between practices. The practice recruiting only 8% of eligible children was an outlier, and due in part to recruitment at this practice commencing late into the study and therefore fewer clinics (in relation to the practice size) were set up compared with other practices.
Change in Child Health Utility 9D Questionnaire Score Measured at Enrolment and at 3-6 Months Post-enrolment CHU9D score at baseline	0.88 score on a scale Standard Deviation 0.16
Change in Child Health Utility 9D Questionnaire Score Measured at Enrolment and at 3-6 Months Post-enrolment CHU9D score at follow up	0.85 score on a scale Standard Deviation 0.18

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Following training and implementation, 23 (85%) staff members responded to the online feedback questionnaire. Please note: healthcare providers were not considered enrolled within the study but did contribute feedback to this assessment.

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

Outcome measures

Outcome measures
Measure	Study Cohort n=23 Participants Participating practices Ten practices participated in this study. They served a population of almost 120,000 people, ranging from \~3500 to 48000 registered patients. Geographically, five of the practices were located in inner-city Leicester, three were in surrounding towns, and two were in village locations. Participants Electronic database searches identified 1548 eligible children; 1097 (71%) were on their GPs asthma register, and 451 (29%) were not, but had received asthma medications in the previous 12 months. In total 614 children responded to the written invitations and attended clinics held between June 2016 and August 2017; of these, 456 (75%) were on the asthma register. Sixty-three percent of children were recruited in the months of March to August, and the remainder in the months of September to February. Written informed consent was obtained from carers of 613 children. One parent refused consent and one parent later withdrew their consent without giving a reason, leaving 612 children in total. The characteristics of recruited children are shown in table 1. Overall, the participation rate was 40% of eligible patients, but ranged from 8% to 59% between practices. The practice recruiting only 8% of eligible children was an outlier, and due in part to recruitment at this practice commencing late into the study and therefore fewer clinics (in relation to the practice size) were set up compared with other practices.
The Number of Primary Care Staff Who Found Providing Spirometry and eNO Testing for Children Acceptable After Being Trained	23 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Feedback forms were completed by 554 (91%) families

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

Outcome measures

Outcome measures
Measure	Study Cohort n=554 Participants Participating practices Ten practices participated in this study. They served a population of almost 120,000 people, ranging from \~3500 to 48000 registered patients. Geographically, five of the practices were located in inner-city Leicester, three were in surrounding towns, and two were in village locations. Participants Electronic database searches identified 1548 eligible children; 1097 (71%) were on their GPs asthma register, and 451 (29%) were not, but had received asthma medications in the previous 12 months. In total 614 children responded to the written invitations and attended clinics held between June 2016 and August 2017; of these, 456 (75%) were on the asthma register. Sixty-three percent of children were recruited in the months of March to August, and the remainder in the months of September to February. Written informed consent was obtained from carers of 613 children. One parent refused consent and one parent later withdrew their consent without giving a reason, leaving 612 children in total. The characteristics of recruited children are shown in table 1. Overall, the participation rate was 40% of eligible patients, but ranged from 8% to 59% between practices. The practice recruiting only 8% of eligible children was an outlier, and due in part to recruitment at this practice commencing late into the study and therefore fewer clinics (in relation to the practice size) were set up compared with other practices.
The Number of Participants Who Found Spirometry and eNO Testing Acceptable	537 Participants

Adverse Events

Study Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Erol Gaillard

University of Leicester

Phone: +44116 252 3261

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place