Trial Outcomes & Findings for Using Tests in Preschool Children With Wheeze to Determine the Need for Inhaled Corticosteroid Therapy. (NCT NCT04942483)

NCT ID: NCT04942483

Last Updated: 2025-07-24

Results Overview

Defined as requiring an unscheduled healthcare visit to the ED or GP.

• Recruitment status: COMPLETED
• Target enrollment: 118 participants
• Primary outcome timeframe: 1-year follow-up
• Results posted on: 2025-07-24

Participant Flow

Only children 1-5 years old were considered enrolled. Their parents/guardians were not considered as enrolled. They signed the consent form for enrolment and complete the monthly questionnaires during follow-up on behalf of their child. No interventions were performed in this study. There were no arms in this study, only a single group followed in an identical manner.

Participant milestones

Measure	Preschool Children Aged 1 to 5 Years Old Preschool children with a history of ≥1 doctor-diagnosed acute wheeze attack of any severity, in the year prior to baseline measurement.
Overall Study STARTED	118
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using Tests in Preschool Children With Wheeze to Determine the Need for Inhaled Corticosteroid Therapy.

Baseline characteristics by cohort

Measure	Preschool Children Aged 1 to 5 Years Old n=95 Participants Preschool children with a history of ≥1 doctor-diagnosed acute wheeze attack of any severity, in the year prior to baseline measurement.
Age, Continuous	35 months n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	86 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	95 participants n=5 Participants
Blood eosinophil count	400 cells/μL n=5 Participants
Fractional exhaled nitric oxide	8 ppb n=5 Participants
Atopy	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-year follow-up

Population: Data only applies to children aged 1-5 years old. There were no arms in this study, only a single group followed in an identical manner.

Defined as requiring an unscheduled healthcare visit to the ED or GP.

Outcome measures

Measure	Preschool Children Aged 1-5 Years n=95 Participants Preschool children aged 1-5 years followed for a period of 12 months. There were no arms in this study, only a single group followed in an identical manner.
Wheeze Attacks	1 Wheeze attacks Interval 0.0 to 9.0

SECONDARY outcome

Timeframe: 1 year follow-up period

Population: Data only applies to children aged 1-5 years old and not their parents. There were no arms in this study, only a single group followed in an identical manner.

Children unable to attend childcare facility due to a wheeze attack. There were no arms in this study, only a single group followed in an identical manner.

Outcome measures

Measure	Preschool Children Aged 1-5 Years n=95 Participants Preschool children aged 1-5 years followed for a period of 12 months. There were no arms in this study, only a single group followed in an identical manner.
Days Out of Nursery	3 days Interval 0.0 to 33.0

SECONDARY outcome

Timeframe: 1 year follow-up period

Population: Data only apply to parents of preschool children. There were no arms in this study, only a single group followed in an identical manner. Every month parents would be asked to state whether they needed to take any days of work due to their child's wheeze.

Days out of work parents needed to take because of their child's wheeze attack. There were no arms in this study, only a single group followed in an identical manner.

Outcome measures

Measure	Preschool Children Aged 1-5 Years n=95 Participants Preschool children aged 1-5 years followed for a period of 12 months. There were no arms in this study, only a single group followed in an identical manner.
Parents Days Out of Work	3 days Interval 0.0 to 33.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12-months

Population: Only 16 out of 95 parents agreed to participate in these focus group discussions.

The acceptability of the three biomarker tests by parents to be used in clinical practice was assessed through focus group discussions.

Outcome measures

Measure	Preschool Children Aged 1-5 Years n=16 Participants Preschool children aged 1-5 years followed for a period of 12 months. There were no arms in this study, only a single group followed in an identical manner.
Acceptability of Biomarker Tests by Parents	16 Participants

Adverse Events

Preschool Children Aged 1 to 5 Years Old

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

Professor Andrew Bush

Imperial College London

Phone: 020 7352 8121

Email: a.bush@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place