NCT07129616

Brief Summary

The objective of this study is to determine whether healthcare data and remotely collected patient data can accurately predict asthma attacks in children and young people aged 5-17 years. The main outcome is: when using this new system, is there a reduction in asthma attacks compared with a historic average. The whole population of children and young people with asthma will have routine healthcare data monitored, with a subset of people with high risk asthma asked to participate in a more detail study involving remotely monitored data.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Nov 2025Mar 2027

First Submitted

Initial submission to the registry

August 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

November 20, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 22, 2026

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

August 11, 2025

Last Update Submit

January 20, 2026

Conditions

Keywords

asthma attack risk reductionremote monitoring

Outcome Measures

Primary Outcomes (1)

  • Number of asthma attacks

    Change in primary care prescriptions for asthma attack medication (Prednisolone or similar) in the population utilising this new system compared with a historical asthma population from the same location.

    6 months

Secondary Outcomes (12)

  • Number identified as high risk

    6 months

  • Rate of symptoms reported

    6 months

  • Interventions required

    6 months

  • Number of hospital asthma attacks

    6 months

  • Number of life threatening attacks

    6 months

  • +7 more secondary outcomes

Study Arms (2)

Whole population with asthma within a single primary care cluster

Subset of this cohort, identified as being at high risk of an asthma attack

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The whole population of those with asthma from an individual primary care cluster within NHS Lothian.

You may qualify if:

  • Children and Young People with a diagnosis of asthma (coded as asthma or suspected asthma) or a prescription of inhaled corticosteroid in the prior 2 years.

You may not qualify if:

  • Alternative non-asthma diagnosis that would require inhaled steroid
  • cystic fibrosis
  • bronchiectasis
  • primary ciliary dyskinaesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

RECRUITING

Related Publications (1)

  • Buelo A, McLean S, Julious S, Flores-Kim J, Bush A, Henderson J, Paton JY, Sheikh A, Shields M, Pinnock H; ARC Group. At-risk children with asthma (ARC): a systematic review. Thorax. 2018 Sep;73(9):813-824. doi: 10.1136/thoraxjnl-2017-210939. Epub 2018 Jun 5.

    PMID: 29871982BACKGROUND

Related Links

Central Study Contacts

kenneth a macleod, MbChB, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 19, 2025

Study Start

November 20, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

January 22, 2026

Record last verified: 2025-09

Locations