Children's Health, Respiratory Inflammation and Short-ter... | NCT07431021

Studies
Children's Health, Respiratory Inflammation and Short-term Air Pollution

NCT07431021

Sponsor

Queen Mary University of London

Status

Recruiting

Last Update Posted

Jun 15, 2026Actual

Enrollment

330Estimated

Phase

Not Applicable

Conditions

Asthma Acute
Respiratory

Interventions

science lesson
PE Lesson

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
G-002887	Other Grant/Funding Number	Barts Charity

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2025Actual

Primary Completion Date

Jul 1, 2027Estimated

Completion Date

Jul 1, 2027Estimated

First Submitted Date

Feb 3, 2026

First Submission Date that Met QC Criteria

Feb 20, 2026

First Posted Date

Feb 24, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2026

Last Update Posted Date

Jun 15, 2026Actual

Name	Class
Imperial College London	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this study is to see if physical activity in high air pollution is worse than rest in high air pollution.

Detailed Description

The study will recruit a total of 330 children from 10 primary schools split into two groups: "higher pollution" and "lower pollution" schools. The team shall invite children in years 3 to 6 to take part in the study and consent will be provided by parents following information sheets sent home in school bags and parent evening presentations.

After the team have received written permission from parents. The study team will visit the school on two days. On the first day the study team will perform lung health assessment in a dedicated classroom. The assessment will involve, measuring children's height and weight, a breathing test (photo and a snot sample collected by squirting a small bit of saline water up one nostril and catching the snot in a cup.

Children will then take part in a PE lesson or a sedentary science lesson in a random order in their school playground while wearing activity monitors - like a Fitbit- to track their physical activity. The session is designed to be just like a typical outdoor science or PE lesson and will be exactly the same at all schools. Air pollution levels in the playground will be monitored during this time.

Once the PE lesson has finished the children will perform the same health assessment immediately after the lesson and again on a second day. The team shall compare the change in these scores between higher and lower pollution schools. The breathing tests will tell us if the has been any change in lung health and the snot samples will tell us about the pollution the children have breathed and how their bodies try to fight it. Participating will take about 4 hours total.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

330Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Physical activity	Experimental	PE Lesson	Behavioral: PE Lesson
Sedenary	Active Comparator	Science lesson	Behavioral: science lesson

Interventions

Name	Type	Description	Arm Group Labels	Other Names
science lesson	Behavioral	children have a 90 minute science lesson outdoors	Sedenary

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
"Airway resistance" measured by Oscillometry at R5	measured as oscillometery R5	Pre-24 hour post exposure

Secondary Outcomes

Measure	Description	Time Frame
"Small airway resistance" measured by Oscillometry at R5-20	Measured by oscillometry R5-20	pre- 24 hour post exposure
Immune responses as measured by Il6 in nasal lavage	Immune response as measured by Il6 in nasal lavage

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Attending schools in Central and East London that have been recruited to the study

Exclusion Criteria:

Not able to engage with PE lessons on safety grounds, reported by their parents.
Children with learning or physical disabilities sufficient for them to be unable to give informed assent to the study, or to carry out study procedures

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
James Scales, PhD	Contact	+447533897264		j.scales@qmul.ac.uk
Abigail Whitehouse, MD,PhD	Contact			a.whitehouse@qmul.ac.uk

Overall Officials

Name	Affiliation	Role
James Scales, PhD	Queen Mary University London	Principal Investigator
Abigail Whitehouse, PhD, MD	QMUL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine and Dentistry	Recruiting	London		E1 2AB	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 28, 2025	Oct 28, 2025	Prot_000.pdf
ICF	No	No	Yes	Informed Consent Form	Oct 10, 2025	Oct 28, 2025	ICF_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity

Ancestor Terms

ID	Term
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided