NCT05848791

Brief Summary

The goal of this observational study is to explore the health impacts of exposure to nontailpipe vehicle air pollution. The main question it aims to answer is: Does short term exposure to increased non-tailpipe course mode PM induce negative respiratory responses in adults living with asthma? We will recruit 48 non-smoking adults with mild-moderate asthma. Participants will be recruited from central and east London Participants will be exposed to three contrasting air quality environments, in field laboratories at the following locations:

  1. 1.High-speed continuous traffic location, to enhance tire wear emissions
  2. 2.An urban background location away from nearby traffic sources
  3. 3.A busy road junction characterized by stop-go traffic to enhance emissions from brake wear

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

April 13, 2023

Last Update Submit

March 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Forced Expiratory volume in one Second (FEV1)

    FEV1 as measured by spirometry

    0 hours and 2.5hours.

Secondary Outcomes (5)

  • Change in Forced Vital Capacity (FVC)

    0 hours, 2.5hours and 26 hours

  • Change in Fractional expired Nitric Oxide

    0 hours, 2.5hours and 26 hours

  • Change in Daily asthma symptoms

    0 hours, 2.5hours and 26 hours

  • Change in Immune response

    0 hours, 2.5hours and 26 hours

  • Change in Airway resistance

    0 hours, 2.5hours and 26 hours

Interventions

Participants are exposed to three different air quality environments in central London, chosen to maximise differences in nontailpipe air pollution. Participants will cycle at 60% of estimated maximum vo2 on static bikes for six 15 minute bouts with 15 minutes rest between bouts.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from universities and general practices in London.

You may qualify if:

  • Doctor diagnosed asthma starting on or before age 16 years
  • Prescribed regular inhaled corticosteroid medication
  • Able to use a static exercise bicycle for the study duration

You may not qualify if:

  • Tobacco smoking, or living with smoker
  • Body mass index (BMI) \> 30
  • Asthma hospitalisation within 12 months
  • Three or more asthma episodes requiring oral corticosteroid medication within 12 months
  • Other major lung disease
  • Chest surgery within 6 months
  • Unable to give informed consent
  • Occupational exposure to particulate matter (PM) or high levels of air pollution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary University London

London, E1 2A, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Plasma. Nasal Mucus. Urine.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • James Scales, PhD

    Queen Mary University London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow (AUKCAR)

Study Record Dates

First Submitted

April 13, 2023

First Posted

May 8, 2023

Study Start

December 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations