Mediator Release During Exercise-induced Bronchoconstriction

B

Brunel University

Status

Unknown

Conditions

Exercise Induced Asthma

Treatments

Other: Exercise induced bronchoconstriction
Other: Inhibited EIB

Study type

Interventional

Funder types

Other

Identifiers

NCT03524053
8666

Details and patient eligibility

About

This study will compare the inflammatory response in induced vs inhibited exercise induced bronchoconstriction (EIB) in patients with a medical diagnosis of asthma/EIB. Urinary and plasma samples will be analysed to compare the mediator release in each condition, alongside changes in lung function.

Full description

Exercise induced-bronchoconstriction (EIB) is a transient narrowing of the airways that occurs during or shortly after strenuous exercise. The prevalence of EIB in asthmatic patients is estimated around 30-50%, but EIB can also occur in individuals without asthma (especially children, army recruit forces, and elite athletes). Controversy remains about the causative mediators in the bronchoconstrictive response. Technological advancement in mass spectrometry has opened new avenues in the quantitative measurement of small endogenous metabolites in biological fluids (including urine and blood), which may provide insights into the pathophysiology of EIB and direct future therapeutic targets. Utilising novel techniques in the analysis of inflammatory mediators in urine and blood, this study aims to conduct the most comprehensive analysis of mediator release during EIB to date. Participants will attend a screening visit during which they will complete an exercise challenge (to determine the presence of EIB). A skin prick test will also be conducted to establish the atopic status of the participants. Following the screening visit, patients with EIB will be invited to complete a randomised cross-over study, where they will perform two further exercise challenges on separate days: one while inhaling temperate dry air, and one while inhaling hot humid air (the latter is known to inhibit EIB). Lung function and breathing discomfort will be recorded, and urine and blood samples will be collected, before and at various time points after exercise. As a control condition, participants will also attend one visit during which no exercise will be performed. Participants aged 18-50yr, with diagnosed asthma and/or EIB, will be included in the study. 12 participants will complete 4 visits (lasting between 90 min and 4.5h). The study will take place on Brunel University London campus, Uxbridge. Urine and blood samples will be sent to the Karolinska Institutet, Stockholm, Sweden for analysis.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Able to understand the study instructions
  • Willing and able to give informed consent
  • Aged 18-50yr
  • Physician-diagnosed asthma and/or EIB
  • Participants that demonstrate EIB at the screening visit (i.e., those who have a fall in FEV1 20% to 50%) will be eligible for the full study.

Exclusion criteria

  • Any chronic medical condition other than asthma or EIB
  • Baseline FEV1 <70% predicted
  • Exacerbation of asthma or respiratory infection within the last 4 wk
  • Individuals who have varied their inhaled corticosteroid medication within the last 4 wk
  • History of anaphylaxis
  • Current smokers
  • Pregnancy
  • History of cardiovascular disease
  • Injury that would prevent exercise on a cycle ergometer
  • Medical contraindication to perform strenuous exercise
  • Required oral corticosteroids in the past 3 months
  • Any blood borne disease

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 3 patient groups

Exercise induced bronchoconstriction
Experimental group
Description:
An exercise challenge will then be performed according to international guidelines. The exercise will consist of 8 minutes of cycling on a cycle ergometer while breathing medical grade dry air from a reservoir (Douglas bag) via a two-way non-rebreathing valve. The workload will be increased progressively over the first 2 minutes, and will then be maintained for 6 minutes at a target workload (in Watts) of [53.76 * measured forced expiratory volume in 1 sec (FEV1)-11.07].
Treatment:
Other: Exercise induced bronchoconstriction
Inhibited EIB
Active Comparator group
Description:
An exercise challenge will then be performed according to international guidelines. The exercise will consist of 8 minutes of cycling on a cycle ergometer while warm-humid air from a reservoir (Douglas bag) via a two-way non-rebreathing valve. The workload will be increased progressively over the first 2 minutes, and will then be maintained for 6 minutes at a target workload (in Watts) of [53.76 * measured forced expiratory volume in 1 sec (FEV1)-11.07].
Treatment:
Other: Inhibited EIB
Control
No Intervention group
Description:
Participants will attend the laboratory but no exercise trial will be performed.

Trial contacts and locations

1

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Central trial contact

Hannah Marshall, MSc; Pascale Kippelen, PhD

Data sourced from clinicaltrials.gov

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