Mediator Release During Exercise-induced Bronchoconstriction

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03524053
Study type	Interventional
Source	Brunel University
Contact	Hannah Marshall, MSc
Phone	+447584168742
Email	hannah.marshall@brunel.ac.uk
Status	Recruiting
Phase	N/A
Start date	November 1, 2018
Completion date	March 2020

View Details

See also
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Completed	`NCT00861185` - Study to Assess Safety and Efficacy of Oral Senicapoc Administration on Exercise-induced Asthma	Phase 2
Completed	`NCT05703334` - Kt and Myofascial Release in Exc Asthma	N/A
Recruiting	`NCT05105529` - Adaptation to Ozone in Individuals With Asthma/Exercise-induced Bronchoconstriction	N/A
Terminated	`NCT01070888` - Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma	Phase 4
Recruiting	`NCT06336681` - Inspiratory Muscle Training on The Severity of Exercise-Induced Bronchoconstriction and Time-Trial Performance (IMT_EIB)	Phase 2
Completed	`NCT01942096` - Study of Airway Inflammation in Relation to Exercise in Elite Athletes
Completed	`NCT00127166` - Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)	Phase 3
Recruiting	`NCT05174689` - Epigenetic Regulation of Exercise Induced Asthma	N/A
Completed	`NCT01097954` - A Prospective Study Measuring Exhaled Nitric Oxide in Exercise-Induced Asthma

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.