Mediator Release During Exercise-induced Bronchoconstriction
NCT ID: NCT03524053
Last Updated: 2019-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2018-11-01
2020-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Exercise induced bronchoconstriction
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 \[53.76 \* measured forced expiratory volume in 1 sec (FEV1)-11.07\].
Exercise induced bronchoconstriction
Participants will exercise whilst inhaling dry-air, this is known to exacerbate the bronchoconstrictive response.
Inhibited EIB
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 \[53.76 \* measured forced expiratory volume in 1 sec (FEV1)-11.07\].
Inhibited EIB
Participants will perform the exercise-test whilst inhaling warm-humid air. This is known to inhibit the EIB response and will provide a direct comparison group for the EIB condition.
Control
Participants will attend the laboratory but no exercise trial will be performed.
No interventions assigned to this group
Interventions
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Exercise induced bronchoconstriction
Participants will exercise whilst inhaling dry-air, this is known to exacerbate the bronchoconstrictive response.
Inhibited EIB
Participants will perform the exercise-test whilst inhaling warm-humid air. This is known to inhibit the EIB response and will provide a direct comparison group for the EIB condition.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Brunel University
OTHER
Responsible Party
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Hannah Marshall
PhD Research Student
Principal Investigators
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Hannah Marshall, MSc
Role: PRINCIPAL_INVESTIGATOR
Brunel University
Locations
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Brunel University London
Uxbridge, Middlesex, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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8666
Identifier Type: -
Identifier Source: org_study_id
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