Mediator Release During Exercise-induced Bronchoconstriction
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2018
1 active site
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
First Submitted
Initial submission to the registry
April 20, 2018
CompletedFirst Posted
Study publicly available on registry
May 14, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedJanuary 29, 2019
January 1, 2019
1.3 years
April 20, 2018
January 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in the concentration of inflammatory mediator metabolites in urine
Concentration of metabolites of prostaglandin-D2, Cysteinyl-Leukotrienes, prostaglandin-E2, prostacyclin, thromboxane and isoprostanes will be expressed as pg per mmol of creatinine.
Urine sample will be collected 45 minutes and immediately prior to the exercise challenges (or controlled resting period) and at 45, 90, 135 and 180 minutes post-exercise.
Secondary Outcomes (6)
Changes in the concentration of inflammatory mediator metabolites in blood plasma
Urine sample will be collected 45 minutes and immediately prior to the exercise challenges (or controlled resting period) and at 45, 90, 135 and 180 minutes post-exercise.
Forced vital capacity (FVC) manoeuvres using spirometry
Spirometry will be performed 45 minutes and immediately prior to the exercise challenges (or controlled resting period) and at 45, 90, 135 and 180 minutes post-exercise.
Breathing rate
Continuous recording throughout 8-min exercise test using the online breath-by-breath analysis system.
Heart rate
Continuous recording continuously throughout the 8-min exercise test using short-range radiotelemetry using a chest belt worn by the participant.
Rating of breathing discomfort
Breathing discomfort severity ratings will be recorded every 2 minutes throughout the 8 min exercise test (a total of 4 measurements)
- +1 more secondary outcomes
Study Arms (3)
Exercise induced bronchoconstriction
EXPERIMENTALAn 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 \[53.76 \* measured forced expiratory volume in 1 sec (FEV1)-11.07\].
Inhibited EIB
ACTIVE COMPARATORAn 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 \[53.76 \* measured forced expiratory volume in 1 sec (FEV1)-11.07\].
Control
NO INTERVENTIONParticipants will attend the laboratory but no exercise trial will be performed.
Interventions
Participants will exercise whilst inhaling dry-air, this is known to exacerbate the bronchoconstrictive response.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brunel Universitylead
- Karolinska Institutetcollaborator
Study Sites (1)
Brunel University London
Uxbridge, Middlesex, UB8 3PH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hannah Marshall, MSc
Brunel University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Research Student
Study Record Dates
First Submitted
April 20, 2018
First Posted
May 14, 2018
Study Start
November 1, 2018
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
January 29, 2019
Record last verified: 2019-01