Exercise Induced AsthmaNCT03524053
Mediator Release During Exercise-induced Bronchoconstriction
A study testing Exercise induced bronchoconstriction and Inhibited EIB in people with Exercise Induced Asthma, run by Brunel University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Exercise Induced Asthma
- What is being tested?
- Exercise induced bronchoconstriction and Inhibited EIB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2018to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Brunel University London
Uxbridge, Middlesex, UB8 3PH
Hannah Marshall, MSc, +447584168742, hannah.marshall@brunel.ac.uk
Pascale Kippelen, PhD, 01895267649, pascale.kippelen@brunel.ac.uk
About this study
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.
Read the detailed 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.
- Conditions
- Exercise Induced Asthma
- Being tested
- Exercise induced bronchoconstriction, Inhibited EIB
- Medical subject headings
- Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise induced bronchoconstrictionOther
Also called Induced bronchoconstriction
Participants will exercise whilst inhaling dry-air, this is known to exacerbate the bronchoconstrictive response.
Inhibited EIBOther
Also called Exercise-control
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise induced bronchoconstriction | Experimental | 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]. Receives: Other: Exercise induced bronchoconstriction |
| Inhibited EIB | Active comparator | 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]. Receives: Other: Inhibited EIB |
| Control | No intervention | Participants will attend the laboratory but no exercise trial will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Concentration of tryptase and pro-inflammatory cytokines measured from blood plasma samples.
Measured: 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
Forced expiratory volume in one second (FEV1) measured in litres will be used to determine the severity of EIB from baseline to post-exercise challenge.
Measured: 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
Breathing rate (breaths per minute) will be recorded throughout exercise to control intensity between trials.
Measured: Continuous recording throughout 8-min exercise test using the online breath-by-breath analysis system.
Heart rate
Heart rate (beats per minute) will be recorded throughout the exercise challenge test to control intensity between trials.
Measured: 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
Modified Borg scale (0- no discomfort, 10- severe discomfort).
Measured: Breathing discomfort severity ratings will be recorded every 2 minutes throughout the 8 min exercise test (a total of 4 measurements)
Description of breathing discomfort
Descriptors from patients to describe the level of discomfort - i.e. 'my chest is tight'.
Measured: A description of breathing discomfort will be recorded every 2 minutes throughout the 8 min exercise test (a total of 4 measurements)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start1 Nov 2018
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Induced AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will undertake 3 separate conditions in a randomised order.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brunel University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Hannah Marshall, Brunel University
- Investigators
- Hannah Marshall, MSc, Principal investigator, Brunel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524053
- Sponsor's protocol ID
- 8666
- Status last verified
- Jan 2019
- First submitted
- 20 Apr 2018
- Last updated
- 29 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediator Release During Exercise-induced Bronchoconstriction
- ClinicalTrials.gov ID
- NCT03524053
- Acronym / sponsor ID
- 8666
- Conditions
- Exercise Induced Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Brunel UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will undertake 3 separate conditions in a randomised order.
| Arm | Type | Receives |
|---|---|---|
| Exercise induced bronchoconstriction | Experimental | Other: Exercise induced bronchoconstrictionAn 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 comparator | Other: Inhibited EIBAn 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 intervention | –Participants will attend the laboratory but no exercise trial will be performed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise induced bronchoconstrictionAlso: Induced bronchoconstrictionParticipants will exercise whilst inhaling dry-air, this is known to exacerbate the bronchoconstrictive response. | Other | Exercise induced bronchoconstriction |
| Inhibited EIBAlso: Exercise-controlParticipants 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 | Inhibited EIB |
Primary outcome
Changes in the concentration of inflammatory mediator metabolites in urine
Time frame: 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.
Concentration of metabolites of prostaglandin-D2, Cysteinyl-Leukotrienes, prostaglandin-E2, prostacyclin, thromboxane and isoprostanes will be expressed as pg per mmol of creatinine.
6 secondary outcomes
Changes in the concentration of inflammatory mediator metabolites in blood plasma
Time frame: 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
Time frame: 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
Time frame: Continuous recording throughout 8-min exercise test using the online breath-by-breath analysis system.
Heart rate
Time frame: 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
Time frame: Breathing discomfort severity ratings will be recorded every 2 minutes throughout the 8 min exercise test (a total of 4 measurements)
Description of breathing discomfort
Time frame: A description of breathing discomfort will be recorded every 2 minutes throughout the 8 min exercise test (a total of 4 measurements)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Marshall, MSc principal investigator
Brunel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise induced bronchoconstriction and Inhibited EIB in people with Exercise Induced Asthma, run by Brunel University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Marshall, MSc (+447584168742, hannah.marshall@brunel.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the concentration of inflammatory mediator metabolites in urine (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.