Exercise Induced AsthmaNCT01942096
Study of Airway Inflammation in Relation to Exercise in Elite Athletes
An observational study of Exercise Induced Asthma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
High school elite training programs are today more and more under development in several 'elite sport schools' in Belgium, in order to select and train future elite athletes already at young age. Read more about this study
- Who is it for?
- Ages 14 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Induced Asthma
- How many people
- 66 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2011to Aug 2013
- Phase
- Observational
- 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 14 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Competitive swimmers, competitive indoor athletes and healthy individuals
Who may be able to join
- Performing sports at national or international level (swimmers and indoor athletes)
Who cannot join
- Performing sport at recreational level (not more than 4 hours/week for healthy individuals)
Trial locations and contacts
1 site in 1 country.
About this study
High school elite training programs are today more and more under development in several 'elite sport schools' in Belgium, in order to select and train future elite athletes already at young age. Little is known about the effects of sustained training on the potential development of asthma in adolescents during lung growth. It would be of great importance to be able to select the individuals at risk to develop exercise-induced asthma, already at the start of their enrollment in the 'elite sport school. This would allow physicians to follow their lung function parameters very closely and regularly; and, if necessary, start treatment early after the first signs of exercise-induced asthma.
Read the detailed description
Competitive swimmers, competitive indoor athletes and control individuals performing sports at a recreational level will be recruited for the study.
They will perform a sport-specific training (swimmers and controls: swimming for 90 minutes, indoor athletes: basketball or volleyball for 90 minutes)
Baseline measurements:
- Airway inflammation upper and lower airways will be assessed by collection of nasal fluid (nasal sponge will be inserted in nostril for 5 minutes), Fraction of exhaled Nitric Oxide measurement and sputum induction.
- Upper and lower airway symptoms will be assessed by questionnaires (SinoNasal Outcome Measure-22, Visual Analogue Score, Asthma Symptom Score and Juniper Score)
- Allergy will be assessed by skin prick test (on skin) and immunocap test (in blood, 1 tube of 10 ml).
- Lung function and nasal patency will be measured by spirometry and Peak Nasal Inspiratory Flow measurement.
- Exercise induced bronchoconstriction will be assessed by eucapnic voluntary hyperventilation test.
Measurements immediately after training:
- Collection of nasal fluid
- Assessment of upper airway symptoms (Visual Analogue Score)
- Spirometry and Fraction of Exhaled Nitric Oxide measurement
- Peak Nasal Inspiratory Flow measurement
Measurements 24 hours after training:
- Collection of nasal fluid
- Assessment of upper airway symptoms (Visual Analogue Score)
- Spirometry and Fraction of Exhaled Nitric Oxide measurement
- Peak Nasal Inspiratory Flow measurement
- Sputum induction
- Venous puncture (1 tube of 10 ml)
- Conditions
- Exercise Induced Asthma
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Competitive swimmers | Swimmers performing at national or international level | |
| Competitive indoor athletes | Indoor athletes performing at national or international level | |
| Healthy control individuals | Individuals performing sports at a recreational level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of airway inflammation
Airway inflammation upper and lower airways will be assessed by collection of nasal fluid (nasal sponge will be inserted in nostril for 5 minutes), Fraction of exhaled Nitric Oxide measurement and sputum induction.
Measured: Baseline, immediately after and 24 hours after sport-specific training
Secondary outcomes (1)
Measurement of exercise induced bronchoconstriction
Exercise induced bronchoconstriction will be assessed by eucapnic voluntary hyperventilation test.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startDec 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exercise Induced AsthmaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominque Bullens, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Sven F Seys, MSc, Study director, lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 LeuvenValerie Hox, MD, Study director, lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942096
- Sponsor's protocol ID
- ML7650
- Status last verified
- Jul 2018
- First submitted
- 26 Aug 2013
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Overall results are presented in a closed session for participants and parents. Confidential individual data are afterwards discussed with the respective parents and participants.
Publications
Steelant B, Hox V, Van Gerven L, Dilissen E, Dekimpe E, Kasran A, Aertgeerts S, Van Belle V, Peers K, Dupont LJ, Hellings PW, Bullens DM, Seys SF. Nasal symptoms, epithelial injury and neurogenic inflammation in elite swimmers. Rhinology. 2018 Sep 1;56(3):279-287. doi: 10.4193/Rhin17.167.
PubMed 29561921Seys SF, Hox V, Van Gerven L, Dilissen E, Marijsse G, Peeters E, Dekimpe E, Kasran A, Aertgeerts S, Troosters T, Vanbelle V, Peers K, Ceuppens JL, Hellings PW, Dupont LJ, Bullens DM. Damage-associated molecular pattern and innate cytokine release in the airways of competitive swimmers. Allergy. 2015 Feb;70(2):187-94. doi: 10.1111/all.12540.
PubMed 25358760
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Airway Inflammation in Relation to Exercise in Elite Athletes
- ClinicalTrials.gov ID
- NCT01942096
- Acronym / sponsor ID
- ML7650
- Conditions
- Exercise Induced Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Sep 2013 (estimated)
- 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.
High school elite training programs are today more and more under development in several 'elite sport schools' in Belgium, in order to select and train future elite athletes already at young age. Little is known about the effects of sustained training on the potential development of asthma in adolescents during lung growth. It would be of great importance to be able to select the individuals at risk to develop exercise-induced asthma, already at the start of their enrollment in the 'elite sport school. This would allow physicians to follow their lung function parameters very closely and regularly; and, if necessary, start treatment early after the first signs of exercise-induced asthma.
Detailed description
Competitive swimmers, competitive indoor athletes and control individuals performing sports at a recreational level will be recruited for the study.
They will perform a sport-specific training (swimmers and controls: swimming for 90 minutes, indoor athletes: basketball or volleyball for 90 minutes)
Baseline measurements:
- Airway inflammation upper and lower airways will be assessed by collection of nasal fluid (nasal sponge will be inserted in nostril for 5 minutes), Fraction of exhaled Nitric Oxide measurement and sputum induction.
- Upper and lower airway symptoms will be assessed by questionnaires (SinoNasal Outcome Measure-22, Visual Analogue Score, Asthma Symptom Score and Juniper Score)
- Allergy will be assessed by skin prick test (on skin) and immunocap test (in blood, 1 tube of 10 ml).
- Lung function and nasal patency will be measured by spirometry and Peak Nasal Inspiratory Flow measurement.
- Exercise induced bronchoconstriction will be assessed by eucapnic voluntary hyperventilation test.
Measurements immediately after training:
- Collection of nasal fluid
- Assessment of upper airway symptoms (Visual Analogue Score)
- Spirometry and Fraction of Exhaled Nitric Oxide measurement
- Peak Nasal Inspiratory Flow measurement
Measurements 24 hours after training:
- Collection of nasal fluid
- Assessment of upper airway symptoms (Visual Analogue Score)
- Spirometry and Fraction of Exhaled Nitric Oxide measurement
- Peak Nasal Inspiratory Flow measurement
- Sputum induction
- Venous puncture (1 tube of 10 ml)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Competitive swimmers | – | –Swimmers performing at national or international level |
| Competitive indoor athletes | – | –Indoor athletes performing at national or international level |
| Healthy control individuals | – | –Individuals performing sports at a recreational level |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Competitive swimmers, competitive indoor athletes and healthy individuals
Key inclusion criteria (1 listed)
- Performing sports at national or international level (swimmers and indoor athletes)
Key exclusion criteria (1 listed)
- Performing sport at recreational level (not more than 4 hours/week for healthy individuals)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of airway inflammation
Time frame: Baseline, immediately after and 24 hours after sport-specific training
Airway inflammation upper and lower airways will be assessed by collection of nasal fluid (nasal sponge will be inserted in nostril for 5 minutes), Fraction of exhaled Nitric Oxide measurement and sputum induction.
1 secondary outcome
Measurement of exercise induced bronchoconstriction
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Results publication: PubMed 29561921Steelant B, Hox V, Van Gerven L, Dilissen E, Dekimpe E, Kasran A, Aertgeerts S, Van Belle V, Peers K, Dupont LJ, Hellings PW, Bullens DM, Seys SF. Nasal symptoms, epithelial injury and neurogenic inflammation in elite swimmers. Rhinology. 2018 Sep 1;56(3):279-287. doi: 10.4193/Rhin17.167.
- Results publication: PubMed 25358760Seys SF, Hox V, Van Gerven L, Dilissen E, Marijsse G, Peeters E, Dekimpe E, Kasran A, Aertgeerts S, Troosters T, Vanbelle V, Peers K, Ceuppens JL, Hellings PW, Dupont LJ, Bullens DM. Damage-associated molecular pattern and innate cytokine release in the airways of competitive swimmers. Allergy. 2015 Feb;70(2):187-94. doi: 10.1111/all.12540.
- Individual participant dataSharing planned: Yes. Overall results are presented in a closed session for participants and parents. Confidential individual data are afterwards discussed with the respective parents and participants.
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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.
Sven F Seys, MSc study director
lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven
Valerie Hox, MD study director
lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Induced Asthma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Jul 2018. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of airway inflammation (time frame: Baseline, immediately after and 24 hours after sport-specific training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01942096, which also lists 2 linked publications.
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 16 Jul 2018.