Asthmaproto nageNCT00686452
Airway Dysfunction and Remodelling in Athletes Following Swimming Training in Chlorinated Pools
An observational study of Asthma and Airway Hyperresponsiveness, run by Laval University at 1 site in Canada.
Trial summary
Swimmers show the highest prevalence of asthma among elite athletes, certainly due to chlorine exposure. The consequences of a chronic exposure to chlorine compounds by swimmers and the mechanisms of asthme in this population are still poorly documented. Read more about this study
- Who is it for?
- Ages 14 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Airway Hyperresponsiveness
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2007to May 2009
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Swimmers from Quebec swimming school and universities Control from université Laval or secondary School
Who may be able to join
- 14 to 35 years old
- To swim at least 10h per week
- For control subjects, non-competitive healthy subjects
Who cannot join
- any disease that may interfere with the tests for the controls
- Triathletes are excluded
- Smokers
- Obese or with a BMI more than 29
- Former athletes (control group)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche en pneumologie et en cardiologie de l'hôpital Laval
Québec, Quebec, G1V4G5
Valerie BOUGAULT, PhD, 418-656-8711 ext. 1507, valerie.bougault@crhl.ulaval.ca
Louis-Philippe BOULET, MD, lpboulet@crhl.ulaval.ca
About this study
Swimmers show the highest prevalence of asthma among elite athletes, certainly due to chlorine exposure. The consequences of a chronic exposure to chlorine compounds by swimmers and the mechanisms of asthme in this population are still poorly documented. Specific diagnostic criteria have been proposed by the International Olympic Committee - Medical Council (IOC-MC) and World anti-doping agency (WADA) to determine the presence of asthma in athletes. Using the more specific bronchial provocation tests, our aims are
- to compare the prevalence of asthma in swimmers and control subjects
- to analyze the Influence of chlorine exposure on bronchial inflammatory processes in swimmers versus control subjects
- to study the time-course of changes in airway symptoms, responsiveness, inflammation and remodeling after cessation of training
- Conditions
- Asthma, Airway Hyperresponsiveness
- Keywords
- Asthma, Airway hyperresponsiveness, Swimmers, Airway inflammation, Airway remodelling
- Medical subject headings
- Asthma, Respiratory Hypersensitivity, Airway Remodeling
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 |
|---|---|---|
| 1 | Swimmers without AHR | |
| 2 | Swimmers with asymptomatic AHR | |
| 3 | Swimmers with symptomatic AHR and use only of beta-2 adrenargic | |
| 4 | Swimmers with asthma and inhaled corticosteroids | |
| 5 | Healthy Subjects | |
| 6 | Healthy subjects with AHR | |
| 7 | Healthy subjects with symptomatic AHR (asthma) but without treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma and airway hyperreactivity prevalence in swimmers
Measured: 3 measurements in the year
Secondary outcomes (1)
Airway inflammation and remodeling in swimmers
Measured: 3 measurements in the year and a bronchial biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startMar 2007
- Primary completionMay 2009 (estimated)
- Study completionMay 2009 (estimated)
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 AsthmaStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686452
- Sponsor's protocol ID
- CER20159
- Acronym
- proto nage
- Status last verified
- May 2008
- First submitted
- 26 May 2008
- Last updated
- 22 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Bougault V, Odashiro P, Turmel J, Orain M, Laviolette M, Joubert P, Boulet LP. Changes in airway inflammation and remodelling in swimmers after quitting sport competition. Clin Exp Allergy. 2018 Dec;48(12):1748-1751. doi: 10.1111/cea.13257. Epub 2018 Sep 14. No abstract available.
PubMed 30141830Bougault V, Turmel J, Boulet LP. Bronchial challenges and respiratory symptoms in elite swimmers and winter sport athletes: Airway hyperresponsiveness in asthma: its measurement and clinical significance. Chest. 2010 Aug;138(2 Suppl):31S-37S. doi: 10.1378/chest.09-1689. Epub 2010 Apr 2.
PubMed 20363843
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Dysfunction and Remodelling in Athletes Following Swimming Training in Chlorinated Pools
- ClinicalTrials.gov ID
- NCT00686452
- Acronym / sponsor ID
- proto nage / CER20159
- Conditions
- Asthma, Airway Hyperresponsiveness
- Keywords
- Asthma, Airway hyperresponsiveness, Swimmers, Airway inflammation, Airway remodelling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- May 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 29 May 2008 (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.
Swimmers show the highest prevalence of asthma among elite athletes, certainly due to chlorine exposure. The consequences of a chronic exposure to chlorine compounds by swimmers and the mechanisms of asthme in this population are still poorly documented. Specific diagnostic criteria have been proposed by the International Olympic Committee - Medical Council (IOC-MC) and World anti-doping agency (WADA) to determine the presence of asthma in athletes. Using the more specific bronchial provocation tests, our aims are
- to compare the prevalence of asthma in swimmers and control subjects
- to analyze the Influence of chlorine exposure on bronchial inflammatory processes in swimmers versus control subjects
- to study the time-course of changes in airway symptoms, responsiveness, inflammation and remodeling after cessation of training
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Swimmers without AHR |
| 2 | – | –Swimmers with asymptomatic AHR |
| 3 | – | –Swimmers with symptomatic AHR and use only of beta-2 adrenargic |
| 4 | – | –Swimmers with asthma and inhaled corticosteroids |
| 5 | – | –Healthy Subjects |
| 6 | – | –Healthy subjects with AHR |
| 7 | – | –Healthy subjects with symptomatic AHR (asthma) but without treatment |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Swimmers from Quebec swimming school and universities Control from université Laval or secondary School
Key inclusion criteria (3 listed)
- 14 to 35 years old
- To swim at least 10h per week
- For control subjects, non-competitive healthy subjects
Key exclusion criteria (5 listed)
- any disease that may interfere with the tests for the controls
- Triathletes are excluded
- Smokers
- Obese or with a BMI more than 29
- Former athletes (control group)
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
Asthma and airway hyperreactivity prevalence in swimmers
Time frame: 3 measurements in the year
1 secondary outcome
Airway inflammation and remodeling in swimmers
Time frame: 3 measurements in the year and a bronchial biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2008.
- Derived from this study: PubMed 30141830Bougault V, Odashiro P, Turmel J, Orain M, Laviolette M, Joubert P, Boulet LP. Changes in airway inflammation and remodelling in swimmers after quitting sport competition. Clin Exp Allergy. 2018 Dec;48(12):1748-1751. doi: 10.1111/cea.13257. Epub 2018 Sep 14. No abstract available.
- Derived from this study: PubMed 20363843Bougault V, Turmel J, Boulet LP. Bronchial challenges and respiratory symptoms in elite swimmers and winter sport athletes: Airway hyperresponsiveness in asthma: its measurement and clinical significance. Chest. 2010 Aug;138(2 Suppl):31S-37S. doi: 10.1378/chest.09-1689. Epub 2010 Apr 2.
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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.
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 Asthma and Airway Hyperresponsiveness, run by Laval University at 1 site in Canada.
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 3 inclusion and 5 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 22 Dec 2008. 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 Canada. 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 Valérie BOUGAULT, PhD (418-656-8711 ext. 1507, valerie.bougault@crhl.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma and airway hyperreactivity prevalence in swimmers (time frame: 3 measurements in the year). 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 NCT00686452, 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 22 Dec 2008.