Trial record 16 of 33 for:    "Asthma, Exercise-Induced"

Study of Airway Inflammation in Relation to Exercise in Elite Athletes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dominque Bullens, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01942096
First received: August 26, 2013
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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.


Condition
Exercise Induced Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Airway Inflammation in Relation to Exercise in Elite Athletes

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Measurement of airway inflammation [ Time Frame: Baseline, immediately after and 24 hours after sport-specific training ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Measurement of exercise induced bronchoconstriction [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Exercise induced bronchoconstriction will be assessed by eucapnic voluntary hyperventilation test.


Other Outcome Measures:
  • Detection of allergy [ Time Frame: baseline ] [ Designated as safety issue: No ]
    -Allergy will be assessed by skin prick test (on skin) and immunocap test (in blood, 1 tube of 10 ml).

  • Assessment of upper and lower airway symptoms [ Time Frame: Baseline, immediately after and 24 hours after sport-specific training ] [ Designated as safety issue: No ]
    -Upper and lower airway symptoms will be assessed by questionnaires (SinoNasal Outcome Measure-22, Visual Analogue Score, Asthma Symptom Score and Juniper Score)

  • Measurement of lung function and nasal patency [ Time Frame: at baseline, immediately after and 24 hours sport-specific training ] [ Designated as safety issue: No ]
    -Lung function and nasal patency will be measured by spirometry and Peak Nasal Inspiratory Flow measurement.


Biospecimen Retention:   Samples With DNA

induced sputum sample nasal fluid venous blood (serum)


Enrollment: 66
Study Start Date: December 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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)
  Eligibility

Ages Eligible for Study:   14 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Competitive swimmers, competitive indoor athletes and healthy individuals

Criteria

Inclusion Criteria:

  • Performing sports at national or international level (swimmers and indoor athletes)

Exclusion Criteria:

  • Performing sport at recreational level (not more than 4 hours/week for healthy individuals)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942096

Locations
Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Study Director: Sven F Seys, MSc lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven
Study Director: Valerie Hox, MD lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven
  More Information

No publications provided

Responsible Party: Dominque Bullens, prof dr, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01942096     History of Changes
Other Study ID Numbers: ML7650
Study First Received: August 26, 2013
Last Updated: September 9, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Asthma, Exercise-Induced
Inflammation
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014