Analyze the correlation between change in EELV with change in MIF50
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study endpoint will be the end of the exercise provocation test, where
change in MIF50 will be linked to change in EELV.
Secondary outcome
not applicable
Background summary
Exercise induced airway obstruction (EIAO) is defined as an acute, reversible
bronchial obstruction occurring immediately after and occasionally during
physical exercise. EIAO is highly prevalent in adults and children with asthma
and especially in childhood an invalidating entity. Besides wheezing as a sign
of bronchial obstruction, exercise may induce an inspiratory stridor,
suggesting an extra-thoracic airway obstruction. Extra-thoracic airway
obstruction has been reported in response to pharmacological and physical
challenges with or without bronchial obstruction. Extra-thoracic airway
obstruction can be measured with a drop of more then 25% of the forced
mid-inspiratory flow (MIF50).
In exercise, as the exercise load increases, tidal volume increases and end
expiratory lung volume (EELV) decreases. Asthmatics, despite having end
expiratory flow limitation do not show and increase in EELV. This may be due to
inspiratory flow limitation, caused by extra-thoracic airway obstruction. The
aim of the study is to investigate the effect of exercise induced
extra-thoracic airway obstruction (EIET) on EELV in asthmatic and healthy
children.
Study objective
Analyze the correlation between change in EELV with change in MIF50
Study design
This is a observational study design with a non-medicinal intervention
Intervention
2 exercise provocation tests.
Study burden and risks
Patients will have to undergo two subsequent exercise provocation challenges.
These challenges will be in one session, which will take approximately 2 hours.
Especially in children exercise limitation is a heavy burden on quality of
life, however the exercise challenges pose a minimal risk. The possible
dyspnoea is comparable to that experienced when exercising in real life.
Ariënsplein 1
7531 JX Enschede
Nederland
Ariënsplein 1
7531 JX Enschede
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria (asthmatic subjects)
- Clinical history of allergic rhinitis and/or allergic asthma.
- Age between 12 and 17 years.
- Ability to perform reproducible lung function tests, i.e. coefficient of the predicted
value variation in 3 of 5 consecutive measurements < 5%.
- Maximal FEV1 greater than 70% of predicted value.
- Clinically stable period at least 3 weeks before the study period. ;Inclusion criteria (healthy subjects)
- No currently reported illnesses.
- Age between 12 and 17 years.
- Ability to perform reproducible lung function tests, i.e. coefficient of the predicted
value variation in 3 of 5 consecutive measurements < 5%.
- Maximal FEV1 greater than 70% of predicted value.
- Clinically stable period at least 3 weeks before the study period.
Exclusion criteria
Exclusion criteria (asthmatic subjects)
- Use of intranasal or systemic corticosteroids in the last 4 weeks prior to the study.
- Use of antihistamines, cromoglycates, anticholinergics in two weeks prior to the study.
- Use of long acting bronchodilators 24 hours before testing.
- Use of short acting bronchodilators 8 hours before testing.
- Other pulmonary or cardiac disorder.
- Deviation of the FEV1 of more than 12 % from baseline spirometry and the FEV1 before subsequent exercise provocation challenges.
- Signs of gastro-esophageal reflux. ;Exclusion criteria (healthy subjects)
- Reported Illness in the past.
- Exhaled NO of more than 20 ppb
- Signs of gastro-esophageal reflux.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL20789.000.07 |