Analyze the protective effect of levocetirizine (LEV), through the direct antagonism of airway H1 receptors and the inhibition of the release or production of other inflammatory mediators, against exercise induced airway obstruction.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The reduction in exercise induced fall of FEV1, MIF50 and increase in airway
resistance after a single dose of LEV.
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. EIAO is considered to be a
manifestation of airway hyperresponsiveness and highly specific for asthma in
children.
The exact mechanism of exercise induced bronchial obstruction (EIB) is not
known, however, two hypotheses have been proposed. Besides wheezing as a sign
of bronchial obstruction exercise may induce an inspiratory stridor, suggesting
an extra-thoracic airway obstruction.
Asthma and allergic rhinitis commonly coexist with histamine as a common
mediator. Antihistamines are widely used in the treatment of allergic rhinitis.
Histamine and other inflammatory mediators have been suggested to be involved
in EIB. However, pretreatment with specific H1-receptor antagonists has given
variable results. The effect of antihistamines on exercise induced
extra-thoracic airway obstruction (EIET) has not yet been studied.
The aim of the study is to investigate whether levocetirizine (LEV) protects
against airway obstruction after exercise.
Study objective
Analyze the protective effect of levocetirizine (LEV), through the direct
antagonism of airway H1 receptors and the inhibition of the release or
production of other inflammatory mediators, against exercise induced airway
obstruction.
Study design
This is an interventional-observational study
Intervention
Participants will receive a single dose of 5 mg LEV or placebo 4 hours prior to
performing an exercise challenge test. A week later they will receive the
opposed treatment.
Study burden and risks
Patients will have to undergo three exercise provocation challenges. Each of
these tests takes about 2 hours, for a total load of 6 hours. Especially in
children exercise limitation is a heavy burden on quality of life, however the
exercise challenges poses a minimal risk. The possible dyspnoea is comparable
to that experienced when exercising in real life.
Ariensplein 1
7511 JX Enschede
Nederland
Ariensplein 1
7511 JX Enschede
Nederland
Listed location countries
Age
Inclusion criteria
- 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.
Exclusion criteria
- 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 intranasal or systemic corticosteroids, antihistamines, cromoglycates, anticholinergics, during 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.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2007-005928-33-NL |
| CCMO | NL21454.000.08 |