What is the correlation between change in % fall in FEV1 (*FEV1) after an exercise challenge 20h after a single dose of montelukast and after 4 weeks of treatment with montelukast?
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation between change in ΔFEV1 after a single dose of montelukast and
after 4 weeks of treatment with montelukast.
Secondary outcome
The predictive value for a response to montelukast after 4 weeks of treatment
(defined as ΔFEV1 < 15%) of:
- baseline FEV1
- symptom score on ACT
- IgE
- positive RAST test
Background summary
Asthma is a heterogeneous disease and clinical phenotypes are highly variable.
This is exemplified in the variability of patients* responses to medications
such as montelukast. It is a critical clinical question whether a particular
therapy will be effective in an individual child with symptoms of asthma. At
the moment, there is a lack of diagnostic tools to assess this individual
responsiveness.
Montelukast is a leukotriene receptor antagonist (LTRA) used as prophylaxis for
exercise induced bronchoconstriction (EIB). EIB occurs in the majority of
asthmatic children and is a reflection of airway hyperresponsiveness (AHR). A
single dose of montelukast provides significant protection against EIB as soon
as 2 hours after dosing. This rapid response shows variability similar to the
variable responsiveness observed in long term treatment. We hypothesized that
the effect of a single dose of montelukast on EIB could predict the effect of
long term therapy with montelukast on EIB.
Study objective
What is the correlation between change in % fall in FEV1 (*FEV1) after an
exercise challenge 20h after a single dose of montelukast and after 4 weeks of
treatment with montelukast?
Study design
study is of a prospective, open-label design without a control group.
Intervention
All children will be treated with montelukast 5 mg (children aged 12-14 years)
or 10 mg (children aged >= 15 years) once daily for 4 weeks.
Study burden and risks
EIB is an entity that occurs in most children with asthma and has a great
influence on their quality of life. Adults usually perform planned exercise and
can take a short acting bronchodilator agent as prophylaxis. Children more
often perform exercise that wasn't planned in advance and therefore do not
always use prophylactic inhalation therapy. Prophylactic maintenance therapy
such as montlukast is therefore more useful in children. We expect treatment
with montelukast will improve pulmonary function, decrease symptom scores and
diminishes *FEV1 after exercise. Side effects of montelukast are usually mild.
Children will perform an Asthma Control Questionnaire and 3 exercise
challenges. An exercise challenge can cause serious dyspnoea. However, children
with EIB experience this every time they perform exercise and generally
consider this as a minimal burden.
Haaksbergerstraat 55
7500 KA Enschede
NL
Haaksbergerstraat 55
7500 KA Enschede
NL
Listed location countries
Age
Inclusion criteria
- Age between 12-18 years
- Clinical history of allergic asthma and exercise induced bronchoconstriction
- Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%
- Ability to run on a treadmill for 8 minutes
- Maximal FEV1 > 70% of predicted value
Exclusion criteria
- Other pulmonary or cardiac illnesses
- Maximal FEV1 < 70% of predicted value
- Use of systemic corticosteroids, antihistamines, cromoglycates, anticholinergics in two weeks prior to or during the study
- Use of long acting bronchodilator agents 24 hours before testing
- Use of short acting bronchodilator agents 8 hours before testing
- Hospitalization due to asthma exacerbation in past month
- Other changes in asthma medication during treatment period
- Upper or lower respiratory tract infections during treatment period
- Deviation of the FEV1 before the subsequent exercise challenges of more than 12 % from baseline FEV1
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 | EUCTR2009-016904-21-NL |
| CCMO | NL30374.044.09 |