This study aims to investigate if there is a correlation between the severity of bronchoconstriction after an exercise challenge test 6h after a single dose of Qvar and after 4 weeks of treatment with Qvar, in order to know if the respons to a…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation between the difference in fall in FEV1 after a single dose of Qvar
and after 4 weeks of treatment with Qvar.
Secondary outcome
na
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 Qvar. 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.
Qvar is an inhaled corticosteroid (ICS) used as controller therapy in children
with asthma, providing protection
against bronchial hyperresponsiveness (BHR) and exercise induced
bronchoconstriction (EIB). A single dose of an ICS can have a significant
effect on BHR measured by a bronchial provocation test (BPT). This rapid
response shows variability similar to the
variable responsiveness to long term treatment. We hypothesized that the effect
of a single dose of Qvar on a BPT (an exercise-challenge test) could predict
the effect of longterm therapy with Qvar on BHR.
Study objective
This study aims to investigate if there is a correlation between the severity
of bronchoconstriction after an exercise challenge test 6h after a single dose
of Qvar and after 4 weeks of treatment with Qvar, in order to know if the
respons to a single dose of Qvar can predict individual response on the longer
term.What
Study design
This study is of a prospective, open-label design.
Intervention
All children are treated with Qvar 100µg twice daily for 4 weeks.
Study burden and risks
This study is conducted in children because the burden of EIB is large in
childhood and there are substantial differences in the
pathofysiology of EIB between adults and children. Children more often perform
spontaneous exercise and therefore do not always use prophylactic inhalation
therapy.
Prophylactic maintenance therapy is therefore more widely used in children than
in adults. We expect treatment with Qvar will improve pulmonary function,
decrease symptom scores and diminish bronchial hyperresponsiveness. Side
effects of Qvar are usually mild. Children will fill in an Asthma Control Test
and will perform 2 exercise challenge tests. An exercise challenge test can
cause dyspnea, for which Salbutamol will be given. The amount of dyspnea is
comparable with the dyspnea that children experience during daily exercise. In
general, children don't experience the exercise challenge tests as strenuous.
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
Inclusion criteria
- Age between 12-18 years
- Clinical history of asthma and exercise induced bronchoconstriction
- Ability to perform an exercise-challenge test
- Maximal FEV1 > 70% of predicted value
Exclusion criteria
- Other pulmonary or cardiac illnesses
- Use of nasal or systemic or inhalation corticosteroids, antihistamines, cromoglycates, anticholinergics or leukotriene
antagonists 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
- Severe EIB i.e. a fall of >=40% FEV1 in the first ECT, requiring an acute change in maintenance medication
(standard care)
- Insufficient knowledge of the Dutch language
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 | EUCTR2016-002276-27-NL |
CCMO | NL58024.044.16 |
Other | trial register, nummer volgt |