What is the correlation between change in Mannitol PD15 (provoking dose of mannitol to cause a >= 15% fall in FEV1 ) 6h after a single dose of beclomethasone and after 4 weeks of treatment with beclomethasone?
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation between change in Mannitol PD15 after a single dose of
beclomethasone and after 4 weeks of treatment with beclomethasone.
Secondary outcome
Which individual patient and disease characteristics are confounders for this
correlation?
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 beclomethasone. 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.
Beclomethasone 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 beclomethasone on a BPT (a mannitol challenge) could
predict the effect of longterm therapy with beclomethasone on BHR.
Study objective
What is the correlation between change in Mannitol PD15 (provoking dose of
mannitol to cause a >= 15% fall in FEV1 ) 6h after a single dose of
beclomethasone and after 4 weeks of treatment with beclomethasone?
Study design
This study is of a prospective, open-label design.
Intervention
All children are treated with beclomethasone 100µg or 200µg twice daily for 4
weeks.
Study burden and risks
Mannitol can mimic the airway response to exercise by influencing the
osmolarity of the airway surface liquid and is used as an indirect BPT to
diagnose and monitor BHR to exercise (EIB). EIB occurs in the majority of
asthmatic children and has a great influence on their quality of life.1 Adults
usually perform planned exercise and can take a short acting bronchodilator
agent as prophylaxis. 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.2
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.2,3
We expect treatment with beclomethasone will improve pulmonary function,
decrease symptom scores and diminish bronchial hyperresponsiveness. Side
effects of beclomethasone are usually mild. Children will perform an Asthma
Control Questionnaire and 3 mannitol challenges. A mannitol challenge can cause
some dyspnoea, but ends when a >15% fall in FEV1 occurs. Furthermore, a
mannitol challenge can cause some transient coughing.
haaksbergerstraat 55
Enschede 7500KA
NL
haaksbergerstraat 55
Enschede 7500KA
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 (predicted value variation in 3 of 5 consecutive measurements < 5%)
- Maximal FEV1 > 70% of predicted value
Exclusion criteria
- Other pulmonary or cardiac illnesses
- Maximal FEV1 < 70% of predicted value
- Use of nasal or systemic 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
- Deviation of the FEV1 before the subsequent mannitol 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 | EUCTR2010-018937-23-NL |
| CCMO | NL31940.044.10 |