To analyze the protective effect of azelastine/fluticasone propionate against exercise-induced airway narrowing by measuring inspiratory and expiratory airflow limitation and airway resistance and reactance in asthmatic children.
ID
Source
Brief title
Condition
- Other condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Health condition
bovenste luchtwegaandoeningen, allergische rhinitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Analyze the reduction in exercise-induced fall in FEV1 after three weeks of
treatment with azelastine/fluticasone propionate in comparison with a placebo.
-Analyze the reduction in exercise-induced fall in MIF50 after three weeks of
treatment with azelastine/fluticasone propionate in comparison with a placebo.
Secondary outcome
-Analyze the reduction in exercise-induced increase of airway resistance at low
frequency, measured with FOT, after three weeks of treatment with
azelastine/fluticasone propionate in comparison with a placebo.
-Analyze the reduction in exercise-induced decrease of airway reactance at low
frequency, measured with FOT, after three weeks of treatment with
azelastine/fluticasone propionate in comparison with a placebo.
-Analyze the increase in quality of life, measured with the pediatric asthma
quality of life questionnaire (PAQLQ), after three weeks of treatment with
azelastine/fluticasone propionate in comparison with a placebo.
-Analyze the increase in control of asthma, measured with the asthma control
test (ACT), after three weeks of treatment with azelastine/fluticasone
propionate in comparison with a placebo
Background summary
Exercise-induced airway obstruction (EIAO) is an acute, reversible bronchial
obstruction occurring after of during physical exercise (1). It classically
limits expiratory airflow and is then referred to as exercise-induced
bronchoconstriction (EIB). However, to a certain degree most children also
display inspiratory airflow limitation. EIAO is highly prevalent in children
with asthma and a frustrating morbidity. It reflects active inflammation of the
airways and is a sign of uncontrolled asthma. It is associated with atopy and
considered to be a manifestation of airway hyperresponsiveness (AHR). AHR is
the term commonly used to identify how fast and to which degree airway
obstruction occurs due to a variety of stimuli, such as exercise.
Allergic rhinitis is a frequent co-morbidity of childhood asthma and an
uncontrolled allergic rhinitis can deteriorate existing pulmonary problems.
Intra-nasal corticosteroids are effective against allergic rhinitis and reduce
EIB in asthmatic children. The exact mechanisms underlying the effect of nasal
steroids on EIB are unclear. In this study, we want to investigate the
potential effect of azelastine/fluticasone proprionate against exercise-induced
changes in asthmatic children.
Study objective
To analyze the protective effect of azelastine/fluticasone propionate against
exercise-induced airway narrowing by measuring inspiratory and expiratory
airflow limitation and airway resistance and reactance in asthmatic children.
Study design
This prospective study is of a double-blind, randomized, and placebo-controlled
design.
To increase the power for the interim analysis, 10 patients will be included in
the Dymista group. These patients will receive the same information as the
other patients, namely that they participate in an RCT and can receive either
Dymista or a placebo, thereby influencing these 10 tests as little as possible.
The long function physician that performs these tests is also not informed that
these 10 patients all receive Dymista (and not a placebo) to influence these
tests as little as possible.
Intervention
Participants in the intervention group will receive 1 puff
azelastine/fluticasone propionate twice a day in each nostril. Participants in
the control group will receive a placebo.
Study burden and risks
Patients will undergo two ECT*s. Each of these tests takes about 1 hour, for a
total load of 2 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 daily life.
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
Inclusion criteria
- Clinical history of allergic rhinitis and EIB
- Age between 12 and 18 years.
- Ability to perform spirometry and FOT
Exclusion criteria
- Other pulmonary or cardiac illnesses
- Severe EIB i.e. a fall of >=40% FEV1 in the first ECT, requiring an acute
change in maintenance medication (standard care)
- 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 the last 4 weeks
- Use of intranasal or systemic corticosteroids in the last 4 weeks prior to
the study.
- Use of antihistamines, cromoglycates, anticholinergics in two weeks prior the
study or during the study.
- Other changes in asthma medication during treatment period
- 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 | EUCTR2018-001120-18-NL |
| CCMO | NL65451.044.18 |