Analyze the protective effect of fluticasone furoate, through reduction of allergic rhinitis, against exercise induced airway obstruction.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Analyze the reduction in exercise induced fall of FEV1 and MIF50 after three
weeks of treatment with fluticasone furoate.
Secondary outcome
•Analyze the reduction in exercise induced increase of airway resistance,
measured with the FOT, after three weeks of treatment with fluticasone furoate.
•Analyze the reduction in exercise induced decrease of airway reactance,
measured with the FOT, after three weeks of treatment with fluticasone furoate.
•Analyze the reduction in FeNO, measured with the FOT, after three weeks of
treatment with fluticasone furoate.
•Analyze the increase in quality of life, measured with the PAQLQ, after three
weeks of treatment with fluticasone furoate.
•Analyze the increase in control of asthma, measured with the ACQ, after three
weeks of treatment with fluticasone furoate.
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 is especially in childhood a frustrating morbidity. EIAO is considered to
be a manifestation of airway hyperresponsiveness and highly specific for asthma
in children. EIAO can therefore be considered a sign of not well controlled
asthma. Asthma control can be determined by using an asthma control
questionnaire by Juniper
Besides wheezing as a sign of bronchial obstruction, exercise may induce an
inspiratory stridor, suggesting an extra-thoracic airway obstruction. Allergic
rhinitis and gastro-esophageal reflux can cause and sustain extra-thoracic
hyperresponsiveness. The aim of the study is to investigate whether treatment
of allergic rhinitis with a intra-nasal corticosteroids protects against airway
obstruction after exercise.
Study objective
Analyze the protective effect of fluticasone furoate, through reduction of
allergic rhinitis, against exercise induced airway obstruction.
Study design
Double-blind, randomized, and placebo-controlled prospective study.
Intervention
In the first week, participants will receive 2 puffs of 27,5 micrograms
fluticasone furoate in each nostril daily to start treatment. The next 2 weeks
the participants will receive 1 puff daily in each nostril. In patients who
drew placebo, fluticasone furoate is replaced by placebo.
Study burden and risks
Patients will have to undergo two exercise provocation challenges. Each of
these tests takes about 2 hours, for a total load of 4 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.
Haaksbergerstraat 55
7513 ER Enschede
Nederland
Haaksbergerstraat 55
7513 ER Enschede
Nederland
Listed location countries
Age
Inclusion criteria
Children (12-17 years) with a history of allergic asthma
Able to perform reproducible lung function tests
FEV1>70% of predicted
Clinically stable for 3 weeks
Exclusion criteria
Use of nasal/systemic steroids
Use of bronchodilators before testing
Other cardiac or pulmonary disease
Signs of gastro-oesophagal 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 | EUCTR2009-010563-17-NL |
| ISRCTN | ISRCTN90761040 |
| CCMO | NL26953.044.09 |