Analyze the protective effect of intranasal corticosteroids against exercise induced upper and lower airway obstruction
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cold air exercise provocation test. Lungfunction will be determined with
spirometric and oscillometric measurements.
Secondary outcome
Asthma Controle Questionnaire by Juniper
Borg scale of dyspneoa
Background summary
Dyspnoea cause by exercise is a common problem in children with astma and is a
sign of airway hyperreactivity. Dyspnoea due to exercise is the most common
complaint in children with asthma. Exercise induced airway obstruction can
occur intra- and extra-thoracic.
Hyperreactivity in the upper airways is often the cause of allergic rhinitis or
gatro-oesophagal reflux. Hyperreactivity in the upper airways can be diminished
with a nasal steroid.
Study objective
Analyze the protective effect of intranasal corticosteroids against exercise
induced upper and lower airway obstruction
Study design
Children with exercise induced airway obstruction will continue in the study of
a double-blind, randomized, and placebo-controlled design. Children will
receive placebo or 27,5 *g Fluticasone furoatein each nostril for 4 weeks.
Intervention
Children will receive placebo or 27,5 *g Fluticasone furoate in each nostril
for 4 weeks.
Study burden and risks
The risk for patients has been estimated to be negligible.
Ariënsplein 1
7531 JX Enschede
Nederland
Ariënsplein 1
7531 JX Enschede
Nederland
Listed location countries
Age
Inclusion criteria
children (12-17 years) with a history allergic rhinitis and/or allergic asthma
able to perform lung-function
FEV1>70% of predicted
clinically stable for 3 weeks
Exclusion criteria
Use of nasal/systemic steroids
bronchodilators prior to test
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 | EUCTR2006-005875-16-NL |
| CCMO | NL15101.044.06 |