Exercise Induced Bronchoconstriction
Conditions
Interventions
Trade Name: Beclomethason-diproprionaat (Qvar) autohaler dosisaerosol
Pharmaceutical Form: Inhalation vapour
Sponsors
Medisch Spectrum Twente
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Clinical history of asthma symptoms. - Age 6 through 16 years. - Documented EIB =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Exacerbation in the last 4 weeks prior to the ECT (hospital admission or use of systemic corticosteroids). - Use of long acting bronchodilators 24 hours before testing. - Use of short acting bronchodilators 8 hours before testing. - Use of leukotriene antagonists 24 hours before testing. - Use of oral/ nasal/inhaled corticosteroids < 2months prior to the study - Other pulmonary or cardiac disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of this study is to investigate if body posture influences effectiveness of a regular single dose of BDP (200µg) against EIB.;Primary end point(s): EIB as measured with FEV1 (or FEV0.5 if FEV1 is not repeatable) in relation to the body posture and head position during inhalation; standard or leaning forward with the head flexed backward. ;Secondary Objective: Secondary objectives are investigation if body posture and head position during medication inhalation influences inspiratory flow obstruction as measured with spirometry during and after an ECT in asthmatic children of > 12 years old. We also want to investigate which body postures children usually have during medication inhalation at home with the aid of a questionnaire. ;Timepoint(s) of evaluation of this end point: September 2013: recruiting children October 2013: start exercise challenge tests Time = 0: first exercise challenge test to include children who demonstrate a evident FEV0.5 or FEV1 fall. after 1 week and 2 weeks: second and third exercise challenge test with either a placebo four hours prior to the test or beclomethason dipropionate four hours prior to the test. March 2014: finishing exercise challenge tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secundary study parameters/outcome of the study: Inspiratory flow obstruction as measured with spirometry during and after an ECT in asthmatic children of > 12 years old in relation to body posture and head position during inhalation. Different body postures children usually have during medication inhalation at home with the aid of a questionnaire. ;Timepoint(s) of evaluation of this end point: September 2013: recruiting children October 2013: start exercise challenge tests Time = 0: first exercise challenge test to include children who demonstrate a evident FEV0.5 or FEV1 fall. after 1 week and 2 weeks: second and third exercise challenge test with either a placebo four hours prior to the test or beclomethason dipropionate four hours prior to the test. March 2014: finishing exercise challenge tests. | — |
Countries
Netherlands
Contacts
Public ContactInvestigator/Docter
Medisch Spectrum Twente
Outcome results
None listed