The study objective is to investigate in a placebo-controlled, double-blind manner the effect of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15 mannitol. Treatment medication will be administered as follows: 320 microgram ciclesonide or placebo will be inhaled once daily. The study duration consists of a treatment period of 4 weeks. The study will provide further data on safety of ciclesonide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
320µg Ciclesonide versus Placebo
Placebo
Nycomed
Basel, Switzerland
Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo
Time frame: 4 weeks
RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given)
Time frame: 4 weeks
Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment
Time frame: 4 weeks
Level of exhaled nitric oxide after 4 weeks of treatment
Time frame: 4 weeks
mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper)
Time frame: 4 weeks
Mean change of ACQ after 4 weeks of treatment
Time frame: 4 weeks
Mean change of AQLQ after 4 weeks of treatment
Time frame: 4 weeks
Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment
Time frame: 4 weeks
Exacerbation rates during the 4 weeks of treatment
Time frame: 4 weeks
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