Asthma
Conditions
Keywords
Asthma, Ciclesonide
Brief summary
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.
Interventions
DRUGCiclesonide
320µg Ciclesonide versus Placebo
DRUGPlacebo
Placebo
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Referred to the pulmonology department of the university hospital Basel because of suspected asthma defined as respiratory symptoms like wheezing or cough or chest tightness. 2. Asthma symptoms partly controlled according to GINA (October 2006) 1 week prior to randomization 3. FEV1 ≥ 70% predicted 4. 18 - 70 years old
Exclusion criteria
1. Smoker and ex-smoker with \>10 pack years 2. COPD 3. Upper respiratory tract infection within the past 4 weeks. 4. ICS or oral steroids during the previous month before inclusion 5. b-blockers within the past 4 weeks 6. Current treatment with medication as defined in section concomitant medication (ICS other than study medication, ß-blockers) 7. Pregnancy 8. Known malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment | 4 weeks |
| Level of exhaled nitric oxide after 4 weeks of treatment | 4 weeks |
| mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper) | 4 weeks |
| RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given) | 4 weeks |
| Mean change of AQLQ after 4 weeks of treatment | 4 weeks |
| Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment | 4 weeks |
| Exacerbation rates during the 4 weeks of treatment | 4 weeks |
| Mean change of ACQ after 4 weeks of treatment | 4 weeks |
Countries
Switzerland
Outcome results
None listed