Asthma Respiratory Asthma
Conditions
Interventions
Drug: Ciclesonide
Sponsors
Altana Pharma B.V. (The Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria: 1. History of bronchial asthma 2. Forced Expiratory Volume in once second (FEV1) more than 1.20 L 3. Positive skin prick test 4. Not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit
Exclusion criteria
Exclusion criteria: Main exclusion criteria: 1. Clinically relevant abnormal laboratory values 2. Concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids 3. Chronic Obstructive Pulmonary Disease (COPD) and /or other relevant lung diseases 4. One asthma exacerbation within two months or more than three exacerbations within the last year prior to baseline visit 5. Current smokers or ex-smokers with more than ten pack years, or having smoked within one year prior to baseline visit 6. Positive response to saline challenge at baseline visits 7. Positive bronchial hyperresponsiveness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PC20 (AMP) (Post?treatment compared to baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ? (Forced Vital Capacity [FVC]/Slow Vital Capacity [SVC]) at PC20 (AMP). 2. Safety and tolerability. | — |
Countries
Netherlands
Outcome results
None listed