Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101)
Asthma

About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Quality of Life, Ciclesonide
Eligibility Criteria
Main Inclusion Criteria: Written informed consent Good health with the exception of asthma Clinical diagnosis of moderate persistent asthma during the last 6 months prior to visit B0 Pre-treatment with inhaled corticosteroids dose equivalent to 250 - 500 mcg BDP / day at stable dosing during the last 4 weeks prior to visit B0, concomitant or not to short-acting beta2-agonists treatment as rescue medication FEV1 ≥ 70% and ≤ 90% predicted measured at least 4 h after the last use of rescue medication at visit B0 Reversibility ≥ 12% and ≥ 200 mL in B0, B0 or T0, after inhalation of 400 mcg of salbutamol Patients compliant to recommended pre-treatment Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids Chronic obstructive pulmonary disease (COPD) Hospitalization within previous four weeks from baseline Hospitalization due to asthma within the last twelve months Asthma exacerbation within two months previous to baseline History of almost fatal asthma at any moment Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women Exacerbation of asthma within 2 months prior to entry into the baseline period Use of systemic steroids up to 2 months (injectable depot steroids 6 months) before entry into the baseline period, or more than 3 times during the last 6 months
Sites / Locations
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1
2
Ciclesonide 160µg
Ciclesonide 320µg