bronchial asthma MedDRA version: 5.1 Level: llt Classification code 10003553
Conditions
Interventions
Trade Name: Alvesco 40 Inhaler
Product Name: Alvesco 40 Inhaler
Product Code: BY9010
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Ciclesonide
CAS Number: 126544-47-6
Cur
Sponsors
ALTANA Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female outpatients aged 12 to 75 years inclusive - written informed consent - history of bronchial asthma for at least 6 months - good health with the exception of asthma - treated with inhaled steroids with a maximum daily constant dosage of 250 µg fluticasone propionate or equivalent during the last 4 weeks di-rectly prior B0 - FEV1 = 80 - 105% of predicted Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a)Diseases and health status: - clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation - concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e. g. active pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment) - suffering from COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function, - current smoking with > 10 pack-years,· previous smoking with > 10 pack-years. b)Medication - use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times during the last 6 months - use of other drugs not allowed (see 7.4) - washout times of drugs defined under 7.4 cannot be adhered to - known or suspected hypersensitivity to inhaled steroids or to the other excipients of the MDIs - intolerance to salbutamol or to other excipients of the MDI - beginning of immunotherapy within the study period (exception: Pa-tients who are undergoing immunotherapy for at least 3 months are eligible provided the regimen remains the same throughout the trial). c) Common criteria: - pregnancy - intention to become pregnant during the course of the study - breast feeding - lack of safe contraception: Female patients of childbearing potential, not using and not will-ing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implant-able contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/ hysterectomized or post-menopausal > 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases - participation in another study within the 30 days preceding and during the present study - previous enrollment into the current study - enrollment of the investigator - known or suspected non-compliance, alcohol or drug abuse, - inability to follow the procedures of the study, e.g. due to language problems, psychological disorders - reversal of sleep pattern (e.g. night shift workers) - intention to relocate during the course of the study, preventing adherence to visit schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - to compare the efficacy of 80 µg ciclesonide od in the evening versus 100 µg fluticasone propionate bid on pulmonary function, time to first asthma exacerbation, asthma symptoms, use of rescue medication and quality of life in patients with mild to moderate asthma - to study the safety and tolerability of ciclesonide;Secondary Objective: ;Primary end point(s): - FEV1 | — |
Countries
Austria, Germany
Outcome results
None listed