asthma bronchiale MedDRA version: 5.1 Level: llt Classification code 10003553
Conditions
Sponsors
ALTANA Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent - Male or female outpatients - Age 18 to 75 years - History of bronchial asthma for at least 6 months - Patients, who are in good health with the exception of asthma Depending on the individual pre-treatment, additionally, one of the following criteria must be met at B0: - In patients pre-treated with 200 - 250 µg fluticasone propionate (or equivalent) per day as monotherapy and at constant dosage during at least four weeks prior to entry into the study, the FEV1 has to be > 60% to 60% to =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 (e.g. abnormal serum potassium and glucose levels) suggesting an unknown disease and requiring further clinical evaluation, · Concomitant severe diseases or diseases which are contraindications for the use of inhaled corticosteroids (ICS) (e.g. active and inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment), or contraindications for the use of long-acting beta2-agonists (LABAs, e.g. di-agnosis or history of significant cardiovascular diseases, insulin-dependent diabetes mellitus, uncontrolled hypertension, hyperthyroidism, thyrotoxicosis, phaeochromocytoma, hypokalaemia, prolonged QTc interval (male > 430 ms, female > 450 ms) or tachyarrhythmia), · Suffering from chronic obstructive pulmonary disease (COPD) (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function (e.g. infection of lower airways within 4 weeks prior to entry into the study), · Current smoking or cessation of smoking within the last 6 months, · Previous smoking with a smoking history > or = 10 cigarette pack-years, · More than one in-patient hospitalization or emergency care visit due to asthma exacerbations in the past year before B0 b) Medications: · Use of injectable corticosteroids or oral systemic corticosteroids within 2 months prior to entry into the study, or more than 3 courses during the last 6 months, · Use of other drugs not allowed and washout times of prohibited drugs cannot be adhered to, · Known or suspected hypersensitivity to ICS, formoterol, lactose monohydrate or to other excipients of the DPI, · Known or suspected hypersensitivity to salbutamol or to excipients of the MDI, · Beginning of immunotherapy within the study period, · Pre-treatment with variable doses of ICS, either as monotherapy or in combination with a non-steroidal controller, during the last 4 weeks prior to entry into baseline period, c) Common criteria: · Pregnancy or intention to become pregnant during the course of the study, breast feeding, or lack of safe contraception in women of child-bearing potential, · Participation in another study within the 30 days preceding and during the present study, · Previous enrolment into the current study, · Enrolment of the investigator, his/her family members or employees at the investigational site, · 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - to compare the effect of the two combinations of ciclesonide (320 µg/day) and formoterol (9 µg/day or 18 µg/day) administered once daily in the evening versus monotherapy of formoterol (18 µg od in the evening) on time to first experience of lack of efficacy (LOE) - to estimate the effect sizes for the comparisons of two combinations of ciclesonide (320 µg/day) and formoterol (9 µg/day or 18 µg/day) administered once daily in the evening versus monotherapy of ciclesonide (320 µg od in the evening) and monotherapy of formoterol (18 µg od in the evening) with regard to 24 h serial measurements of pulmonary function as well as trough FEV1 ;Secondary Objective: - the safety and tolerability of 8-week treatment with a fixed combination of ciclesonide and formoterol administered od in the evening in comparison to monotherapy with either formoterol or ciclesonide, e.g. by assessing adverse events, physical exami-nations, ECG and vital signs;Primary end point(s): Variables of primary interest: · Time to the first experience of LOE, · Difference in time-averaged AUC (FEV1) over a 24 h dosing interval after 2 weeks of treatment versus the reference profile at visit T0 (based on serial measurements), · Difference in trough FEV1 (more precisely, FEV1 prior to the dose of the 24 h profile, after 2 weeks of treatment compared to FEV1 at the beginning of the 24 h profile at visit T0), | — |
Countries
Germany, Hungary
Outcome results
None listed