asthma bronchiale MedDRA version: 5.1 Level: llt Classification code 10003553
Conditions
Interventions
Product Name: Ciclesonide/Formoterol Fixed Combination
Product Code: BY9010
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Ciclesonide
CAS Number: 126544-47-6
Current Sponsor code: BY9010
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, - 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 60% to = 80% of predicted when rescue medication has been withheld for at least 6 h. Are the trial subjects under 18? no 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: - 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), or contraindications for the use of LABAs (e.g. diagnosis or history of significant cardiovascular diseases, insulin-dependent diabetes mellitus, uncontrolled hypertension, hyperthyroidism, thyrotoxicosis, phaeocromocytoma, hypokalaemia, prolonged QTc interval (male > 430 ms, female > 450 ms), or tachyarrhythmia), - suffering from chronic obstructive pulmonary disease (COPD) (i.e. chronic bronchitis or ephysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function (infection of lower airways within 4 weeks prior to entry into the study), - clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (e.g. abnormal serum potassium and glucose levels), - current smoking,· - previous smoking with a smoking history >= 10 cigarette pack-years, where "previous smoking" is defined as abstinence from smoking for a minimum of six months - use of injectable or oral systemic steroids within 2 months prior to entry into the study, or more than 3 courses during the last 6 months, - use of other prohibited drugs and washout times of prohibited drugs cannot be adhered to, - known or suspected hypersensitivity to ICS, to formoterol, to the excipient lactose monohydrate, or to other excipients of the DPI, - known or suspected hypersensitivity to salbutamol or to excipients of the metered dose inhaler (MDI), - beginning of immunotherapy within the study period, - pre-treatment with variable doses of ICS, either alone or in combination with a non-steroidal controller, during the last 4 weeks prior to baseline, - pregnancy, - intention to become pregnant during the course of the study, - breast feeding, - 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 his/her employees, - reversal of sleep pattern (e.g. night shift workers), - inability to follow the procedures of the study; e.g. due to language problems, psychological disorders, - known or suspected non-compliance, alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the efficacy of a fixed combination of ciclesonide and formoterol administered once daily in the morning. The efficacy of morning dosing will be assessed by comparing the fixed combination administered once daily in the morning with - ciclesonide monotherapy, administered once daily in the morning, - a fixed combination of ciclesonide and formoterol, administered twice daily, and - placebo, in patients with persistent asthma.;Secondary Objective: The secondary objective is to assess the efficacy of evening dosing, which will be assessed by comparing the fixed combination administered once daily in the evening with - ciclesonide monotherapy, administered once daily in the evening, - a fixed combination of ciclesonide and formoterol, administered twice daily, and - placebo, in patients with persistent asthma. Additionally, the efficacy of combination therapy administered in the morning will be compared with combination therapy administered in the evening, as the time of administration can also influence the efficacy of the study drug. A further objective is to study the safety and tolerability of the fixed combination of ciclesonide and formoterol.;Primary end point(s): Primary variable (referring to the primary comparisons involving a.m. administration): - morning PEF from diaries (last week compared to week 0) Key secondary variables: - proportion of days on which patient perceived asthma control (i.e., proportion of symptom-free and rescue medication-free days) in case of comparisons involving a.m. administration: - morning FEV1 from measurements at the investigational site (last value compared to T0) in case of comparisons involving p.m. administration: - evening PEF from diaries (last week compared to week 0) - evening FEV1 from diaries (last week compared to week 0) | — |
Countries
Czech Republic, Hungary
Outcome results
None listed