asthma bronchial MedDRA version: 8.0 Level: llt Classification code 10003555
Conditions
Interventions
Trade Name: Alvesco 160
Product Name: Alvesco 160
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Ciclesonide
CAS Number: 126544-47-6
Current Sponsor code: BY9010
Concentrat
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 persistent bronchial asthma (as defined by GINA 2004) for at least 6 months, · good health with the exception of asthma, · currently treated with - either rescue medication only i.e. short-acting beta-agonists (either as monotherapy or as a fixed combination with an anticholinergic), or long-acting beta-agonists, -or with inhaled steroids with a maximum daily dosage of 250 µg fluticasone propionate or equivalent - or with other anti-inflammatory asthma drugs than inhaled steroids, i.e. leukotriene antagonists, xanthine derivates, inhaled cromones, lipoxygenase inhibitors, - or with a fixed or concurrent combination of an inhaled steroid (up to 125µg/day FP or equivalent) and a long-acting ß-agonist or other asthma controllers at a constant dose for the last 4 weeks directly prior to baseline. · FEV1 must meet one of the following rules: - either FEV1=61 - 90% of predicted in patients treated with rescue medication only, - or FEV1=81 - 105% of predicted in patients treated with inhaled steroids alone or in combination with a long-acting ß-agonist or other asthma controller, - or FEV1=61 - 105% in patients treated with other anti-inflammatory asthma drugs than inhaled steroids. FEV1 and FVC have to be measured at least 4 hours after the last use of short-acting beta-agonists and fixed combinations of short-acting beta-agonists and anticholinergics and at least 24 hours after the last use of long-acting beta-agonists. 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: Diseases and health status: · clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation, · concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e. g. active or inactive 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 impair-ment in pulmonary function, · smoking history with = 10 cigarette pack-years (= 2 pipe pack-years) Medication: · use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months, · treatment with inhaled steroids - in dosages higher than listed in the inclusion criteria, - or fluctuating doses of ICS during the 4 weeks directly prior to baseline · use of other drugs not allowed, · washout times of drugs cannot be adhered to, · known or suspected hypersensitivity to inhaled steroids or to the other excipients of the MDI, · intolerance to salbutamol or to other excipients of the MDI, · beginning of immunotherapy during the patient´s participation in the study, or having begun an immunotherapy less than three months prior to enrolment, or alternation in regimen of an immunotherapy during the study period. Common criteria: · pregnancy, · intention to become pregnant during the course of the study, · breast feeding, · lack of safe contraception, · 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, employees and other dependent persons, · 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 160 µg ciclesonide administered od pm with or without different spacer types on pulmonary function and other variables of asthma control· ;Secondary Objective: To study the safety and tolerability of ciclesonide administered with and without spacer;Primary end point(s): Primary efficacy variable: · FEV1 (Tend/Tlast, compared to T0) Secondary efficacy variables: · FEV1 (treatment visits compared to T0), · FVC (Tend/Tlast; treatment visits compared to T0), · Morning and evening PEF from diaries (Wend/Wlast and weekly averages compared to W0), · Asthma symptom score (daytime, nighttime, total; Wend/Wlast and weekly averages compared to W0), · Use of rescue medication (Wend/Wlast and weekly averages compared to W0), · Number of patients with an asthma exacerbation, · Time to the first asthma exacerbation, · Percentage of days on which patient perceived asthma control, · Percentage of nocturnal awakening-free days, · Percentage of rescue medication-free days, · Percentage of asthma symptom-free days. Safety variables: · Adverse events, · Physical examination, · Vital signs, · Standard laboratory work-up, · 8 am serum cortisol | — |
Countries
Germany, Hungary, Italy
Outcome results
None listed