asthma MedDRA version: 5.1 Level: llt Classification code 10003553
Conditions
Interventions
Trade Name: ALVESCO 160 Inhaler
Product Name: Alvesco 160 Inhaler
Product Code: BY9010
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Ciclesonide
CAS Number: 126544-47-6
C
Sponsors
ALTANA Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Written informed consent -Male or female outpatient aged 18 to 75 years inclusive -History of bronchial asthma for at least 6 months as defined by ATS criteria -Good health with the exception of asthmaAsthma Treatment: -Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) > = 1000 µg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination. The doses of this pre-treatment has to be kept constant for at least 8 weeks directly prior to visit B0 Note: This treatment will be continued during the baseline period. All other anti-asthma medication has to be stopped at visit B0. Pulmonary function: -FEV1 > = 80 % of predicted measured at least 4h after the last use of short-acting beta-agonists and at least 12 h after the last use of oral and inhaled LABAs and other anti-asthma medications. Asthma symptoms (based on investigator assessment and on patient’s reporting): -Symptoms less than once a week, and -nocturnal symptoms no more than twice a month and only -occasional use of inhaled short-acting ß-agonists 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: 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), or contraindications for the use of LABAs -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 (> = 2 pipe pack years) -previous smoking with > = 10 pack-years (> = 2 pipe pack years) b) Medications: -use of systemic steroids during the 4 weeks (injectable depot steroids during the 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months -use of other drugs not allowed -washout times of drugs as defined in the study protocol cannot be adhered to known or suspected hypersensitivity to inhaled steroids or to the other excipients of the MDIs -intolerance to salbutamol or formoterol or to the other excipients of the devices -beginning of immunotherapy within the study period (exception: Pa-tients who are undergoing immunotherapy for at least 3 months prior to B0 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 -participation in another study within the 30 days preceding and during the present study -previous enrollment into the current study -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 study and compare safety and tolerability of ciclesonide (CIC 320 µg ex mouthpiece, twice daily in the morning and evening) versus flu-ticasone propionate (FP 500 µg ex valve, twice daily in the morning and evening) regarding candidiasis of the oropharynx and/or hoarse-ness in patients with moderate and severe well controlled persistent asthma· To study and compare efficacy of ciclesonide (CIC 320 µg ex mouth-piece (i.e. 400 µg CIC ex valve), twice daily in the morning and evening) versus fluticasone propionate (FP 500 µg ex valve, twice daily in the morning and eve-ning) regarding pulmonary function, asthma symptoms and use of res-cue medication To study additional safety and tolerability aspects of ciclesonide ;Secondary Objective: ;Primary end point(s): Number of patients with candidiasis of the oropharynx and / or hoarseness # #Note that only the first occurrence of candidiasis of the oropharynx and hoarseness, respectively will be taken into account | — |
Countries
Italy, United Kingdom
Outcome results
None listed