E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 5.1 |
E.1.2 | Level | llt |
E.1.2 | Classification code | 10003553 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
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E.4 | Principal 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) |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |