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 | 8.0 |
E.1.2 | Level | llt |
E.1.2 | Classification code | 10003555 |
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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 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· |
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E.2.2 | Secondary objectives of the trial |
To study the safety and tolerability of ciclesonide administered with and without spacer |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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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 investigation, · concomitant severe diseases or diseases which are contraindica-tions 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 impairment 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 lan-guage 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 |
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E.5 End points |
E.5.1 | 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 |
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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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Ciclesonide MDI with different spacer types vs Ciclesonide MDI without spacer |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 0 |
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 | 0 |