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 |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 <= 250 µg fluticasone propionate (or equivalent) per day only and at constant dosage during at least four weeks prior to entry in the study, the FEV1 has to be > 60% to < 80% of predicted when rescue medication has been withheld for at least 6 h. In patients pre-treated with <= 250 µg fluticasone propionate (or equivalent) per day in combination with:
- an inhaled LABA in a fixed or free combination, or - sustained-release theophylline, or - a leukotriene antagonist, or - a lipoxygenase inhibitor, or - an oral beta-agonist,
at constant dosage during at least four weeks prior to entry into the study, the FEV1 has to be >= 80% of predicted when rescue medication has been withheld for at least 6 h. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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) |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |