E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 |
|
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 |
Pilot study to assess the efficacy of a fixed combination of ciclesonide and formoterol in comparison to a fixed combination of fluticasone and salmeterol, both administered twice daily (bid) by dry powder inhalers (DPI), in patients with persistent asthma bronchiale. |
|
E.2.2 | Secondary objectives of the trial |
Additionally, the study will provide further data on the safety and tolerability of a fixed combination of ciclesonide and formoterol. |
|
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 12 to 75 years - History of bronchial asthma for at least 6 months - Patients, who are in good health with the exception of asthma, and who have - FEV1 > 60% to < 80% of predicted, when rescue medication has been withheld for at least 6 h before pulmonary function measurement. This applies to all eligible patients, either pre-treated with a constant dose of < or = 500 µg fluticasone (or equivalent) per day only, or pre-treated with a constant dose of < or = 250 µg fluticasone (or equivalent) per day in combination with: -- an inhaled long-acting ß-agonists (LABA) in a fixed or free combination, or -- sustained-release theophylline, or -- a leukotriene antagonist, or -- a lipoxygenase inhibitor, or -- an inhaled anticholinergic, or -- an oral ß-agonist, or -- inhaled disodium cromoglycate, or -- inhaled nedocromil during at least four weeks prior to entry in the study. |
|
E.4 | Principal exclusion criteria |
Diseases and health status: - Clinically relevant abnormal laboratory values (e.g. abnormal serum potassium and glucose levels) suggesting an unknown disease and requiring further clinical evaluation, - Concomitant severe diseases or diseases which are contraindications for the use of inhaled corticosteroids (ICS) (e.g. active and inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment), or contra-indications for the use of long-acting beta2-agonists (LABAs, e.g. di-agnosis or history of significant cardiovascular diseases, insulin-dependent diabetes mellitus, uncontrolled hypertension, hyperthyroid-ism, thyrotoxicosis, phaeochromocytoma, hypokalaemia, prolonged QTc interval (male > 430ms, female > 450ms) or tachyarrhythmia, - Suffering from chronic obstructive pulmonary disease (COPD) (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function (e.g. infection of lower airways within 4 weeks prior to entry into the study), - Current smoking or cessation of smoking within the last 6 months, - Previous smoking with a smoking history > or = 10 cigarette pack-years, - More than one in-patient hospitalization or emergency care visit due to asthma exacerbations in the past year before B0
Medications: - Use of injectable glucocorticosteroids or oral systemic glucocorticos-teroids within 2 months prior to entry into the study, or more than 3 courses during the last 6 months,· - Use of other drugs not allowed and washout times of prohibited drugs cannot be adhered to, - Known or suspected hypersensitivity to ICS, salmeterol, formoterol, lactose monohydrate or to other excipients of the DPI, - Known or suspected hypersensitivity to salbutamol or to excipients of the MDI, - Beginning of immunotherapy within the study period, - Pre-treatment with variable doses of ICS, either alone or in combina-tion with a non-steroidal controller, during the last 4 weeks prior to en-try into baseline period
Common criteria: - Pregnancy or intention to become pregnant during the course of the study, breast feeding, or 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 employees at the investigational site, - 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). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary variable:· - FEV1 (last value compared to T0).
Co-Primary variable: - Proportion of days on which a patient perceived asthma control (based on asthma symptom-free and rescue medication-free days).
Secondary variables: - Morning and evening PEF from electronic diary (last week and weekly comparisons to W0), - FEV1 (T6 and T3 compared to T0), - FVC (last value, T6 and T3 compared to T0), - FEF25-75% (last value, T6 and T3 compared to T0) - Asthma symptom score (24 h, daytime as well as nighttime score) (last week and weekly comparisons to W0), - Use of rescue medication (last week and weekly comparisons to W0), - Proportion of days without nocturnal awakenings, - Proportion of days without use of rescue medication, - Proportion of days without asthma symptoms, - Onset of action as assessed by morning and evening PEF, asthma symptoms and use of rescue medication, - Time to the first asthma exacerbation, - Proportion of patients with an asthma exacerbation.
Safety variables: - Physical examination, - Vital signs (ECG, BP, HR), - 24 h urine cortisol levels, - AEs, - Laboratory examinations, - Number of patients with oral candidiasis confirmed by culture. - Number and diameter assessment of skin bruises |
|
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 | No |
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
| |
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 | 5 |
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 | 5 |