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 | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003555 |
E.1.2 | Term | Asthma bronchial |
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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 ciclesonide (CIC; 40 µg, 80 µg and 160 µg ex mouthpiece) vs. placebo, both administered either with or without a spacer once daily (OD) in the evening (PM), in children with persistent asthma. |
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E.2.2 | Secondary objectives of the trial |
- To further study the dose response of CIC 40 µg, 80 µg and 160 µg ex mouthpiece, administered either with or without a spacer in children. - To investigate the safety and tolerability of CIC 40 µg, 80 µg and 160 µg ex mouth-piece, administered either with or without a spacer in children. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female outpatients aged 6 to 11 years, - History of persistent bronchial asthma (as defined by GINA 2004 criteria) for at least 6 months, - Ability to perform reproducible pulmonary function tests, - Ability to show optimal use of MDI, including inhalation technique, - Either treatment with rescue medication prn only or treatment with ICS (not exceeding 200 µg/d fluticasone propionate [FP] or equivalent), or treatment with a non-ICS controller drug (e.g., cromones, xanthines, leukotriene antagonists, lipoxygenase inhibitors. or inhaled long-acting ß2-agonists [LABA]), respectively, at a constant dose over the last 30 days directly prior to B0, - PEF (% of predicted value) measured by spirometry at least 4 hours after inhalation of rescue medication (e.g. a short-acting ß2-agonist [SABA]), and at least 24 hours after the use of LABA, xanthines, or oral bronchodilators: - 40% - 90% for patients using rescue medication only, - 50% - 100% for patients using ICS, - 50% - 100% for patients using non-ICS controller drugs. |
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E.4 | Principal exclusion criteria |
The presence of any one of the following will cause exclusion of the patient:
a) Diseases and health status:
- Concomitant severe diseases, - Diseases which are contraindications for the use of ICS (e. g. active or inactive pulmonary tuberculosis, or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment), - Chronic obstructive pulmonary disease (COPD; i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function, - Respiratory tract infection or asthma exacerbation within the last 30 days prior to B0 as well as during baseline, - Two or more inpatient hospitalizations for asthma within the last year (with the exception of hospitalizations for diagnostic reasons), - Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation, - History of life-threatening asthma (i.e. prior intubation for asthma and/or respiratory arrest, anoxic seizures, significant hypercarbia in the setting of an asthma exacerbation), - Premature birth (i.e. < 36 weeks gestation), - Current smoking, - Smoking history with either equal or more than 10 pack-years (equal or more than 2 pipe pack-years).
b) Medications:
- Use of systemic steroids within the last 30 days (injectable depot steroids 6 weeks) prior to B0 or for more than 60 days within the last 2 years, - Use of ICS within the last 30 days prior to B0 at doses higher than 200 µg/d FP or equivalent, - Use of a fixed or free combination of ICS and a non-ICS controller drug within the last 30 days prior to B0, - Use of other drugs not allowed during the study or non-adherence to the given withhold times prior to B0, - Regular use of rescue medication for prophylactic reasons, - Known or suspected hypersensitivity to ICS and/or to excipients of the CIC MDI, - Known or suspected hypersensitivity to salbutamol and/or to excipients of the MDI, - Beginning of or change in immunotherapy within the last 6 months prior to B0 and during the study period, - Use of concomitant medication, which is contraindicated for patients with bronchial asthma.
c) Other criteria: - Pregnancy, - Intention to become pregnant during the course of the study, - Breast feeding, - Lack of safe contraception (in all females > or = 10 years of age or post-menarchal):
Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. - 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, due to e.g. language problems, psychological disorders, - Patient’s parent(s)/legal guardian(s) is(are), in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, - Patient or parent(s)/legal guardian(s) intend(s) 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) |
Morning peak expiratory flow from diary (last week compared to week 0 [W0]) |
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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 | Yes |
E.6.10 | Pharmacogenetic | No |
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 | 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) | 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 | 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) | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
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 | No |
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 |