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 assess the efficacy of ciclesonide (CIC) 40 µg, 80 mg, and 160 mg (ex mouthpiece) in asthmatic children 2 to 6 y old. |
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E.2.2 | Secondary objectives of the trial |
To study the safety and tolerability of ciclesonide. |
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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 by the patient’s parents or legal guardians, · Male or female outpatients, · Age 2 to 6 y, · Good health with the exception of asthma, · Documented diagnosis of asthma for > or = 6 months with persistent or repeated wheezing, and one or more major risk factors, e.g.: - history of allergies, - history of eczema, - family history of asthma, and/or two or more minor risk factors, e.g.: - eosinophilia, - dyspnoea without having a cold, - allergic rhinitis.
Only in case risk factors cannot be determined, a positive Phadiatop result (determined at B0) will be accepted. · Stable clinical state (e.g. no asthma exacerbation or respiratory tract infection within the last 30 d prior to B0), · Either, - use of rescue medication (prn) only, or - pre-treatment with < or = 250 µg fluticasone propionate/d (or equivalent), or - pre-treatment with < or = 125 µg fluticasone propionate/d (or equivalent) in combination with a LABA and/or with another non-steroidal controller medication, or - pre-treatment with other non-steroidal controller medication, at a constant dosage for at least 30 d prior to B0 |
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E.4 | Principal exclusion criteria |
Diseases and health status: · Concomitant severe diseases, · Diseases contraindicated 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, nematode infestation), · Other relevant lung diseases causing impairment in pulmonary function, · Hospitalization due to respiratory syncytial virus (RSV) bronchiolitis within the last 12 months prior to B0, · Three or more hospitalizations for wheezing, coughing, or shortness of breath within the last 12 months prior to B0, · Recurrent, episodic wheezing only, · History of life-threatening asthma (i.e. intubation for asthma and/or respiratory arrest, anoxic seizures, significant hypercapnia in the setting of an asthma exacerbation), · History of any mechanical ventilation, · Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation,· Premature birth (i.e. <32 weeks gestation),· Height outside normal height percentile (= 5-95%)
Medication: · Known or suspected hypersensitivity to inhaled steroids or to other excipients of the MDI, · Known or suspected hypersensitivity to salbutamol or montelukast, · Regular use of rescue medication for prophylactic reasons, · Use of systemic steroids within the last 30 d (injectable depot steroids: 6 weeks) prior to B0, or on more than 60 d within the last 2 y, · Use of prohibited medication or washout times of prohibited medication cannot be adhered to, · Beginning or change of immunotherapy within the study period · Systemic treatment for non-respiratory chronic or recurrent diseases,
Other criteria: · Participation in another study within the last 30 d (for Brazil only: 1 y) prior to B0, · Previous enrollment into the current study, · Known or suspected non-compliance of parents/legal guardians and/or patients (e.g. inability to follow study procedures, language problems),Intention of the parents/legal guardians and patients to relocate during the study, preventing adherence to the visit schedule |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy variable of primary interest: · Time to first lack of improvement or severe asthma exacerbation
Efficacy variable of secondary interest: · Rate of patients with lack of improvement or severe asthma exacerbation · Rate of patients with lack of improvement · Rate of patients with severe asthma exacerbation · Time to first lack of improvement · Time to first severe asthma exacerbation · Asthma symptom score from diary (total, daytime, and nighttime) · Use of rescue medication · Patient perceived asthma control · Quality of life data (PACQLQ) · Morning and evening PEF from diary* · PEF fluctuation*· · Pulmonary function variables (FEV1, PEF, FEF25-75%) measured at the investigational sites*
*(in 4 to 6 y old patients, able to perform reliable pulmonary function measurements)
Safety variables of interest: · Adverse events · Physical examination · Vital signs · Laboratory work-up · Serum cortisol · Urine cortisol variables (first morning urine) · Body growth determined by stadiometry (selected sites) |
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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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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
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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 | 13 |
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 | 13 |