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 | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003555 |
E.1.2 | Term | Asthma bronchial |
|
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 study and compare the efficacy of 2 dose levels of continuous (daily) inhalations of Ciclesonide versus placebo inhalation in addition to episodic treatment for exacerbations with regards to time to first exacerbation (episodic treatment is defined as the step-wise use of inhaled and oral corticosteroids) |
|
E.2.2 | Secondary objectives of the trial |
- To determine the effect of the different treatments on growth velocity - To study and compare the effects of the 3 different treatment arms on the rate of exacerbations over the 1 year treatment phase, on the duration of exacerbations, on pulmonary function, asthma symptoms, use of rescue medication, quality of life, and days of school / work missed - To study and compare the safety and tolerability of the three different treatment arms. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Patients giving assent and parents/guardians informed consent · Outpatients, male or female, age 4 to 11 years inclusive · Symptoms consistent with the diagnosis of asthma for at least 12 months not requiring the use of an ICS (less or equal to 250mg/day FP or equivalent) for more than 8 weeks within the last 12 months (no ICS 30 days prior to B0) · FEV1 at least 80 % of predicted, measured at least 4 hours after the inhalation of short acting b2-agonist (e.g. salbutamol), or at least 24 hours after the inhalation of a LABA (salmeterol or formoterol), anticholinergics or the oral intake of theophylline or leukotriene antagonists · Ability to perform reproducible lung function tests · With the exception of asthma, are in good health |
|
E.4 | Principal exclusion criteria |
· History of life-threatening asthma · Hospitalization for asthma within the past 3 months or > or = 2 hospitalizations within the last year. · Asthma exacerbation, or relevant RTI within the last 30 days requiring anti-asthmatic medication beyond an increase in bronchodilator dose · Initiation of immunotherapy within 6 months of B0, or planned initiation within the study period · Severe atopic dermatitis · Concomitant severe diseases or diseases which are contraindicated for the use of ICS · Relevant lung diseases causing alternating impairment in lung function · Prematurely born children (< 36 weeks of gestation) · Conditions [cardiovascular, neurological, hepatic, renal, respiratory (other than asthma or allergic rhinitis), or others] considered as clinically significant · History of cataracts and/or glaucoma · Suspected hypersensitivity to ICS or short-acting ß agonist · Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation · Use of systemic corticosteriods for > 30 days within the previous year, or within 30 days (injectable depot steriods 6 weeks) of B0 or more than 3 times during the last 6 months · Use of drugs not allowed or washout times of drugs cannot be adhered to · Need for concomitant medications that interfere with the study · Lung disease other than asthma, concomitant severe disease · Smokers · Pregnancy, intention to become pregnant during the trial or lack of safe contraception in females of child-bearing potential · Patients who are mentally incapacitated · Suspected non-compliance or inability to follow the procedures of the study · Participation in another trial within 30 days of enrolment, or previous enrolment in current study · Patient or parents relocation during the study, preventing adherence to visit schedule · Parents or legal representative are, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Time to first asthma exacerbation |
|
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 | 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 | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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 |
|
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
| |
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 | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 3 |