E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe asthma bronciale in pediatric |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003555 |
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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 objective of this study is to evaluate the longterm safety of Formoterol Easyhaler® 12 µg Formoterol / dose in pediatric patients with moderate to severe persistent asthma in whom a treatment with corticosteroids is not sufficient. |
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E.2.2 | Secondary objectives of the trial |
The efficacy of Formoterol Easyhaler® 12 µg Formoterol / dose will be under investigation. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Written informed consent signed by both parents, if possible, or legal guardian and by the patient, if applicable, for study participation, prior to protocol specific procedures 2. Participation in study 2003-51-DPI-2 until regular study termination at visit 6. 3. Randomization to Formoterol Easyhaler® in period 2 of study 2003-51-DPI-2
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E.4 | Principal exclusion criteria |
1. Significant medical condition or laboratory profile that came up during the study 2003-51-DPI-2 and that might compromise the patient’s safety, compliance, or interfere with the evaluation or preclude completion, such as, but not exclusively, the following: 2. Severe renal and / or hepatic impairment as judged by the investigator 3. Severe or unstable cardiovascular diseases, e.g. coronary artery disease, myocardial infarction and decompensated congestive heart failure 4. Tachycardiac rhythm disorders; AV-block III°, idiopathic subvalvular coarctation of the aorta, hypertrophic obstructive cardiomyopathy; prolonged QT-intervall (QTc > 0.44 seconds) or any clinically relevant abnormalities in 12-lead ECG 5. Diabetes 6. Not adequately controlled hyperthyroidism 7. Occlusive vascular diseases, especially arteriosclerosis, arterial hypertension (baseline systolic blood pressure at rest above 180 mmHg and/or diastolic blood pressure above 100 mmHg on visit 6) and aneurysm 8. Pulmonary hypertension 9. Pheochromocytoma 10. Occurrence of a malignancy during the previous 6 months 11. Pregnant or nursing women 12. Women of childbearing potential, who are not using and not willing to use medically reliable methods 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 any other criteria considered sufficiently reliable by the investigator in individual cases. 13. Known hypersensitivity to any components of the preparations and / or to other ß2-agonists 14. Investigator’s suspicion of alcohol or drug abuse 15. Lack of sufficient co-operation / compliance 16. Psychosocial problems 17. Previous or simultaneous participation in this study or any other clinical study, except study 2003-51-DPI-2, within 8 weeks preceding visit 6.
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E.5 End points |
E.5.1 | Primary end point(s) |
As this is a safety longterm study, the rate of adverse events considering the patient´s compliance (if applicable) is the primary criterion. |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
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 | 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 | 8 |
E.8.9.1 | In the Member State concerned days | |