Moderate to severe asthma bronciale in pediatric MedDRA version: 7.0 Level: LLT Classification code 10003555
Conditions
Interventions
Trade Name: Fomeda® Easyhaler® 12 micrograms/dose inhalation powder
Product Name: Formoterol Easyhaler®
Pharmaceutical Form:
INN or Proposed INN: Formoterol fumarate dihydrate
Concentration unit: µg
Sponsors
HEXAL AG (Project Management on behalf of the Sponsor: HEXAL Pharmaforschung GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: The efficacy of Formoterol Easyhaler® 12 µg Formoterol / dose will be under investigation.;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. | — |
Countries
Lithuania
Outcome results
None listed