Study title: A comparison of the effectiveness of treatment with Symbicort® Turbuhaler® (budesonide/formoterol; 160/4.5 µg) Single Inhaler Therapy and Seretide™ Diskus™ (salmeterol/fluticasone; 50/100, 50/250 or 50/500 µg) plus Ventoline™ (salbutamol) as needed in steroid-treated adult and adolescent asthmatic subjects. A randomised, open, parallel-group, phase IIIB, multicentre, 12-month study.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Respiratory Tract Diseases [C08] | |||||
Brands: | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: BUDESONIDE AND FORMOTEROL | |||||
ATC code: | |||||
Document link: SD-039-0735 CSR Synopsis.pdf | |||||
Document date: 2011-09-15 | |||||
Study number: SD-039-0735 | |||||
EudraCT number: | |||||
Scope of study: Clinical | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
- | - | - | - | Y |