Study title: TO COMPARE THE BRONCHODILATOR EFFICACY, DURATION OF EFFECT,AND SYSTEMIC TOLERABILITY OF SINGLE INHALED DOSES OF FORMOTEROL, SALBUTAMOL ANF PLACEBO IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE (ASTHMA). CLINICAL TRIAL SUMMARY AND REPORT
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Respiratory Tract Diseases | |||||
Brands: | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: FORMOTEROL | |||||
ATC code: R03AC13 | |||||
Document link: FOR258 DFORC4 Art45 listing 2011.xls | |||||
Document date: 2011-11-22 | |||||
Study number: DFORC4 | |||||
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) |
- | - | - | - | - |