Study title:
Comparison of nebulized beclomethasone dipropionate and nebulized budesonide in asthma of infants and young children. Multicentre, randomized, controlled, open-label study versus reference product in 2 parallel groups over 14 weeks including a 2-week run-in , in severe or persistent asthma in infants and young children of the equivalent safety and efficacy of the addition, to the usual maintenance treatment, of 800 µg of nebulized beclomethasone dipropionate or 750 µg of nebulized Pulmicort® twice a day.
Type of medicine: Medicines containing chemical active substances
|
Therapeutic area: Respiratory Tract Diseases [C08]
|
Brands: please see report |
MAH holders: please see report |
Assessment: |
Active substance: BECLAMETHASONE |
ATC code: |
Document link:
|
Document date:
|
Study number: P/14.04/CT/02/97 |
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
|
Y
|