Study title: Randomized, Double-Blind, Parallel Comparison of Atrovent Nasal Spary 0.03% (42 μg/nostril) Versus Placebo Administered Twice a Day in Pediatric Patients with Allergic or Nonallergic Perennial Rhinitis with an Optional 6- Month Treatment Comparison of Atrovent Nasal Spray 0.03% (42 μg/nostril) Versus Beconase AQ (84 μg/nostril)
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: IPRATROPIUM | |||||
ATC code: | |||||
Document link: Ipratropium bromide_U96-3125_synopsis.pdf | |||||
Document date: 2011-09-22 | |||||
Study number: U96-3125 | |||||
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 | - |