Conditions: Asthma
Keywords: asthmatic children Symbicort Foradil
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 54
Healthy volunteers: no

Brief summary:
This purpose of the study is to investigate the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as Symbicort pMDI.

Detailed description:
A Phase 2, randomized, blinded, 5-period cross-over, placebo and active controlled, multicenter, dose-finding study comparing single doses of formoterol 2.25 µg, 4.5 µg, and 9 µg delivered via Symbicort pMDI and Foradil® 12 µg evaluating the relative bronchodilating effects and safety in children.

Arms:
arm 1: 2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI × 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations arm 2: placebo HFA pMDI × 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI × 2 inhalations) arm 3: placebo HFA pMDI × 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI × 2 inhalations) arm 4: placebo HFA pMDI × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations arm 5: Foradil Aerolizer 12 μg × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations

Interventions: intervention 1: 80/2.25 μg Symbicort pMDI intervention 2: 80/4.5 μg Symbicort pMDI intervention 3: Foradil Aerolizer 12 μg intervention 4: 40 μg budesonide HFA pMDI intervention 5: placebo HFA pMDI
Intervention descriptions: intervention 1: inhalation intervention 2: inhalation intervention 3: inhalation intervention 4: inhalation intervention 5: inhalation

Protocol document: