Conditions: Persistent Asthma
Keywords: Asthma formoterol fumarate Foradil inhaled corticosteroid fluticasone propionate safety
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 827
Healthy volunteers: no

Brief summary:
The purpose of this study was to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in adolescents and adults (12 years of age and older) taking inhaled formoterol fumarate/fluticasone propionate combination was the same as those taking inhaled fluticasone propionate alone.

Detailed description:
This was a 26 week, double blind, randomized, active-controlled safety study of Foradil in free combination with inhaled corticosteroid versus an inhaled corticosteroid alone in adults and adolescent patients with persistent asthma. The primary objective of the study was to demonstrate that the addition of formoterol fumarate to fluticasone propionate is non-inferior to fluticasone propionate alone in terms of the risk of composite serious asthma related events (asthma-related hospitalization, asthma-related intubation, and asthma-related death). The individual components of the composite primary endpoint (i.e., asthma-related hospitalization, asthma-related intubation and asthma-related death) will be assessed as a secondary safety endpoints.

The efficacy assessment is the secondary objective.

Arms:
arm 1: Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation arm 2: fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation

Interventions: intervention 1: Formoterol 12 mcg intervention 2: Fluticasone propionate 100 mcg intervention 3: Fluticasone propionate 250 mcg intervention 4: Fluticasone propionate 500 mcg intervention 5: Placebo
Intervention descriptions: intervention 1: Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler intervention 2: Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler intervention 3: Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler intervention 4: Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler intervention 5: Placebo to match formoterol one inhalation twice daily via dry powder inhaler

Protocol document: