NCT01845025

Study of Safety of Foradil in Patients With Persistent Asthma

A 26 Week, Randomized, Active-controlled Safety Study of Double-blind Formoterol Fumarate in Free Combination With an Inhaled Corticosteroid Versus an Inhaled Corticosteroid in Adolescent and Adult Patients With Persistent Asthma.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 827 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Asthma

Interventions

Type	Name	Description
DRUG	Formoterol 12 mcg	Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler
DRUG	Fluticasone propionate 100 mcg	Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler
DRUG	Fluticasone propionate 250 mcg	Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler
DRUG	Fluticasone propionate 500 mcg	Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler
DRUG	Placebo	Placebo to match formoterol one inhalation twice daily via dry powder inhaler

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2013-05-03
• Last updated: 2017-03-21
• Results posted: 2017-03-21

Locations

27 sites across 1 country: United States