Study of Safety of Foradil in Patients With Persistent Asthma

Status Completed

Clinical Trial Summary

The purpose of this study is 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 is the same as those taking inhaled fluticasone propionate alone.

Clinical Trial Description

This is 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 is 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01845025
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 4
Start date	May 2013
Completion date	May 2016

View Details

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