FACTO Study (Foster® As Complete Treatment Option) — FACTO

Asthmatic Patients Clinical Trial

Official title:
A PHASE 4, MULTINATIONAL, MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, PARALLEL GROUP, CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg pMDI WITH HFA-134A PROPELLANT (CHF1535, FOSTER®) VERSUS FLUTICASONE 250 µg PLUS SALMETEROL 50 µg DPI (SERETIDE® DISKUS®) AS MAINTENANCE TREATMENT IN CONTROLLED ASTHMATIC PATIENTS.

Status Completed

Clinical Trial Summary

Double blind, multinational, multicentre, randomised, 2 arm parallel group study

Clinical Trial Description

Aim of the present investigation is to demonstrate the clinical equivalence between fluticasone plus salmeterol 500/100 µg daily and an equipotent dose of CHF1535 in maintaining the same asthma control in patients adequately controlled with fluticasone plus salmeterol at the above mentioned daily dose. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00901368
Study type	Interventional
Source	Chiesi Farmaceutici S.p.A.
Contact
Status	Completed
Phase	Phase 4
Start date	May 2009
Completion date	December 2010

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See also
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