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FORTE: Foster vs Seretide Step-down in Asthma

NCT00497237Phase 3

Key facts

Status: Completed
Start: Apr 2007
Primary completion: Mar 2010
Countries: 3
Sponsor: Chiesi Farmaceutici S.p.A.
Modality: Orthosteric Ligands

Drugs: beclometasone dipropionate + formoterol
Conditions: asthma

Overview

Phase 3, randomised, open-label trial of beclometasone dipropionate + formoterol in asthma (2 arms), sponsored by Chiesi Farmaceutici S.p.A. Primary endpoint: Morning pre-dose Peak Expiratory Flow. Started Apr 2007; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Foster
Beclomethasone 400 mcg + Formoterol 24 mcg daily
Seretide
Fluticasone 500 mcg + Salmeterol 100 mcg daily

Who it enrols

Adults with moderate persistent asthma controlled on high-dose fluticasone/salmeterol for at least 4 weeks, with FEV1 >= 80% predicted.

Endpoints

Primary

Morning pre-dose Peak Expiratory Flowmean of last 2 weeks of treatment

Secondary

Symptom scores and symptom free daysevery 2 weeks
Morning and evening pre-dose PEF and FEV1mean each 2-week period
Pulmonary function tests measured at clinicsat each clinic visit
Change of FEV1 from pre-dose to post-doseend of treatment visit
Number, frequency and severity of exacerbationswhole study period
Adverse events and adverse drug reactionsat each visit
Use of relief salbutamoldaily
Proportion of patients with controlled asthmaweekly

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