NCT02676089

TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)

A 52 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 3-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 200/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 200/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) ALONE OR ON TOP OF OPEN-LABEL TIOTROPIUM 2.5 µg RESPIMAT® IN PATIENTS WITH ASTHMA UNCONTROLLED ON HIGH DOSES OF INHALED CORTICOSTEROIDS IN COMBINATION WITH LONG-ACTING ß2-AGONISTS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,433 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the superiority of CHF 5993 200/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) versus CHF 1535 200/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate) and to compare the effect of CHF 5993 200/6/12.5 µg pMDI vs CHF 5993 200/6/12.5 µg plus open-label Tiotropium 2.5µg, in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	CHF 5993 200/6/12.5 µg
DRUG	CHF 1535 200/6 µg
DRUG	CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg

Timeline

• Start date: 2016-04-06
• Primary completion: 2018-05-28
• Completion: 2018-05-28
• First posted: 2016-02-08
• Last updated: 2021-04-08

Locations

244 sites across 17 countries: Argentina, Belarus, Bulgaria, Czechia, Germany, Hungary, Italy, Lithuania, Poland, Portugal, Romania, Russia, Slovakia, Spain, Turkey (Türkiye), Ukraine, United Kingdom