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

Phase 3 Completed NCT02676089

Condition	Asthma
Phase	Phase 3
Sponsor	Chiesi Farmaceutici S.p.A.
Status	Completed
Enrollment	1,437 participants
Interventions	CHF 5993 200/6/12.5 µg, CHF 1535 200/6 µg, CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg
Start date	Apr 6, 2016
Completion date	May 28, 2018
Results posted	May 29, 2026

Summary

Evaluate the superiority of CHF 5993 200/6/12.5 µg pressurised metered dose inhaler (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) in patients with uncontrolled asthma under medium doses of inhaled corticosteroid/long-acting β2-adrenergic receptor agonists (ICS/LABA), in patients with uncontrolled asthma who received medium doses of ICS/LABA. The treatments tested the improvement of the forced expiratory volume in the 1st second (FEV1) and the reduction of moderate and severe asthma exacerbations rate.

1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26

Week 0 (pre-treatment, baseline) to Week 26. · Liter

CHF 5993 200/6/12.5 µg	0.229 Liter
CHF 1535 200/6 µg	0.157 Liter
CHF 1535 200/6 µg + Tiotropium (Tio) 2.5 µg	0.274 Liter

p-value	0.003
Least square mean difference	0.073 (95% CI 0.026–0.120)

2_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period

Week 0 (pre-treatment, baseline) to Week 52. · events/year

CHF 5993 200/6/12.5 µg	1.726 events/year
CHF 1535 200/6 µg	1.963 events/year
CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg	1.613 events/year

p-value	0.110
Adjusted rate ratio	0.880 (95% CI 0.751–1.030)

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

A Study of Remote Asthma Management Using an Integrated Artificial Intelligence-assisted E — Mayo Clinic
Developing a Childhood Asthma Risk Passive Digital Marker — Indiana University
A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With C — Chiesi Farmaceutici S.p.A.
A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to — Hoffmann-La Roche
A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Cortic — Hoffmann-La Roche
Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Sev — AstraZeneca

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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