At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating CHF 5993 200/6/12.5 µg, CHF 1535 200/6 µg, and 1 other intervention for Asthma. Completed, enrolled 1,437 participants across 244 sites in 17 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Treatment A: CHF 5993 200/6/12.5 µg: 2 inhalations bid Total daily dose: 800/24/50 µg BDP/FF/GB
Treatment B: CHF 1535 200/6 µg: 2 inhalations bid Total daily dose: 800/24 µg BDP/FF
Treatment C (open-label arm): CHF 1535 200/6 µg: 2 inhalations bid \+ Tiotropium Respimat 2.5 µg: 2 inhalations od Total daily dose: 800/24 µg BDP/FF + 5 µg Tio