CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,155 enrolled / 1,155 target
Drug / intervention
CHF 5993 100/6/12.5 +1 moredrug
Likely dose
CHF 1535 100/6 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02676076
NCT02676076Phase 3CompletedHigh Momentum (9.3/mo)Completion was 97mo ago
CompareCT.gov

A 52 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 2-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 100/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 100/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) IN PATIENTS WITH ASTHMA UNCONTROLLED ON MEDIUM DOSES OF INHALED CORTICOSTEROIDS IN COMBINATION WITH LONG ACTING ß2 AGONISTS

Chiesi Farmaceutici S.p.A.·interventional·Posted Feb 8, 2016·Updated Jun 26, 2026

In Brief

A Phase 3 clinical trial evaluating CHF 5993 100/6/12.5 and CHF 1535 100/6 µg for Asthma. Completed, enrolled 1,155 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed Summary

Evaluate the superiority of CHF 5993 100/6/12.5 µg Pressurised Metered Dose Inhaler (pMDI) (fixed combination of extrafine beclometasone dipropionate (BDP) plus formoterol fumarate (FF) plus glycopyrronium bromide \[GB\]) versus CHF 1535 100/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate (BDP) plus formoterol fumarate \[FF\]), with regard to lung functions parameters and rate of exacerbations as well as safety and health economics outcomes, in adult patients with uncontrolled asthma on medium doses of inhaled corticosteroids in combination with long acting ß2 agonists (LABA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 8, 2016
Enrollment StartFeb 17, 2016
Primary CompletionMay 17, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.4 years ago

Arms & Interventions

CHF 5993 100/6/12.5 µgexperimental

CHF 5993 100/6/12.5 CHF 5993 100/6/12.5 µg: 2 inhalations bid Total daily dose: 400/24/50 µg BDP/FF/GB BDP=Beclometasone Dipropionate bid=Twice daily FF=Formoterol Fumarate GB=Glycopyrronium Bromide

Drug: CHF 5993 100/6/12.5
CHF 1535 100/6 µgactive_comparator

CHF 1535 100/6 µg CHF 1535 100/6 µg: 2 inhalations bid Total daily dose: 400/24 µg BDP/FF BDP=Beclometasone Dipropionate bid=Twice daily FF=Formoterol Fumarate

Drug: CHF 1535 100/6 µg

Interventions

CHF 5993 100/6/12.5drug

BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg; GB=Glycopyrronium Bromide 12.5µg.

CHF 1535 100/6 µgdrug

BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg.