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A Phase III, 52-week, Multinational, Multicenter, Randomized, Double-blind, 2-arm Parallel Group Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide (CHF 5993) With the Fixed Dose Dual Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate (CHF 1535), Both Administered Via pMDI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510172-31-00
Acronym
CLI-05993AA3-06
Enrollment
1149
Registered
2024-06-06
Start date
2022-04-22
Completion date
2025-12-29
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD)

Brief summary

Change from baseline in pre-dose morning FEV1 at week 28 (V7)

Detailed description

Change from baseline in 2-hour post-dose morning FEV1 at week 28 (V7), Rate of moderate and severe COPD exacerbations over 52 weeks of treatment, SGRQ response (Decrease from baseline in total score ≥4) at Week 28, Incidence of treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), serious ADRs, serious AEs (SAEs), severe AEs, TEAEs leading to discontinuation from study drug, and TEAEs leading to death, Incidence of treatment-emergent pneumonia, Incidence of treatment-emergent major adverse cardiovascular events (MACE).

Interventions

DRUGtraining kit
DRUGCHF1535 pMDI 100/6
DRUGCHF5993 pMDI-US

Sponsors

Chiesi Farmaceutici S.p.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in pre-dose morning FEV1 at week 28 (V7)

Secondary

MeasureTime frame
Change from baseline in 2-hour post-dose morning FEV1 at week 28 (V7), Rate of moderate and severe COPD exacerbations over 52 weeks of treatment, SGRQ response (Decrease from baseline in total score ≥4) at Week 28, Incidence of treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), serious ADRs, serious AEs (SAEs), severe AEs, TEAEs leading to discontinuation from study drug, and TEAEs leading to death, Incidence of treatment-emergent pneumonia, Incidence of treatment-emergent major adverse cardiovascular events (MACE).

Countries

Bulgaria, Czechia, Hungary, Poland, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026