NCT05018598

Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABA

A 26 Week, Randomized, Double Blind, Multinational, Multicenter, Active Controlled, 2-arm Parallel Group Trial Comparing CHF 5993 100/6/12.5 μg pMDI (Fixed Combination of Extrafine Formulation of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to CHF 1535 200/6 μg pMDI (Fixed Combination of Extrafine Formulation of Beclometasone Dipropionate Plus Formoterol Fumarate) in Subjects With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-Acting β2-Agonists.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase IV Study is to compare the efficacy of CHF5993 (BDP/FF/GB 100/6/12.5 pMDI) on uncontrolled asthma subjects, versus CHF1535 (BDP/FF 200/6 pMDI). The open label extension part aims to assess the proportion of subjects whose asthma remains or becomes adequately controlled..

Detailed description

The study consists in two phases: The study population includes 1400 subjects that are randomly assigned to two treatment arms. Each participant will be followed for 26 weeks to assess the efficacy of CHF5993 (BDP/FF/GB 100/6/12.5 pMDI). The study population of the extension part includes 800 subjects who opt to enroll into this extension and receive either CHF5993 (BDP/FF/GB 100/6/12.5 pMDI) or CHF5993 (BDP/FF/GB 200/6/12.5 pMDI) depending on their asthma control status at the end of the main phase.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Administration via pressurized metered dose inhaler (pMDI)	CHF5993 pMDI
DRUG	Administration via pressurized metered dose inhaler (pMDI)	CHF1535 pMDI or CHF5993 pMDI

Timeline

• Start date: 2022-02-25
• Primary completion: 2024-04-16
• Completion: 2024-04-16
• First posted: 2021-08-24
• Last updated: 2024-11-15

Locations

1 site across 1 country: Hungary