NCT06264674

Comparison Between CHF5993 pMDI 200/6/12.5 µg HFA-152a VS CHF5993 pMDI 200/6/12.5 µg HFA-134a in Subjects With Asthma (TRECOS).

A 12-week Double-blind, Multicentre, Randomised, Active-controlled, 2-arm, Parallel-group Clinical Trial to Evaluate the Safety of CHF5993 pMDI 200/6/12.5 μg HFA-152a, Compared to CHF5993 pMDI 200/6/12.5 μg HFA-134a, in Subjects With Asthma.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 827 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The CLI-05993AB6-03 Study is an interventional study designed to investigate the safety and efficacy of a new low global warming potential propellant (HFA-152a) compared to the currently approved one (HFA-134a) in the medication (CHF5993) in patients with moderate to severe asthma

Detailed description

Outpatients attending the hospital clinics/study centers will be recruited. Moderate to severe controlled asthma adult subjects will be recruited. A total of 513 subjects will be randomised. The whole study will last approximately 16 weeks for each subject.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	CHF5993 200/6/12.5 μg pMDI HFA-152a	Pressurised Metered Dose Inhaler-2 inhalations twice daily
DRUG	Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a	Pressurised Metered Dose Inhaler-2 inhalations twice daily

Timeline

• Start date: 2023-11-27
• Primary completion: 2025-02-18
• Completion: 2025-02-24
• First posted: 2024-02-20
• Last updated: 2026-04-14

Locations

118 sites across 14 countries: Bulgaria, Czechia, Georgia, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Serbia, Slovakia, Spain, United Kingdom