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).
NCT06264674 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 827
Last updated 2026-04-14
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
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Chiesi Farmaceutici S.p.A.
lead INDUSTRY
Principal Investigators
-
Dave Singh, MD · Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-27
- Primary Completion
- 2025-02-18
- Completion
- 2025-02-24
Countries
- Bulgaria
- Czechia
- Georgia
- Germany
- Greece
- Hungary
- Italy
- Netherlands
- Poland
- Romania
- Serbia
- Slovakia
- Spain
- United Kingdom
Study Locations
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