Comparison Between CHF5993 pMDI 200/6/12,5mg HFA-152a VS CHF5993 pMDI 200/6/12,5mg HFA-134a in Subjects With Asthma (Trecos)

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: CHF5993 200/6/12.5 μg pMDI HFA-152a; Drug: Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a

• Registration Number: NCT06264674
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

The CLI-05993AB6-03 Study is an interventional study designed to compare potential for bronchoconstriction, safety and tolerability profile using of HFA 152a propellant versus using to HFA 134a.

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.

Study Timeline

• Study First Submitted: 2023-11-13
• Study Start: 2023-11-27
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-20
• Primary Completion: 2024-11-20
• Study Completion: 2025-02-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 836

Inclusion Criteria

• Subject's written informed consent obtained prior to any study related procedure;
• Male and female adults aged ≥ 18 and ≤ 75;
• Body mass index (BMI) within the range of 18.0 to 35.0 kg/m2 inclusive;
• Non-smokers or ex-smokers who smoked < 10 pack-years (pack-years = the number of cigarette packs per day x the number of years) and stopped smoking > 1 year (6 months for e-cigarettes) prior to screening;
• Diagnosis of asthma: physician-diagnosed asthma for at least
• 6 months and with diagnosis before the age of 50 years;
• Stable asthma therapy: a stable treatment with medium/high doses of inhaled corticosteroids (ICS) + long-acting β-agonist (LABA) + long-acting muscarinic antagonist (LAMA) (fixed or free combination) or medium/high doses of ICS+LABA (fixed or free combination) for at least 4 weeks before screening (medium and high-dose ICS defined as BDP non-extrafine > 500-1000 μg and > 1000 μg respectively, or estimated clinical comparable dose).
• Subjects must have a cooperative attitude and the ability to be trained to use correctly the pMDI inhalers and e-Diary, to be able to read/write, to be able to perform the required outcomes measurements (e.g., technically acceptable spirometry, e-Diary completion) and the ability to understand the risks involved.

Exclusion Criteria

• History of near fatal asthma, hospitalisation for asthma in intensive care unit which in the judgement of the Investigator may place the subject at undue risk, emergency room access for asthma in the previous 6 months before enrolment;
• Asthma exacerbation requiring systemic corticosteroids (SCS) or emergency room admission or hospitalisation within 4 weeks prior to study entry and/or during the run-in period (to be checked again prior to randomisation);
• Non-permanent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medecine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaler CHF5993 200/6/12.5 μg pMDI HFA-152a	CHF5993 200/6/12.5 μg pMDI HFA-152a	Active ingredients: BDP/FF/GB 200/6/12.5 μg per actuation; Excipients: HFA-152a propellant.
Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a	Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a	Active ingredients: BDP/FF/GB 200/6/12.5 μg per actuation; Excipients: HFA-134a propellant.

Primary Outcome Measures

Name	Time	Method
Relative change from pre-dose Forced Expiratory Volume in one second with (FEV1) (Safety Assessment to evaluate of the potential bronchoconstriction of the study treatment)	Day 1	Relative change from pre-dose in FEV1 at the 10 min post-dose timepoint

Secondary Outcome Measures

Name	Time	Method
Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period	Inter-visit, over the entire 12 weeks treatment period	Change from baseline at each inter-visit period and over the entire treatment period in morning and evening PEF
To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1)	Day 1, Day 7, Week 4, Week 12	Relative change from pre-dose in FEV1 at all the post dose timepoints
Percentage of days without intake of rescue medication.	Inter-visit, over the entire 12 weeks treatment period	Change from baseline at each inter-visit period and over the entire treatment period in the percentage of days without intake of rescue medications
Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score.	At each planned on site study visit, during the entire 12 weeks treatment period.	ACQ 7 is a one week recall questionnaire including 6 questions to be completed by patients on a 7-points scale (0=no impairment, 6= maximum impairment) and 7th point capturing the FEV1 % predicted value (also scoring on a 7-point scale). Questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1)	Day 1, Day 7, Week 4, Week 12	Absolute change from pre-dose in FEV1 at all post-dose timepoints
To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (number and percentage of subjects with a relative decrease from pre-dose in FEV1)	Day 1, Day 7, Week 4, Week 12	Calculation of number and percentage of subjects with a relative decrease from pre-dose in FEV1 at each post-dose timpoint and at any post -dose timepoint \> 15%
Change in the average daily use of rescue medication.	Inter-visit, over the entire 12 weeks treatment period	Change from baseline at each inter-visit period and over the entire treatment period in the average daily use of rescue medication (number of inhalations/day)
To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Absolute and relative changes from baseline in pre-dose FEV1)	Day 1, Day 7, Week 4, Week 12	Absolute and relative changes from baseline in pre-dose FEV1 at all clinical visits
To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1)	Day 1, Day 7, Week 12	Change from pre-dose in FEV1 AUC 0-2h
Change on the average daily asthma symptoms.	Inter-visit, over the entire 12 weeks treatment period	Change from baseline at each inter-visit period and over the entire treatment period in the average daily symptoms. Patients are asked to complete daily a questionnaire to collect this information and allow their asthma symptoms to be monitored.

Trial Locations

Locations (142)

Yerevan State Medical University, Heratsi N 1 University Hospital Complex; 🇦🇲 Yerevan, Armenia

CITO Medical Center; 🇦🇲 Yerevan, Armenia

Armenia Republican Medical Center; 🇦🇲 Yerevan, Armenia

Erebuni Medical Center; 🇦🇲 Yerevan, Armenia

Nairi Medical Center; 🇦🇲 Yerevan, Armenia

"IPSMCPP-D-R Veleva" EOOD; 🇧🇬 Burgas, Bulgaria

Medical Center "Zdrave -1"; 🇧🇬 Kozloduy, Bulgaria

"AIPSMP Yuskyan Aliosman" Ltd; 🇧🇬 Momchilgrad, Bulgaria

Ambulatory for Specialized Outpatient Medical Care - Individual Practice; 🇧🇬 Ruse, Bulgaria

Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov - Ruse Ltd.; 🇧🇬 Ruse, Bulgaria

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