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

Asthma Clinical Trial

— TRECOS  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06264674
• Other study ID #: CLI-05993AB6-03
• Secondary ID: 2023-503333-22-0
• Status: Recruiting
• Phase: Phase 3
• Start date: November 27, 2023
• Est. completion date: September 18, 2025

Study information

• Verified date: February 2024
• Source: Chiesi Farmaceutici S.p.A.
• Contact: Chiesi Farmaceutici S.p.A. Chiesi Clinical Trial Info
• Phone: + 39 0521 2791
• Email: clinicaltrials_info[@]chiesi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 790
• Est. completion date: September 18, 2025
• Est. primary completion date: August 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CHF5993 200/6/12.5 µg pMDI HFA-152a
Pressurised Metered Dose Inhaler-2 inhalations twice daily
• Inhaler CHF5993 200/6/12.5 µg pMDI HFA-134a
Pressurised Metered Dose Inhaler-2 inhalations twice daily

Locations

Country	Name	City	State
United Kingdom	Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of Adverse Events (AEs) / Adverse Drug Reactions (ADRs).	Number and percentage of subjects experiencing AEs, number and percentage of subjects experiencing at least one ADR and number and percentage of subjects experiencing at least one Treatment Emergent Adverse Events (TEAEs)	Through study completion, an average of 1 year
Other	To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of number of Adverse Events (AEs) of particular interest.	Number of AEs for each of the following event: cough, dysphonia, paradoxical bronchospasm, hypersensitivity reactions, severe asthma Exacerbations	Through study completion, an average of 1 year
Other	To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of incident rate of Adverse Events (AEs) of particular interest.	Incident rate for each of the following AE of particular interest: cough, dysphonia, paradoxical bronchospasm, hypersensitivity reactions, severe asthma Exacerbations.	Through study completion, an average of 1 year
Other	To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of rate ration of Adverse Events (AEs) of particular interest.	Rate ratio between treatments for each of the following AE of particular interest: cough, dysphonia, paradoxical bronchospasm, hypersensitivity reactions, severe asthma Exacerbations.	Through study completion, an average of 1 year
Primary	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)	Relative change from pre-dose in FEV1 at the 10 min post-dose timepoint	Day 1
Secondary	To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1)	Relative change from pre-dose in FEV1 at all the post dose timepoints	Day 1, Day 7, Week 4, Week 12
Secondary	To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1)	Absolute change from pre-dose in FEV1 at all post-dose timepoints	Day 1, Day 7, Week 4, Week 12
Secondary	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)	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%	Day 1, Day 7, Week 4, Week 12
Secondary	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)	Absolute and relative changes from baseline in pre-dose FEV1 at all clinical visits	Day 1, Day 7, Week 4, Week 12
Secondary	To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1)	Change from pre-dose in FEV1 AUC 0-2h	Day 1, Day 7, Week 12
Secondary	Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period	Change from baseline at each inter-visit period and over the entire treatment period in morning and evening PEF	Inter-visit, over the entire 12 weeks treatment period
Secondary	Percentage of days without intake of rescue medication.	Change from baseline at each inter-visit period and over the entire treatment period in the percentage of days without intake of rescue medications	Inter-visit, over the entire 12 weeks treatment period
Secondary	Change in the average daily use of rescue medication.	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)	Inter-visit, over the entire 12 weeks treatment period
Secondary	Change on the average daily asthma symptoms.	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.	Inter-visit, over the entire 12 weeks treatment period
Secondary	Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score.	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).	At each planned on site study visit, during the entire 12 weeks treatment period.