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).

Last updated: April 3, 2025
Sponsor: Chiesi Farmaceutici S.p.A.
Overall Status: Completed

Phase

3

Condition

Asthma

Treatment

Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a

CHF5993 200/6/12.5 μg pMDI HFA-152a

Clinical Study ID

NCT06264674
CLI-05993AB6-03
2023-503333-22-00
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 ofcigarette packs per day x the number of years) and stopped smoking > 1 year (6months 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 inhaledcorticosteroids (ICS) + long-acting β-agonist (LABA) + long-acting muscarinicantagonist (LAMA) (fixed or free combination) or medium/high doses of ICS+LABA (fixed or free combination) for at least 4 weeks before screening (medium andhigh-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 usecorrectly the pMDI inhalers and e-Diary, to be able to read/write, to be able toperform the required outcomes measurements (e.g., technically acceptable spirometry,e-Diary completion) and the ability to understand the risks involved.

Exclusion

Exclusion Criteria:

  • History of near fatal asthma, hospitalisation for asthma in intensive care unitwhich 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 roomadmission or hospitalisation within 4 weeks prior to study entry and/or during therun-in period (to be checked again prior to randomisation);

  • Non-permanent asthma: exercise-induced, seasonal asthma (as the only asthma-relateddiagnosis) not requiring daily asthma control medecine

Study Design

Total Participants: 836
Treatment Group(s): 2
Primary Treatment: Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a
Phase: 3
Study Start date:
November 27, 2023
Estimated Completion Date:
February 24, 2025

Study 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.

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  • Armenia Republican Medical Center

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    Yerevan, 0070
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  • Yerevan State Medical University, Heratsi N 1 University Hospital Complex

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  • "IPSMCPP-D-R Veleva" EOOD

    Burgas,
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  • Medical Center "Zdrave -1"

    Kozloduy,
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    Momchilgrad,
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  • Ambulatory for Specialized Outpatient Medical Care - Individual Practice

    Ruse, 7000
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  • Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov

    Ruse, 7002
    Bulgaria

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    Ruse, 7002
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    Shumen, 9700
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    Sliven, 8801
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    Sliven,
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  • Institut für Allergie- und Asthmaforschung

    Berlin, 12159
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  • Lungenpraxis Hohenzollerndamm

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    Bonn, 53119
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    Kamenica, 21204
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    Kragujevac,
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    Kragujevac, 34000
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    Užice, 31000
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  • F. D. Roosevelt University Hospital

    Banská Bystrica, 975 17
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    Bardejov, 085 01
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    Dunajská Streda, 929 01
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    Michalovce, 071 01
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    Spišská Nová Ves, 05201
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    Žilina, 010 01
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    Cadiz, 11008
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    Castello de la Plana, 12004
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    Girona, 17003
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    Málaga, 29010
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    Salamanca, 37007
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    Bradford, BD9 6RJ
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    London, UB9 6JH
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    London, EC1M6BQ
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    Manchester, M23 9QZ
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