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Completed

NCT Number: 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).

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

"IPSMCPP-D-R Veleva" EOOD, Burgas, Bulgaria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHF5993 200/6/12.5 μg pMDI HFA-152a

Drug

Pressurised Metered Dose Inhaler-2 inhalations twice daily

Other names: HFA-152a propellant

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

Drug

Pressurised Metered Dose Inhaler-2 inhalations twice daily

Other names: HFA-134a propellant

Primary outcomes

  1. 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)

    Time frame: Day 1

    Relative change from pre-dose in FEV1 at the 10 min post-dose timepoint

Secondary outcomes

  1. To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1)

    Time frame: Day 1, Day 7, Week 4, Week 12

    Relative change from pre-dose in FEV1 at all the post dose timepoints

  2. To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1)

    Time frame: Day 1, Day 7, Week 4, Week 12

    Absolute change from pre-dose in FEV1 at all post-dose timepoints

  3. 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)

    Time frame: 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%

  4. 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)

    Time frame: Day 1, Day 7, Week 4, Week 12

    Absolute and relative changes from baseline in pre-dose FEV1 at all clinical visits

  5. To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1)

    Time frame: Day 1, Day 7, Week 12

    Change from pre-dose in FEV1 AUC 0-2h

  6. Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period

    Time frame: 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

  7. Percentage of days without intake of rescue medication.

    Time frame: 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

  8. Change in the average daily use of rescue medication.

    Time frame: 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)

  9. Change on the average daily asthma symptoms.

    Time frame: 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.

  10. Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score.

    Time frame: 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).

Other outcomes

  1. To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of Adverse Events (AEs) / Adverse Drug Reactions (ADRs).

    Time frame: Through study completion, an average of 1 year

    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)

  2. To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of number of Adverse Events (AEs) of particular interest.

    Time frame: Through study completion, an average of 1 year

    Number of AEs for each of the following event: cough, dysphonia, paradoxical bronchospasm, hypersensitivity reactions, severe asthma Exacerbations

  3. To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of incident rate of Adverse Events (AEs) of particular interest.

    Time frame: Through study completion, an average of 1 year

    Incident rate for each of the following AE of particular interest: cough, dysphonia, paradoxical bronchospasm, hypersensitivity reactions, severe asthma Exacerbations.

  4. To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of rate ration of Adverse Events (AEs) of particular interest.

    Time frame: Through study completion, an average of 1 year

    Rate ratio between treatments for each of the following AE of particular interest: cough, dysphonia, paradoxical bronchospasm, hypersensitivity reactions, severe asthma Exacerbations.

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study 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.

Acronym: TRECOS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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