Comparison Between CHF5993 pMDI 200/6/12.5 µg HFA-152a VS CHF5993 pMDI 200/6/12.5 µg HFA-134a in … (NCT06264674) | Clinical Trial Compass
CompletedPhase 3
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).
Bulgaria827 participantsStarted 2023-11-27
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, emerg…
What they're measuring
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)