Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
ConditionAsthma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChiesi Farmaceutici S.p.A.
About this trial
This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant. We want to make sure both versions of the inhaler work the same way for people with mild to moderate asthma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female adults (18 ≤ age ≤ 75 years) with a diagnosis of Asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years;
Non-smokers, ex-smokers;
Body mass index: within the range of 18.0 to 35.0 kg/m2 inclusive;
low or medium doses of ICS (Inhaled Corticosteroids) alone; or
Disqualifiers
History of near fatal asthma or hospitalisation for asthma in intensive care unit, inpatient setting or emergency room access for asthma in the previous 6 months prior to screening, which in the judgement of the Investigator may place the subjects at undue risk;
Recent asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation within 3 months prior to screening and/or during the run-in period ;
Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine;
High dose ICS;
Trial design
Design model
Crossover
Treatments tested in this trial
CHF5993 pMDI with HFA-152a
Drugtwo puffs BID (twice daily)
CHF5993 pMDI with HFA-134a
Drugtwo puffs BID
CHF718 pMDI with HFA-134a
Drugtwo puffs BID
Treatment groups
780 Participants
are divided into 3 treatment groupsGroup A: Test Treatment: CHF5993 pMDI (Pressurised Metered Dose Inhaler) with HFA-152aExperimental treatment 1 intervention
Group B: Reference Treatment 1: CHF5993 pMDI with HFA-134aActive comparator 1 intervention
Group C: Reference Treatment 2: CHF718 pMDI with HFA-134aActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from time zero to 4 hours (AUC0-4h) on Day 1
Time frame
Day 12
Change from baseline in pre-dose FEV1 on Day 28
Time frame
Day 28Sponsors and contacts
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Source ClinicalTrials.gov