New inhaler propellant clears lungs as well as current version, paving climate shift
A clinical trial shows that a climate-friendly propellant for inhalers performs identically to the standard version in clearing mucus from airways. The finding clears a major regulatory hurdle for manufacturers to switch to lower-emission inhalers—a shift that could cut pharmaceutical emissions without compromising patient care.
Originaltitel: Mucociliary Clearance Following a Next-Generation Propellant Versus Hydrofluoroalkane-134a via Pressurized Metered-Dose Inhaler: A Randomized, Double-Blind, Two-Way Crossover Study in Healthy Adults.
Övergång till klimatvänligare inhalatörer blir regulatoriskt genomförbar. Ny studie bekräftar att propellanten HFO-1234ze, som har 99 procent lägre växthusgaspotential än dagens standard HFA-134a, inte påverkar lungors mukociliär clearance negativt. Försöket omfattade 34 deltagare som inhalarerade båda propellanterna under två perioder à sju dagar. Vid 60 minuter skilde sig effekten på mukociliär clearance marginellt mellan HFO-1234ze och HFA-134a (−1,4 procent; 95 procent konfidensintervall −5,8 till 2,9). Vid tre timmar noterades en statistisk skillnad på −5,7 procent, men utan klinisk relevans. Ingen oväntad säkerhetssignaler registrerades. AstraZeneca och University of North Carolina genomförde studien för att stödja registrering av HFO-1234ze-baserade pMDI:er. För inköpschefer och läkemedelsmyndigheter bekräftas nu att miljöbyte inte kräver dosförändring eller omprovning av terapin.
BACKGROUND: Pressurized metered-dose inhalers (pMDIs) are commonly used for respiratory disease treatment but contain propellants, such as hydrofluoroalkane-134a (HFA-134a), with global warming potential (GWP) that contribute to the climate emergency. To safeguard essential medicine access, it is crucial to transition to lower-GWP propellants, such as hydrofluoroolefin-1234ze (HFO-1234ze), which has 99% lower GWP than HFA-134a. In accordance with global regulatory requirements, this study was conducted to support the registration of pMDIs with HFO-1234ze. METHODS: This randomized, double-blind, multicenter, two-way crossover study assessed the effects of HFO-1234ze versus HFA-134a on mucociliary clearance (MCC) in healthy participants aged 18-60 years. Participants received six inhalations twice daily of HFO-1234ze and HFA-134a in two 7-day (+3) intervention periods separated by a 7- to 14-day washout. The primary and secondary endpoints were change from period-specific baseline in average whole lung MCC (%) through 60 minutes (MCC60) and at 3 hours (MCC3h), respectively, measured via inhalation of RESULTS: Forty-five participants were screened; the Primary Analysis Set included 34 participants who completed both intervention periods. For the primary endpoint, change from period-specific baseline in MCC60 was negligible, with an estimated change (95% confidence interval [CI]) of -0.6% (-3.2%, 1.9%) for HFO-1234ze and 0.8% (-1.7%, 3.3%) for HFA-134a. The estimated least-squares mean difference (95% CI) between HFO-1234ze and HFA-134a was -1.4% (-5.8%, 2.9%). For the secondary endpoint, the estimated least-squares mean difference for change from period-specific baseline in MCC3h between HFO-1234ze and HFA-134a was -5.7% (-10.9%, -0.5%). There were no unexpected safety findings. CONCLUSION: There was no clinically relevant impact of HFO-1234ze versus HFA-134a on MCC in healthy participants. CLINICAL TRIAL REGISTRATION NUMBER: NCT05755932.