High Dose Extrafine Beclomethasone/Formoterol Via Metered Dose Inhaler is Effective and Safe in Asthmatics Not Controlled on Medium-High Dose of Inhaled Corticosteroids

A fixed combination of beclomethasone/formoterol (BDP/FF) delivered via pressurised metered dose inhaler (pMDI), containing a high dose of extrafine BDP (200 μg/actuation) and FF (6 μg/actuation) has been developed to treat asthmatics not adequately controlled on previous treatments. This was a phase III, randomised, double-blind, three-month trial designed to demonstrate the superiority of this high dose fixed combination of BDP/FF, 2 puffs twice daily (800/24μg total daily dose), versus extrafine BDP (100μg), 4 puffs twice daily (800μg total daily dose), in adult asthmatics. The primary endpoint was the change from baseline over the entire treatment period in average pre-dose morning PEF. The ITT population included 359 asthmatic patients (FEV1 64% of predicted) not adequately controlled (ACQ>0.75) with high dose of inhaled corticosteroids (ICS) or medium dose of ICS plus long acting beta agonist (LABA). The superiority of BPD/FF over BDP monotherapy was demonstrated with an adjusted mean difference of 19 L/min in pre-dose morning PEF, which is above the minimal important clinical difference for this parameter. The safety profile of the two treatments was comparable, however, while BDP/FF did not seem to affect the hypothalamus-pituitary-adrenal axis, BDP was found to slightly reduce serum cortisol levels. The study successfully showed that BDP/FF 200/6 μg significantly improves lung function compared to BDP alone and, thus, this high dose treatment option can be considered as an effective and safe treatment for asthmatics not adequately controlled with high doses of ICS monotherapy or medium doses of ICS/LABA.