Full results from the positive Phase III KALOS and LOGOS trials published in The Lancet Respiratory Medicine showed AstraZeneca's BREZTRIAerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6mg)) demonstrated statistically significant and clinically meaningful improvements in patients with uncontrolled asthma compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines: Symbicort (budesonide/formoterol fumate or BFF, a standard therapeutic option), PT009 (BFF in an Aerosphere formulation) and the Symbicort and PT009 treatment groups combined. BREZTRIis a single-inhaler, fixed-dose triple-combination of ICS/LABA and a long-acting muscarinic antagonist (LAMA). In a pre-specified pooled analysis of the primary endpoints across the KALOS and LOGOS trials, BREZTRI improved lung function by 76mL (95% CI 57-94 mL, unadjusted p1 over 24 weeks) and 90mL (95% CI 72-108 mL, unadjusted p1 AUC0-3 over 24 weeks) versus dual therapy (the ICS/LABA treatment groups combined).
In the pooled analysis of KALOS and LOGOS, BREZTRI also demonstrated clinically meaningful reductions in the annualized rate of severe asthma exacerbations versus ICS/LABA medicines in patients with or without a recent asthma exacerbation. Full results can be found in The Lancet Respiratory Medicine. Al Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara, and Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, and primary investigator, said: " Many of the 262 million people worldwide living with asthma remain uncontrolled and still struggle with symptoms like frequent breathlessness, coughing and wheezing despite the use of dual maintenance therapy.
The KALOS and LOGOS trial show that the single fixed-dose triple therapy budesonide/glycopynronium/formoterol, which combines the efficacy of an ICS, LAMA, and LABA, improved lung function, and, importantly, prevented future severe exacerbations in patients, regardless of exacerbation history." BREZTRI AEROSPHERE®? (budesonide, glycopyrrolate, and formoterol fumarate) Inhalation Aerosol: BREZTRI is contraindicated in patients who have a hypersensitivity to budesonide, glycopyrrolates, or product excipients; BREZTRI is not indicated for treatment of asthma. Long-acting beta2-adrenergic agonist (LABA) monotherapy for asthma is associated with an increased risk of asthma-related death.
These findings are considered a class effect of LABA monotherapy. When a LABA is used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone. Available data do not suggest an increased risk of death with use of LABA in patients with COPD; BREZTRI should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition; and BREZTRI is NOT a rescue inhaler.
do NOT use to relieve acute symptoms; treat with an inhaled short-acting beta2-agonist; BREZTRI should no be used more often than recommended; at higher doses than recommended; at higher doses of recommended; or in combination with LABA-containing medicines, due to risk of overdose. Clinically significant cardiovascular effects and deaths have been reported in association with excessive use of inhaled sympathomimetic drugs; Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containingbudesonide.
