Triple vs. dual therapy for COPD

The Global Initiative for the Treatment of Obstructive Pulmonary Disease (GOLD) recommends triple therapy with inhaled corticosteroids, long-acting beta agonists (LABA), and long-acting anticholinergic agents (LAMA). And the studies show that triple therapy with one inhaler is no better than the same treatment with three separate inhalers. Convenience is the main benefit of taking the three medicines together. Simpler dosing can help people stick to their treatment plans and not miss dosing.

The acquisition by AstraZeneca of Pearl Therapeutics in June 2013, where AstraZeneca acquired a 100% stake in Pearl has enabled AstraZeneca to take advantage of a new treatment, inhalation and formulation technologies for COPD, providing a platform for future combination products.

Bevespi Aerosphere (PT010) was approved in US and Europe in 2020 for COPD maintenance therapy. AstraZeneca holds various patents of Bevespi Aerosphere that are expected to expire between 2030 and 2031 in the US and in 2030 in the EU, China, and Japan.

ETHOS study Trial 1 (NCT02465567) turned into performed over 52 weeks in a complete of 8,588 people randomized (1:1:1:1) to get hold of Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate 320 mcg/18 mcg/9.6 mcg), budesonide, glycopyrrolate and formoterol fumarate [BGF MDI 160 mcg/18 mcg/9.6 mcg], glycopyrrolate and formoterol fumarate [GFF MDI 18 mcg/9.6 mcg], or budesonide and formoterol fumarate [BFF MDI 320 mcg/9.6 mcg], all administered two times daily. GFF MDI and BFF MDI used the identical inhaler and excipients as Breztri Aerosphere.

In Trial 2 (NCT02497001) received budesonide / glycopyrrolate / formoterol fumarate 320 mcg / 18 mcg / 9.6 mcg, glycopyrrolate over a 24-week period, with a total of 1,896 patients and formoterol. It was randomized to be administered (2: 2: 1: 1). Fumarate [GFFMDI 18 mcg / 9.6 mcg], budesonide and formoterol fumarate [BFF MDI 320 mcg / 9.6 mcg] or open-label active comparator, all given twice daily. GFFMDI and BFFMDI used the same inhalers and excipients as Breztri Aerosphere. The drug showed an increase in AUC04 for FEV1 during treatment at week 24 compared to BFF-MDI and an increase in mean change in pre-dose trough FEV1 in the morning at week 24 compared to GFF-MDI.

In both the trial age, gender, degree of airflow restriction (moderate, severe, and very severe), and patient subgroups classified by previous ICS use showed consistent improvement in lung function.

At the American Thoracic Society (ATS) International Conference 2022, AstraZeneca presented post-hoc analysis explored the effects of BGF versus GFF and BFF on exacerbations of COPD in current and former smokers in the ETHOS study this post-hoc analysis assesses the annual rate of moderate or severe exacerbations and the annual rate of severe exacerbations in a subgroup of patients defined by smoking status at randomization using a modified treatment intent (mITT) population. Of 8509 patients included in the mITT population, 3495 were current smokers and 5014 were former smokers.

BGF 320 was observed to reduce the annual incidence of moderate or severe exacerbations compared to dual therapy with GFF or BFF, regardless of smoking status. The annual rate of severe exacerbations was also lower with BGF320 than with dual therapy.

As per Delveinsight analysis, triple therapy appears to reduce the number of relapses and improve the quality of life over dual therapy in patients with COPD. However, it can increase the risk of side effects.

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