Breztri Aerosphere Adverse Reactions

Summary of the safety profile: The safety profile is characterised by corticosteroid, anticholinergic and β2-adrenergic class effects related to the individual components of the combination. The most commonly reported adverse reactions in patients receiving this medicinal product were pneumonia (4.6%), headache (2.7%) and urinary tract infection (2.7%).
Tabulated list of adverse reactions: The tabulated list of adverse reactions is based on the experience with this medicinal product in clinical trials and experience with the individual components.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data). (See Table 3.)

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Description of selected adverse reactions: Pneumonia: KRONOS was a 24-week study in a total of 1,896 patients with moderate to very severe COPD (mean post-bronchodilator screening FEV1 50% of predicted, standard deviation [SD] 14%), 26% of whom had experienced a COPD exacerbation in the year prior to study entry. The incidence of confirmed pneumonia events reported up to 24 weeks was 1.9% (12 patients) for Budesonide/Glycopyrronium/Formoterol Fumarate (Breztri Aerosphere) (n=639), 1.6% (10 patients) for formoterol fumarate dihydrate/glycopyrronium (FOR/GLY) MDI 5/7.2 micrograms (n=625), 1.9% (6 patients) for formoterol fumarate dihydrate/budesonide (FOR/BUD) MDI 5/160 micrograms (n=314) and 1.3% (4 patients) for open-labelled formoterol fumarate dihydrate/budesonide Turbuhaler (FOR/BUD) TBH 6/200 micrograms (n=318). In KRONOS, there were no fatal cases of pneumonia with Budesonide/Glycopyrronium/Formoterol Fumarate (Breztri Aerosphere).
ETHOS was a 52-week study in a total of 8,529 patients (in the safety population) with moderate to very severe COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 43% of predicted, SD 10%). The incidence of confirmed pneumonia was 4.2% (90 patients) for Budesonide/Glycopyrronium/Formoterol Fumarate (Breztri Aerosphere) (n=2144), 3.5% (75 patients) for formoterol fumarate dihydrate/glycopyrronium/budesonide (FOR/GLY/BUD) MDI 5/7.2/80 micrograms (n=2124), 2.3% (48 subjects) for FOR/GLY MDI 5/7.2 micrograms (n=2125) and 4.5% (96 subjects) FOR/BUD MDI 5/160 micrograms (n=2136). In ETHOS, there were five fatal cases of pneumonia during the treatment phase of the study (two with FOR/GLY/BUD MDI 5/7.2/80, three with FOR/GLY MDI and none with Budesonide/Glycopyrronium/Formoterol Fumarate (Breztri Aerosphere)).