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Safety profile established in pivotal trials encompassing 10,405 patients1

The overall safety profile of BREZTRI AEROSPHERE was generally consistent with the known pharmacologic class effects of ICSs, LAMAs and/or LABAs.

Adverse drug reactions in the ETHOS 52-week trial occurring in ≥2% of patients, any treatment group (BREZTRI AEROSPHERE, n=2,144; GFF MDI, n=2,125; BFF MDI; n=2,136)

Headache (BREZTRI AEROSPHERE, 2.7%; GFF MDI, 2.8%; BFF MDI, 3.2%), cough (BREZTRI AEROSPHERE, 2.7%; GFF MDI, 2.4%; BFF MDI, 2.4%), muscle spasms (BREZTRI AEROSPHERE, 2.8%; GFF MDI, 0.9%; BFF MDI, 2.5%), oral candidiasis (BREZTRI AEROSPHERE, 3.0%; GFF MDI, 1.1%; BFF MDI, 2.7%), pneumonia (BREZTRI AEROSPHERE, 4.6%; GFF MDI, 2.9%.; BFF MDI, 5.0%), urinary tract infection (BREZTRI AEROSPHERE, 2.7%; GFF MDI, 2.8%; BFF MDI, 1.9%)

Pneumonia

In the 52-week ETHOS trial, the incidence of confirmed pneumonia was:1

BREZTRI AEROSPHERE

GFF MDI

BFF MDI

4.2%

2.3%

4.5%

In the 24-week KRONOS trial, the incidence of confirmed pneumonia was low and similar across treatment groups1

BREZTRI AEROSPHERE

GFF MDI

BFF MDI

1.9%

1.6%

1.9%

BFF: budesonide/formoterol fumarate dihydrate; GFF: glycopyrronium/formoterol fumarate dihydrate; ICS: inhaled corticosteroid; LABA: long-acting beta2-adrenergic agonist; LAMA: long-acting muscarinic antagonist; MDI: metered-dose inhaler.

Reference:

  1. BREZTRI AEROSPHERE Product Monograph. AstraZeneca Canada Inc.
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