In trials with more than 10,000 patients, BREZTRI had a safety profile comparable with LAMA/LABA and ICS/LABA.1*
Adverse reactions occurring at an incidence of ≥2% of patients and more common in BREZTRI compared to LAMA/LABA and ICS/LABA (Study 1)1
In 24-week data from Study 2, adverse reactions that occurred in patients treated with BREZTRI 320/18/9.6 mcg (n=639) at an incidence of ≥2% included dysphonia (3.3%) and muscle spasms (3.3%).
*2783 patients with COPD received at least 1 dose of BREZTRI 320/18/9.6 mcg.
Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap.1
Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids.1
BREZTRI SHOWED LOW PNEUMONIA IN CLINICAL TRIALS IN PATIENTS WITH COPD1
Study 1: Incidence of confirmed pneumonia (52 weeks)1
(Patients with moderate to very severe COPD, with ≥1 moderate or severe exacerbation in the last year)1
BREZTRI — 4.2% |
ICS/LABA — 4.5% |
LAMA/LABA — 2.3%
Study 2: Incidence of confirmed pneumonia (24 weeks)1
(Patients with moderate to very severe COPD, majority with no history of moderate or severe exacerbations within the last year)3
BREZTRI — 1.9% |
ICS/LABA — 1.9% |
LAMA/LABA — 1.6%
BREZTRI is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
†Fixed-dose combination: ICS/LAMA/LABA.