Breztri Aerosphere now available for long-term maintenance treatment of COPD

AstraZeneca is introducing Breztri Aerosphere, a pressurized metered-dose inhaler containing budesonide 182 µg, glycopyrronium 8.2 µg (as bromide) and formoterol fumarate dihydrate 5.8 µg per metered actuation. The triple-therapy product is indicated for long-term maintenance treatment to reduce exacerbations of chronic obstructive pulmonary disease (COPD) and treat airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.1,2 Breztri Aerosphere is intended for patients who are not adequately controlled by a combination of an inhaled corticosteroid (ICS)/long-acting beta2-adrenergic agonist (LABA) or a combination of a long-acting muscarinic antagonist (LAMA)/LABA. The product is not indicated for the treatment of acute episodes of bronchospasm or asthma.1 Read: Top 10 takeaways from the latest Canadian data on long-COVID Breztri Aerosphere contains an ICS (budesonide) and two bronchodilators (glycopyrronium [a LAMA] and formoterol fumarate dihydrate [a LABA]). The different mechanisms of action of these three drugs results in increased efficacy compared to any of the dual component therapies. The product has a rapid onset of action, within five minutes of the first dose.1 The recommended dosage is two inhalations twice daily (morning and evening). Patients should be counselled to use the product regularly, even when asymptomatic, to achieve optimum benefit. They should also be advised to rinse the mouth with water after each dose (and spit it out) to help reduce the risk of oropharyngeal candidiasis. Patients who have been taking a rapid onset, short duration, inhaled beta2-agonist (e.g., salbutamol) on a regular basis should discontinue its regular use and use it only for symptomatic relief if they develop acute respiratory symptoms while taking Breztri.1 Health Canada's approval of Breztri Aerosphere was based on positive results from ETHOS and KRONOS phase III trials in patients with moderate to very severe COPD. In the ETHOS trial, Breztri Aerosphere showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies (glycopyrronium/formoterol fumarate, and budesonide/formoterol fumarate) over 52 weeks. In the KRONOS trial, which included patients with no history of exacerbations in the prior 12 months, Breztri Aerosphere demonstrated a statistically significant reduction in the rate of moderate or severe exacerbation over 24 weeks compared with dual-combination therapy (glycopyrronium/formoterol fumarate).2 In a press release accompanying the launch of Breztri, Dr. Jean Bourbeau, Respirologist and Professor in the Departments of Medicine and Epidemiology & Biostatistics at McGill University commented that "Preventing exacerbations is a key clinical priority, as even a single exacerbation can cause further deterioration of a patient's lung function, increase the risks of hospitalization and premature death. Triple fixed-dose combination therapies, like Breztri Aerosphere, have demonstrated benefits in reducing exacerbations and mortality for eligible patients and represent an important advance in the field."2 Read: Health Canada approves Ryaltris for Seasonal Allergic Rhinitis Breztri Aerosphere is supplied as a pressurized inhalation suspension in a meter-dose inhaler (with dose indicator) containing 56 actuations (hospitals or samples) or 120 actuations (retail). Patients should be encouraged to store the device in a dry place between 15°C–30°C. After opening the foil pouch, the inhaler should be used within six weeks for the 56-actuation inhaler or three months for the 120-actuation inhaler.1 Breztri Aerosphere is the second “triple-therapy” (ICS/LAMA/LABA) combination approved for use in COPD, following GlaxoSmithKline’s Trelegy Ellipta (fluticasone furoate 100 µg/umeclidinium 62.5 µg/vilanterol 25 µg). Trelegy Ellipta is supplied in a dry powder inhaler, with a dosage of one inhalation once daily.3 References 1. AstraZeneca Canada Inc. Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension) product monograph. Mississauga, ON; September 30, 2021.(accessed October 27, 2022). 2. AstraZeneca Canada Inc. Breztri Aerosphere now available in Canada for long-term maintenance treatment of COPD. October 24, 2022. (accessed October 27, 2022). 3. GlaxoSmithKline Inc. Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol dry powder for oral inhalation) product monograph. Mississauga, ON; January 17, 2022. (accessed October 27, 2022).

Breztri Aerosphere now available for long-term maintenance treatment of COPD

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