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FDA approved Breztri Aerosphere (budesonide/glycopyrrolate/formoterol) for COPD MaintenanceFDA approved new triple-combination inhaler Breztri Aerosphere for COPD.

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Key Takeaway
Consider Breztri Aerosphere for maintenance treatment of COPD in patients requiring triple therapy with ICS, LAMA, and LABA.

The FDA has approved Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The triple-combination inhaler contains an inhaled corticosteroid (ICS), an anticholinergic, and a long-acting beta2-agonist (LABA). It is not indicated for relief of acute bronchospasm or for asthma. The approval was supported by two randomized, double-blind trials in patients with moderate to very severe COPD. In Trial 1, Breztri Aerosphere reduced the rate of moderate or severe exacerbations compared with glycopyrrolate/formoterol and budesonide/formoterol. The recommended dose is two inhalations twice daily. Clinicians should note the need for priming and mouth rinsing after use.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Budesonide is an inhaled corticosteroid (ICS) with anti-inflammatory activity. Glycopyrrolate is an anticholinergic that inhibits muscarinic receptors in bronchial smooth muscle, leading to bronchodilation. Formoterol fumarate is a long-acting beta2-adrenergic agonist (LABA) that relaxes bronchial smooth muscle.

Indication & Patient Population

Breztri Aerosphere is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: Not indicated for relief of acute bronchospasm or for treatment of asthma.

Dosing & Administration

For oral inhalation only. Recommended dosage: 2 inhalations of Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate 160 mcg/9 mcg/4.8 mcg per inhalation) twice daily (morning and evening). Do not exceed 2 inhalations twice daily. Rinse mouth with water after inhalation without swallowing. Prime before first use by releasing 4 sprays into the air, shaking well before each spray. If not used for more than 7 days, dropped, or after weekly rinsing, re-prime with 2 sprays.

Key Clinical Trial Data

Trial 1 (NCT02465567): 52-week, randomized, double-blind, multicenter, parallel-group trial in 8,588 subjects with moderate to very severe COPD and a history of 1+ moderate or severe exacerbations in the prior year. Subjects received Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate 320 mcg/18 mcg/9.6 mcg), glycopyrrolate/formoterol (GFF MDI 18 mcg/9.6 mcg), or budesonide/formoterol (BFF MDI 320 mcg/9.6 mcg) twice daily. Primary endpoint: rate of moderate or severe COPD exacerbations for Breztri Aerosphere vs GFF MDI and BFF MDI. Trial 2 (NCT02497001): 24-week trial in 1,896 subjects with similar design.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Breztri Aerosphere is a triple-combination maintenance therapy for COPD. It is not for acute bronchospasm or asthma. It may be considered for patients requiring ICS/LAMA/LABA combination therapy.

The FDA has approved a new inhaler called Breztri Aerosphere for the maintenance treatment of chronic obstructive pulmonary disease (COPD). This medicine combines three different drugs in one inhaler: a corticosteroid to reduce inflammation, an anticholinergic to relax airways, and a long-acting beta2-agonist (LABA) to help keep airways open. It is meant for people with moderate to very severe COPD who need daily treatment to prevent flare-ups.

Breztri Aerosphere is not for sudden breathing problems or for asthma. It should be used exactly as prescribed, typically two puffs twice a day. The approval was based on studies showing that it reduced the number of moderate or severe COPD flare-ups compared to other combinations.

This approval offers a new option for people with COPD. However, it is important to remember that this medicine is not a rescue inhaler. Patients should continue to use their rescue inhaler for sudden symptoms. Also, after using Breztri Aerosphere, you should rinse your mouth with water to help prevent thrush (a mouth infection).

If you have COPD, talk to your doctor about whether Breztri Aerosphere might be right for you. Your doctor can help you understand the benefits and risks based on your specific health needs.

What this means for you:
Breztri Aerosphere is a new daily inhaler for COPD, not for sudden symptoms or asthma.

Study Details

Study typeFda approval
PublishedJul 2020
View Original Abstract ↓
1 INDICATIONS AND USAGE BREZTRI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: BREZTRI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1 , 5.2) ] . BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta 2 -adrenergic agonist (LABA), indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1) Limitations of Use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma. (1 , 5.1 , 5.2)
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