Clinical Data for Asthma

Explore the Efficacy of BREZTRI for ASTHMA

KALOS & LOGOS Primary endpoints1-3

In the primary analysis of two replicate studies, BREZTRI significantly improved FEV1 AUC0-3 vs ICS/LABA* by 68 mL (P=0.0006) in KALOS and by 134 mL (P<0.0001) in LOGOS at Week 24.2,3

In the pooled primary analysis of KALOS and LOGOS, a 10% reduction in annualized rate of severe exacerbations was observed with BREZTRI versus ICS/LABA* (RR: 0.90; 95% CI: 0.78, 1.03; P=0.12).1,3

*ICS/LABA refers to BUD/FORM 320/9.6 mcg administered twice daily via Aerosphere device.

SYMBICORT (budesonide/formoterol fumarate dihydrate) Indications and Important Safety Information

  • Use of long-acting beta2-adrenergic agonists (LABA) as monotherapy (without inhaled corticosteroids [ICS]) for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA. When LABA are used in fixed dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to ICS alone

  • SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms

  • SYMBICORT should not be initiated in patients during rapidly deteriorating episodes of asthma or COPD

  • Patients who are receiving SYMBICORT should not use additional formoterol or other LABA for any reason

  • Localized infections of the mouth and pharynx with Candida albicans has occurred in patients treated with SYMBICORT. Patients should rinse the mouth after inhalation of SYMBICORT

  • Lower respiratory tract infections, including pneumonia, have been reported following the administration of ICS

  • Due to possible immunosuppression, potential worsening of infections could occur. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients

  • It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to ICS. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available ICS

  • Caution should be exercised when considering administration of SYMBICORT in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors

  • As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT

  • Immediate hypersensitivity reactions may occur, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm

  • Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension

  • Long-term use of ICS may result in a decrease in bone mineral density (BMD). Since patients with COPD often have multiple risk factors for reduced BMD, assessment of BMD is recommended prior to initiating SYMBICORT and periodically thereafter

  • ICS may result in a reduction in growth velocity when administered to pediatric patients

  • Glaucoma, increased intraocular pressure, and cataracts have been reported following the administration of ICS, including budesonide, a component of SYMBICORT. Close monitoring is warranted in patients with a change in vision or history of increased intraocular pressure, glaucoma, or cataracts

  • In rare cases, patients on ICS may present with systemic eosinophilic conditions

  • SYMBICORT should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines

  • Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients

  • The most common adverse reactions ≥3% reported in asthma clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, pharyngitis, rhinitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis

  • The most common adverse reactions ≥3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection

  • SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents

  • Beta-blockers may not only block the pulmonary effect of beta-agonists, such as formoterol, but may produce severe bronchospasm in patients with asthma

  • ECG changes and/or hypokalemia associated with nonpotassium-sparing diuretics may worsen with concomitant beta-agonists. Use caution with the coadministration of SYMBICORT

INDICATIONS

SYMBICORT is indicated for the treatment of asthma in patients 6 years and older not adequately controlled on a long-term asthma-control medication such as an ICS or whose disease warrants initiation of treatment with both an ICS and LABA. (also see DOSAGE AND ADMINISTRATION).

SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and to reduce COPD exacerbations.

SYMBICORT is NOT indicated for the relief of acute bronchospasm.

Please see full Prescribing Information, including Patient Information

You may report side effects related to AstraZeneca products.

Asthma Clinical Trial Data Chart Showing Reduction in Exacerbation Rates with Triple Therapy Compared to ICS LABA Treatment
Asthma Clinical Trial Data Chart Showing Reduction in Exacerbation Rates with Triple Therapy Compared to ICS LABA Treatment

Click to see SYMBICORT® (budesonide/
formoterol fumarate dihydrate) Inhalation Aerosol Indications and Important Safety Information. See full SYMBICORT Prescribing Information.

BREZTRI IS THE ONLY TRIPLE THERAPY* TO DEMONSTRATE BETTER
BREATHING FAST1-5

Plus_Icon
KALOS And LOGOS Clinical Trial Data for Asthma Showing Improvement in Lung Function Measured by FEV1 with Triple Therapy
KALOS And LOGOS Clinical Trial Data for Asthma Showing Improvement in Lung Function Measured by FEV1 with Triple Therapy

*Fixed-dose combination: ICS/LAMA/LABA.

†These data are pooled and descriptive.

BREZTRI DEMONSTRATED IMPROVEMENT IN FEV1 AT 5 MINUTES ON DAY 11,3,6

KALOS And LOGOS Asthma Clinical Trial Chart Showing FEV1 Improvement on Day 1 Comparing Triple Therapy with ICS LABA
KALOS And LOGOS Asthma Clinical Trial Chart Showing FEV1 Improvement on Day 1 Comparing Triple Therapy with ICS LABA

In a combined data set from a lung function substudy
of KALOS and LOGOS, 74% OF PATIENTS FELT BREZTRI WORKING WITHIN 5 MINUTES ON DAY 1 as assessed by the OEQ in clinic6†

In the pooled KALOS/LOGOS trial analysis, LS mean change from baseline FEV1 was 132 mL in the SYMBICORT arm (95% Cl: 121, 144)3‡

*Estimate (Cl), pooled efficacy set.

†Onset of Effect Questionnaire item "Can you feel your medication working?" perceivers defined as patients responding yes to the OEQ item.

‡Pooled onset of action analyses are not part of multiple testing procedure. The analysis was performed using a within-group T-test to demonstrate that the LS mean change from baseline in FEV1 at 5 minutes post dose is statistically greater than 100 mL.

BUD/FORM(A)=budesonide/formoterol fumarate Aerosphere; FEV1=forced expiratory volume in 1 second; ICS=inhaled corticosteroid; LS=least square; OEQ=Onset of Effect Questionnaire.

KALOS & LOGOS Study Designs1,2

The KALOS and LOGOS studies were two randomized, double-blind, double-dummy, parallel-group, multicenter, 24- to 52-week variable-length studies assessing the efficacy and safety of BREZTRI compared with BUD/FORM. Participants with inadequately controlled asthma despite ICS/LABA use were randomized (pooled N=4311) to BREZTRI 320/36/9.6 μg (n=1179), BUD/FORM 320 mg (n=1192), and BUD/FORM(A) (n=1208), each administered BID via pressurized metered-dose inhaler for 24 to 52 weeks. Patients were 12-80 years of age, with a smoking history of <10 pack-years. Primary and key secondary lung function endpoints included change from baseline in FEV1 AUC0-3 at 24 weeks, change from baseline in morning predose trough FEV1 at 24 weeks, and onset of action (change in FEV1) at 5 minutes post dose on Day 1. The primary pooled endpoint across studies was annualized rate of severe exacerbations. A severe asthma exacerbation was defined as a course of SCS for ≥3 consecutive days, an ER or urgent care visit or an inpatient hospitalization requiring SCS, or death.

SYMBICORT is a registered trademark of the AstraZeneca group of companies.

AUC0-3=area under the curve from 0 to 3 hours; BID=twice daily; BUD=budesonide; BUD/FORM(A)=budesonide/formoterol fumarate Aerosphere; CI=confidence interval; ER=emergency room; FEV1=forced expiratory volume in 1 second; FORM=formoterol fumarate; ICS=inhaled corticosteroid; LABA=long-acting beta2-adrenergic agonist; RR=rate ratio; SCS=systemic corticosteroid.

Order Samples
Learn About Safety

Important Safety Information

IMPORTANT SAFETY INFORMATION

  • BREZTRI is contraindicated:
    • For the primary treatment of status asthmaticus or other acute episodes of asthma or COPD requiring intensive measures
    • In patients who have a hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate or product excipients
  • Long-acting beta2-adrenergic agonist (LABA) monotherapy for asthma is associated with an increased risk of serious asthma-related events. These findings are considered a class effect of LABA monotherapy. When a LABA is used in a fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS use alone. Available data do not suggest an increased risk of death with use of LABA in patients with COPD
  • BREZTRI should not be initiated in patients with acutely deteriorating COPD or asthma, which may be a life-threatening condition
  • BREZTRI is NOT a rescue inhaler. Do NOT use to relieve acute symptoms; treat with an inhaled short-acting beta2-agonist
  • BREZTRI should not be used more often than recommended; at higher doses than recommended; or in combination with LABA-containing medicines, due to risk of overdose. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs
  • Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing budesonide. Advise patients to rinse their mouths with water without swallowing after inhalation
  • Lower respiratory tract infections, including pneumonia, have been reported following ICS. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap
  • Due to possible immunosuppression, potential worsening of infections could occur. Use with caution. A more serious or fatal course of chickenpox or measles can occur in susceptible patients
  • Particular care is needed for patients transferred from systemic corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to BREZTRI
  • Hypercorticism and adrenal suppression may occur with regular or very high dosage in susceptible individuals. If such changes occur, consider appropriate therapy
  • Caution should be exercised when considering the coadministration of BREZTRI with long-term ketoconazole and other known strong CYP3A4 Inhibitors. Adverse effects related to increased systemic exposure to budesonide may occur
  • If paradoxical bronchospasm occurs, discontinue BREZTRI immediately and institute alternative therapy
  • Anaphylaxis and other hypersensitivity reactions (eg, angioedema, urticaria or rash) have been reported. Discontinue and consider alternative therapy
  • Use caution in patients with cardiovascular disorders, especially coronary insufficiency, as formoterol fumarate can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles
  • Decreases in bone mineral density have been observed with long-term administration of ICS. Assess initially and periodically thereafter in patients at high risk for decreased bone mineral content
  • Monitor growth in pediatric patients
  • Glaucoma and cataracts may occur with long-term use of ICS. Worsening of narrow-angle glaucoma may occur, so use with caution. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use BREZTRI long term. Instruct patients to contact a healthcare provider immediately if symptoms occur
  • Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if symptoms occur
  • Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis or unusually responsive to sympathomimetic amines
  • Be alert to hypokalemia or hyperglycemia
  • Most common adverse reactions (incidence ≥ 2%) are:
    • COPD: upper respiratory tract infection, pneumonia, back pain, oral candidiasis, influenza, muscle spasms, urinary tract infection, cough, sinusitis, and diarrhea
    • Asthma: nasopharyngitis, pneumonia, and headache
  • BREZTRI should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors and tricyclic antidepressants, as these may potentiate the effect of formoterol fumarate on the cardiovascular system
  • BREZTRI should be administered with caution to patients being treated with:
    • Strong cytochrome P450 3A4 inhibitors (may cause systemic corticosteroid effects)
    • Adrenergic drugs (may potentiate effects of formoterol fumarate)
    • Xanthine derivatives, steroids, or non-potassium sparing diuretics (may potentiate hypokalemia and/or ECG changes)
    • Beta-blockers (may block bronchodilatory effects of beta-agonists and produce severe bronchospasm)
    • Anticholinergic-containing drugs (may interact additively). Avoid use with BREZTRI
  • Use BREZTRI with caution in patients with hepatic impairment, as budesonide and formoterol fumarate systemic exposure may increase. Patients with severe hepatic disease should be closely monitored

INDICATIONS

BREZTRI AEROSPHERE 160 mcg/9 mcg/4.8 mcg is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

BREZTRI AEROSPHERE 160 mcg/18 mcg/4.8 mcg is indicated for the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older.

LIMITATIONS OF USE

Not indicated for the relief of acute bronchospasm.

Please see full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products.

Important Safety Information

 +

References

  • 1.BREZTRI AEROSPHERE® (budesonide, glycopyrrolate, and formoterol fumarate) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026.

  • 2.Papi A, Wise RA, Jackson DJ, et al. Budesonide-glycopyrronium-formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials.Lancet Respir Med. 2026;14(4):350-362. doi:10.1016/S2213-2600(25)00457-6

  • 3.Papi A, Wise RA, Jackson DJ, et al. Budesonide-glycopyrronium-formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials. Lancet Respir Med. 2026;14(suppl):1-116. doi:10.1016/S2213-2600(25)00457-6

  • 4.Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; 2023.

  • 5.Trimbow® U.S. (beclomethasone dipropionate, formoterol fumarate, and glycopyrrolate) [prescribing informaiton]. Cary, NC: Chiesi USA, Inc; 2026.

  • 6.Lugogo NL, Wise RA, Papi A, et al. Lung function benefits of budesonide/ glycopyrrolate/formoterol fumarate triple therapy for the treatment of inadequately controlled asthma: KALOS and LOGOS study results. Presented at: CHEST Annual Meeting; October 19-22, 2025; Chicago, IL.

This product information is intended for US Healthcare Professionals only.

BREZTRI AEROSPHERE is a registered trademark of the AstraZeneca group of companies.

©2026 AstraZeneca. All rights reserved. US-102140; US-106667; US-110378; US-112026 Last Updated 6/26