FDA Clears Breztri for Asthma Use - Scorecard - MDSpire

FDA Clears Breztri for Asthma Use

  • By

  • Kathryn Wighton

  • April 28, 2026

  • 2 min

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Clinical Scorecard: FDA Clears Breztri for Asthma Use

At a Glance

CategoryDetail
ConditionAsthma
Key MechanismsFixed-dose triple-combination inhaled therapy combining inhaled corticosteroid, long-acting beta2-agonist, and long-acting muscarinic antagonist
Target PopulationPatients aged 12 years and older with asthma
Care SettingMaintenance treatment in outpatient settings

Key Highlights

  • Approved for maintenance treatment of asthma in patients aged 12 years and older
  • Demonstrated improved lung function compared with inhaled corticosteroid/long-acting beta2-agonist therapy in Phase 3 KALOS and LOGOS trials
  • Rapid onset of action with lung function improvements within 5 minutes of initial dose

Guideline-Based Recommendations

Diagnosis

  • Asthma diagnosis based on clinical presentation including symptoms such as wheezing, dyspnea, chest tightness, and exacerbations

Management

  • Use Breztri (budesonide/glycopyrrolate/formoterol fumarate) as maintenance therapy for asthma patients aged 12 years and older
  • Not intended for relief of acute bronchospasm or as a substitute for rescue inhalers

Monitoring & Follow-up

  • Monitor lung function improvements over 12 to 24 weeks
  • Assess for asthma control and exacerbation frequency

Risks

  • No new safety or tolerability concerns identified in clinical trials

Patient & Prescribing Data

Approximately 4,300 randomized asthma patients aged 12 years and older, including those with and without recent exacerbations

Improved forced expiratory volume in 1 second and trough lung function compared to dual therapy; rapid onset of action; suitable for maintenance but not acute symptom relief

Clinical Best Practices

  • Incorporate triple-combination inhaled therapy for patients inadequately controlled on dual maintenance therapy
  • Continue to use rescue inhalers for acute bronchospasm
  • Educate patients on the role of maintenance therapy versus rescue treatment
  • Regularly assess lung function and symptom control to guide therapy adjustments

References

Original Source(s)

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