AstraZeneca Publishes Phase III Data Showing Breztri Benefit in Uncontrolled Asthma

AstraZeneca Publishes Phase III Data Showing Breztri Benefit in Uncontrolled Asthma

By, Admin 16 February 2026

Full Phase III results from the KALOS and LOGOS trials, published in The Lancet Respiratory Medicine, show that Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) demonstrated statistically significant and clinically meaningful improvements in lung function and exacerbation reduction in patients with uncontrolled asthma.

Breztri is a single-inhaler fixed-dose triple therapy combining:

  • Inhaled corticosteroid (ICS)
  • Long-acting beta2-agonist (LABA)
  • Long-acting muscarinic antagonist (LAMA)

It is already approved globally for COPD. Regulatory submissions in asthma are under review.

Clinical Results: What the Data Show

Lung Function (Pooled KALOS + LOGOS)

Compared with dual ICS/LABA therapy:

  • +76 mL improvement in trough FEV1 over 24 weeks
  • +90 mL improvement in FEV1 AUC0-3
  • Both p<0.001

Exacerbations

Breztri reduced the annualized rate of severe asthma exacerbations versus ICS/LABA comparators, including in patients without recent exacerbations.

Approximately 4,300 patients were enrolled across both trials. No new safety signals were identified.

Competitive Context

The trials compared Breztri to dual therapy including:

  • Symbicort
  • PT009 (Aerosphere formulation of budesonide/formoterol)

Symbicort represents a longstanding standard-of-care ICS/LABA therapy. The strategic positioning is clear:

Move triple therapy earlier in the asthma treatment algorithm for patients inadequately controlled on dual therapy.

Why This Matters Strategically?

Asthma affects ~262 million people worldwide. A significant proportion remain uncontrolled despite maintenance dual therapy.

Triple inhaled therapy has been:

  • Standardized in COPD
  • More selectively used in asthma

If approved in asthma, Breztri would:

  • Expand AstraZeneca’s respiratory franchise beyond COPD
  • Extend lifecycle value of an already commercialized asset
  • Compete more directly with other triple combinations and biologics

Importantly, triple therapy offers:

  • Broad mechanism coverage (inflammation + bronchoconstriction + cholinergic tone)
  • An inhaled alternative before escalation to costly biologics

Magnitude of Effect: How Meaningful Is It?

A ~76–90 mL FEV1 improvement is statistically robust. However, key commercial questions include:

  • Is the lung function delta clinically perceptible to patients?
  • How does exacerbation reduction compare to biologics targeting IL-5, IL-4/13 or TSLP?
  • Will guidelines shift triple therapy earlier in moderate disease?

In asthma, biologics have increasingly captured severe uncontrolled populations. Breztri may compete more strongly in:

  • Moderate-to-severe patients
  • Those not yet eligible for biologics
  • Markets sensitive to biologic cost

Lifecycle and Revenue Implications

Breztri is already approved for COPD in:

  • US
  • EU
  • China
  • Japan

It was prescribed to more than 5.5 million patients globally in 2024. Asthma approval would:

  • Expand total addressable market
  • Strengthen Respiratory & Immunology as a growth pillar
  • Leverage established manufacturing and distribution

For AstraZeneca, this is a classic lifecycle expansion strategy: Take a validated COPD triple therapy and reposition it in asthma.

Competitive Landscape

The asthma maintenance space includes:

  • Dual ICS/LABA inhalers
  • LAMA add-on inhalers
  • Triple inhalers
  • Biologics (anti-IL-5, anti-IL-4/13, anti-TSLP)

Breztri’s differentiator:

  • Single-inhaler triple therapy
  • Established COPD safety profile
  • Broad applicability independent of biomarker status

Its main competitive pressure will come from:

  • Other single-inhaler triple therapies
  • Escalation to biologics in severe asthma

Strategic Takeaway

The KALOS and LOGOS data strengthen the case for Breztri in uncontrolled asthma by demonstrating:

  • Statistically significant lung function improvement
  • Exacerbation reduction
  • Clean safety profile

If regulators approve, AstraZeneca gains:

  • A major respiratory label expansion
  • Increased franchise durability
  • A bridge therapy between dual inhalers and biologics

The critical next inflection point will be regulatory decisions across major markets — and how treatment guidelines incorporate triple therapy in asthma.

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