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NCT04609878 (BREZTRI in Inadequately Controlled Severe Asthma): BVCT ex-ante prediction vs. reported outcome

On 11 Apr 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 2 May 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT04609878
Acronym
KALOS
Drug Name
BREZTRI (PT010)
Drug MoA
triple-combination inhaler therapy of budesonide; glycopyrronium; and formoterol fumarate
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Inadequately Controlled Severe Asthma
Human Patients
2274
Sponsor
AstraZeneca
Phase
Phase 3

Prediction of , index 1962

Prospective Prediction
Prediction Index
1962
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in annualized rate of severe asthma exacerbation moderately superior to PT009/Symbicort; slightly superior to dupilumab; and non-superior-non-inferior to tezepelumab)
Technical Prediction
SUCCESS (statistically significant clinical benefit in FEV1 moderately superior to PT009/Symbicort)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
21 days in advance
Readout Data Interpretation
BREZTRI achieved statistically significant improvement in annualized rate of severe asthma exacerbation; superior to the ICS/LABA SoC treatment
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants With Inadequately Controlled Asthma
Phase
Phase 3
Status
Completed
Enrollment
2274
Lead sponsor
AstraZeneca
Conditions
Asthma
Interventions
DRUG: BGF MDI 320/28.8/9.6 μg; DRUG: BGF MDI 320/14.4/9.6 μg; DRUG: BFF MDI 320/9.6 μg; DRUG: BFF pMDI 320/9 μg
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2020-12-15
Primary completion
2025-03-21
Completion
2025-03-21
Results first posted
2026-06-30
Primary outcomes
  • Change From Baseline in FEV1 AUC0-3 (L) at Week 24 (Week 24)
  • Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations (Up to 52 weeks)

NCT04609878 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials