Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)
Phase 3
Completed
NCT04609904
| Condition | Asthma |
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| Phase | Phase 3 |
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| Sponsor | AstraZeneca |
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| Status | Completed |
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| Enrollment | 2,187 participants |
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| Interventions | BGF MDI 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg, BFF MDI 320/9.6 μg, BFF pMDI 320/9 μg |
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| Start date | Mar 1, 2021 |
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| Completion date | Mar 20, 2025 |
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| Results posted | Jul 2, 2026 |
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Summary
This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.
Change From Baseline in FEV1 AUC0-3 (L) at Week 24
Week 24 · Liters
| BGF MDI 320/14.4/9.6 μg BID | 0.374 ± 0.019 Liters |
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| BGF MDI 320/28.8/9.6 μg BID | 0.354 ± 0.015 Liters |
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| BFF MDI 320/9.6 μg BID | 0.219 ± 0.015 Liters |
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| Symbicort® 320/9 μg BID | 0.239 ± 0.015 Liters |
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| p-value | <0.001 |
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| LS Mean Difference | 0.155 (95% CI 0.109–0.201) |
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Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations
Up to 52 Weeks · Exacerbations/Subject Years
| BGF MDI 320/14.4/9.6 μg BID | 0.533 Exacerbations/Subject Years |
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| BGF MDI 320/28.8/9.6 μg BID | 0.541 Exacerbations/Subject Years |
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| BFF MDI 320/9.6 μg BID | 0.604 Exacerbations/Subject Years |
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| Symbicort® 320/9 μg BID | 0.662 Exacerbations/Subject Years |
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| p-value | 0.120 |
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| Rate ratio | 0.882 (95% CI 0.754–1.033) |
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Open in BENITIONS
View on ClinicalTrials.gov
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