Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)
Phase 3
Completed
NCT04609878
| Condition | Asthma |
|---|
| Phase | Phase 3 |
|---|
| Sponsor | AstraZeneca |
|---|
| Status | Completed |
|---|
| Enrollment | 2,274 participants |
|---|
| 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 |
|---|
| Start date | Dec 15, 2020 |
|---|
| Completion date | Mar 21, 2025 |
|---|
| Results posted | Jun 30, 2026 |
|---|
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 | 0.281 ± 0.018 Liters |
|---|
| BGF MDI 320/28.8/9.6 μg BID | 0.316 ± 0.014 Liters |
|---|
| BFF MDI 320/9.6 μg BID | 0.249 ± 0.014 Liters |
|---|
| Symbicort® pMDI 320/9 μg BID | 0.220 ± 0.014 Liters |
|---|
| p-value | 0.168 |
|---|
| LS Mean Difference | 0.032 (95% CI -0.013–0.077) |
|---|
Pooled (KALOS/LOGOS): 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 |
|---|
| BGF MDI 320/28.8/9.6 μg BID | 0.541 Exacerbations/Subject Years |
|---|
| BFF MDI 320/9.6 μg BID | 0.604 Exacerbations/Subject Years |
|---|
| Symbicort® pMDI 320/9 μg BID | 0.662 Exacerbations/Subject Years |
|---|
| p-value | 0.120 |
|---|
| Rate ratio | 0.882 (95% CI 0.754–1.033) |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
Other trials for this condition
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.