Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
2,274actual
Sites
360
Countries
Argentina, Belgium, Bulgaria +18
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-12-15 | actual | When the study began enrolling |
| Primary completion | 2025-03-21 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-03-21 | actual | The whole study's end, after follow-up |
| First posted | 2020-10-30 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-30 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Asthma
Interventions
- Drug: BGF MDI 320/28.8/9.6 μg — also filed as BGF
- Drug: BGF MDI 320/14.4/9.6 μg — also filed as BGF
- Drug: BFF MDI 320/9.6 μg — also filed as BFF
- Drug: BFF pMDI 320/9 μg — also filed as Symbicort®
Primary outcomes
what the primary-completion date above is the date OFChange From Baseline in FEV1 AUC0-3 (L) at Week 24
measured Week 24
Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations
measured Up to 52 weeks
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-11-19 · 20.4 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-03-24 · 4.3 MB · SAP_001.pdf
Publications
- PMID 41692019 — linked by the registry
- PMID 36472162 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · AZN's whole pipeline · Catalyst calendar · Every registered study · What changed