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NCT04609878 · ClinicalTrials.gov registry record · Phase 3
Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,274
- Enrollment target
NCT04609878: Completed Phase 3 study, sponsored by AstraZeneca.
NCT04609878 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 2,274 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (195% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04609878, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,274 participants
- Enrollment target
Study 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
Primary Outcome
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24. Treatment policy was implemented to handle all intercurrent events (ICEs) with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Interventions
- DRUG BGF MDI 320/14.4/9.6 μg
- DRUG BFF MDI 320/9.6 μg
- DRUG BGF MDI 320/28.8/9.6 μg
- DRUG BFF pMDI 320/9 μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,274 participants |
| Start Date | 2020-12-15 |
| Est. Completion | 2025-03-21 |
| Phase | Phase 3 |
What the finished NCT04609878 record still lists
NCT04609878 is an interventional study that assigns participants to a tested intervention. Its 2,274 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (195% higher).
The record links to 0 conditions, and to 4 interventions - of which BGF MDI 320/14.4/9.6 μg is the first listed.
NCT04609878 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04609878 about?
NCT04609878 is a clinical study titled "Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)". 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
What is the current status of trial NCT04609878?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,274 participants. The study started on 2020-12-15. Estimated completion is 2025-03-21.
What interventions are being tested in trial NCT04609878?
The interventions under investigation include: BGF MDI 320/14.4/9.6 μg (DRUG), BFF MDI 320/9.6 μg (DRUG), BGF MDI 320/28.8/9.6 μg (DRUG), BFF pMDI 320/9 μg (DRUG).
Who is sponsoring clinical trial NCT04609878?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04609878's enrollment target sits among peer trials
2,274 94th of 2000 higher than 1,907 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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