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Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma

← catalyst calendar

NCT06307665 · readout in 420 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Parexel.

Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
440estimated
Sites
150
Countries
China, Mexico, South Africa +1

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
DateFiledBasisWhat it is
Start2024-05-20actualWhen the study began enrolling
Primary completion2027-10-13estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2027-10-13estimatedThe whole study's end, after follow-up
First posted2024-03-13actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-13actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Asthma

Interventions

  • Combination product: BDA MDI — also filed as PT027
  • Combination product: AS MDI — also filed as PT007

Primary outcome

what the primary-completion date above is the date OF
Annualized rate of severe asthma exacerbations (AAER)
measured From Randomization (Day 1) to Week 52 (EOT)

Publications

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.

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