deltatrials
Recruiting INTERVENTIONAL NCT06307665

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

A Randomized, Double-blind, Multicenter, Parallel-group, Phase IIIb 52 Week Study Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered as Needed in Participants 12 to < 18 Years of Age With Asthma (ACADIA)

Sponsor: AstraZeneca

Conditions Asthma
Interventions AS MDI BDA MDI
Updated 17 times since 2024 Last updated: Apr 30, 2026 Started: May 20, 2024 Primary completion: Oct 13, 2027 Completion: Oct 13, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Asthma and is currently actively recruiting participants. AstraZeneca leads this study, which shows 17 recorded versions since 2024 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks. The study will consist of 3 periods: 1. Screening period (7 to 28 days) 2. Treatment period of 52 weeks 3. Safety follow-up period (7 to 14 days after the end of treatment \[EOT\] visit) Participants who meet the eligibility criteria will be randomly assigned to BDA MDI 160/180 micrograms (μg) or AS MDI 180 μg treatment groups in a 1:1 ratio on top of their own usual maintenance therapy during treatment period. This study will also include a pharmacokinetic (PK) sub-study with single visit scheduled after the safety follow-up visit in the main study. During PK sub-study, single dose of open-label BDA MDI 160/180 μg will be administered.

This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks.

The study will consist of 3 periods:

1. Screening period (7 to 28 days) 2. Treatment period of 52 weeks 3. Safety follow-up period (7 to 14 days after the end of treatment \[EOT\] visit)

Participants who meet the eligibility criteria will be randomly assigned to BDA MDI 160/180 micrograms (μg) or AS MDI 180 μg treatment groups in a 1:1 ratio on top of their own usual maintenance therapy during treatment period.

This study will also include a pharmacokinetic (PK) sub-study with single visit scheduled after the safety follow-up visit in the main study. During PK sub-study, single dose of open-label BDA MDI 160/180 μg will be administered.

Status Flow

~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Dec 2024 · 2 months · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Jun 2025 · 5 months · monthly snapshotRecruiting~Jun 2025 – ~Jul 2025 · 30 days · monthly snapshot~Jul 2025 – ~Aug 2025 · 31 days · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshotRecruiting~Dec 2025 – ~Feb 2026 · 2 months · monthly snapshot~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshot~Mar 2026 – ~May 2026 · 2 months · monthly snapshotRecruitingMay 4, 2026 – present · 28 days · daily API

Change History

17 versions recorded
  1. May 4, 2026 — Present [daily]

    Recruiting

    Phase: PHASE3None

  2. Mar 2026 — May 2026 [monthly]

    Recruiting PHASE3

  3. Feb 2026 — Mar 2026 [monthly]

    Recruiting PHASE3

  4. Dec 2025 — Feb 2026 [monthly]

    Recruiting PHASE3

  5. Sep 2025 — Dec 2025 [monthly]

    Recruiting PHASE3

Show 12 earlier versions
  1. Aug 2025 — Sep 2025 [monthly]

    Recruiting PHASE3

  2. Jul 2025 — Aug 2025 [monthly]

    Recruiting PHASE3

  3. Jun 2025 — Jul 2025 [monthly]

    Recruiting PHASE3

  4. Jan 2025 — Jun 2025 [monthly]

    Recruiting PHASE3

  5. Dec 2024 — Jan 2025 [monthly]

    Recruiting PHASE3

  6. Oct 2024 — Dec 2024 [monthly]

    Recruiting PHASE3

  7. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE3

  8. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

  9. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE3

  10. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  11. May 2024 — Jun 2024 [monthly]

    Not Yet Recruiting PHASE3

  12. Apr 2024 — May 2024 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.

Contact Information

Sponsor contact:
  • AstraZeneca
  • Parexel
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .