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
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
Change History
17 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: PHASE3 → None
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Mar 2026 — May 2026 [monthly]
Recruiting PHASE3
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE3
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Dec 2025 — Feb 2026 [monthly]
Recruiting PHASE3
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Sep 2025 — Dec 2025 [monthly]
Recruiting PHASE3
▶ Show 12 earlier versions
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Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE3
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Jul 2025 — Aug 2025 [monthly]
Recruiting PHASE3
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Jun 2025 — Jul 2025 [monthly]
Recruiting PHASE3
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Jan 2025 — Jun 2025 [monthly]
Recruiting PHASE3
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Dec 2024 — Jan 2025 [monthly]
Recruiting PHASE3
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Oct 2024 — Dec 2024 [monthly]
Recruiting PHASE3
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Sep 2024 — Oct 2024 [monthly]
Recruiting PHASE3
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Aug 2024 — Sep 2024 [monthly]
Recruiting PHASE3
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Jul 2024 — Aug 2024 [monthly]
Recruiting PHASE3
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Jun 2024 — Jul 2024 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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May 2024 — Jun 2024 [monthly]
Not Yet Recruiting PHASE3
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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
- AstraZeneca
- Parexel
For direct contact, visit the study record on ClinicalTrials.gov .