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Comparing two inhalers for asthma in adolescents

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)

Phase 3 Interventional AstraZeneca · NCT06307665

This study is testing whether a new combination inhaler can help teenagers with asthma have fewer severe attacks compared to a standard inhaler.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment440 (estimated)
Ages12 Years to 17 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations135 sites (Anchorage, Alaska and 134 other locations)
Trial IDNCT06307665 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of a budesonide/albuterol metered-dose inhaler (BDA MDI) compared to an albuterol sulfate metered-dose inhaler (AS MDI) in adolescents aged 12 to under 18 years with asthma. The study is a randomized, double-blind, multicenter, parallel-group Phase IIIb trial that will last for 52 weeks, including a screening period and a safety follow-up. Participants will be randomly assigned to receive either BDA MDI or AS MDI in addition to their usual asthma maintenance therapy, with the primary focus on the annualized rate of severe asthma exacerbations.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12 to under 18 years with a confirmed diagnosis of asthma and a history of at least one severe exacerbation in the past year.

Not a fit: Patients who do not have a documented history of severe asthma exacerbations or are not currently receiving maintenance therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for adolescents with asthma, potentially reducing the frequency of severe exacerbations.

How similar studies have performed: Other studies have shown success with similar approaches in evaluating inhaled therapies for asthma, indicating that this methodology is well-established.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Confirmed clinical diagnosis of asthma at least 12 months.
* Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month

  1. Low-to-high-dose Inhaled corticosteroid(s) (ICS)
  2. Low-to-high-dose ICS or ICS/long-acting β2-agonist (LABA) with or without one additional maintenance therapy from the following: leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), or theophylline
* Receiving inhaled short-acting β2-agonist (SABA) as needed.
* A documented history of at least one severe asthma exacerbation within 12 months.
* Use of Sponsor-provided albuterol sulfate inhalation aerosol medication.
* Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited.
* Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator.
* Participants must adhere to protocol specific contraception methods.
* Negative urine pregnancy test for participants of childbearing potential.
* Have a BMI \< 40 kg/ m\^2.
* Capable of giving assent (signing the assent form) to participate in the study which includes compliance with the requirements and restrictions. The caregiver of the patient must be capable of giving written informed consent for the patient's participation in the study. Consent and assent forms must be completed prior to any study-specific procedures.

Exclusion Criteria:

* Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
* Experienced \> 3 severe asthma exacerbations within 12 months before screening.
* Completed treatment for lower respiratory infection and severe asthma exacerbation with SCS within 4 weeks of screening.
* Upper respiratory infection involving antibiotic treatment not resolved.
* Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana).
* Other significant lung disease, including regular or occasional use of oxygen.
* Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, or gastrointestinal disorders.
* Cancer not in complete remission for at least 5 years.
* History or hospitalization for psychiatric disorder or attempted suicide within one year.
* Significant abuse of alcohol or drugs, in the opinion of the investigator.
* Oral corticosteroid(s) (OCS)/SCS use (any dose and any indication) within 4 weeks before Visit 1 or chronic use of OCS/SCS (≥ 3 weeks use in 3 months prior to Visit 1).
* Use of any oral SABAs within one month.
* Having a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients.

Where this trial is running

Anchorage, Alaska and 134 other locations

+85 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AsthmaFast-acting β2-agonistMetered-Dose InhalerBronchodilatoryInhaled corticosteroidsAnti-inflammatoryRescue Therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.