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Evaluating PT027 and PT007 for Asthma in Adolescents

This study is looking at two inhalers, budesonide/albuterol metered-dose inhaler (BDA MDI) and albuterol sulfate metered-dose inhaler (AS MDI), to see how well they prevent severe asthma attacks in adolescents. You might be able to join if you are 12 to less than 18 years old, have had asthma for at least a year, and have experienced a severe asthma attack in the past year. You also need to be on a stable asthma maintenance therapy. The main goal is to see if one inhaler is better at reducing the number of severe asthma attacks over 52 weeks. The study plans to enroll 440 participants, but its current status is unclear.

Study design
This is a randomized, double-blind study, meaning participants are assigned to one of two treatment groups by chance, and neither you nor your doctor will know which inhaler you are receiving. It involves 440 participants.
What's involved
You would participate in a screening period (7 to 28 days), a treatment period of 52 weeks, and a safety follow-up period of 7 to 14 days after treatment ends. There is also a single visit for a pharmacokinetic sub-study after the main study's follow-up.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for 7 to 14 days after the 52-week treatment period ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06307665

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

Recruiting
PHASE3Ages 12–17InterventionalTreatment
AstraZeneca
~440 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:BDA MDIAS MDI

At a glance

Recruiting sites
109 of 150 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Annualized rate of severe asthma exacerbations (AAER)
Measured over From Randomization (Day 1) to Week 52 (EOT)

Conditions

Asthma

Explore related trials

Asthma

Where it's being run

150 sites across 39 states
China22
Texas18
California14
New York13
Florida10
South Africa8
Ohio6
Mexico5

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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.

What this trial measures

  • Annualized rate of severe asthma exacerbations (AAER)From Randomization (Day 1) to Week 52 (EOT)

    The effect of BDA MDI compared with AS MDI, both administered as needed, on the AAER in participants with asthma will be evaluated.