Recruiting

Phase 3

Asthma Research Study for Ages 12–17Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma

Sponsor:

AstraZeneca

Code:

NCT06307665

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

BDA MDI

AS MDI

Study Details

Brief 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.

Conditions

Asthma

Study ID

NCT06307665

Start date

May 20, 2024

Status verified date

Aug, 2026

Completion date

Oct 13, 2027

Anticipated

Primary completion date

Oct 13, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Budesonide/albuterol metered -dose inhaler (BDA MDI)

Participants will receive BDA MDI 160/180 μg (given as 2 puffs of 80/90 μg) as needed.

active comparator: Albuterol sulfate metered-dose inhaler (AS MDI)

Participants will receive AS MDI 180 μg (given as 2 puffs of 90 μg) as needed.

Interventions

BDA MDI

Participants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed.

AS MDI

Participants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed.

Primary outcome measure

Annualized rate of severe asthma exacerbations (AAER) [ Time Frame: From Randomization (Day 1) to Week 52 (EOT) ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

Locations

Research Site

Recruiting

Anchorage, Alaska, United States, 99508

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Gilbert, Arizona, United States, 85234

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Phoenix, Arizona, United States, 85016

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Long Beach, California, United States, 90806

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Long Beach, California, United States, 90815

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Mission Viejo, California, United States, 92691

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Moreno Valley, California, United States, 92553

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Orange, California, United States, 92868

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Riverside, California, United States, 92506

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San Diego, California, United States, 92123

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Westminster, California, United States, 92683

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Denver, Colorado, United States, 80206

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Wilmington, Delaware, United States, 19803

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Destin, Florida, United States, 32541

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Jacksonville, Florida, United States, 32207

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Miami, Florida, United States, 33145

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Miami, Florida, United States, 33185

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Atlanta, Georgia, United States, 30329

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Columbus, Georgia, United States, 31904

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Fayetteville, Georgia, United States, 30214

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Snellville, Georgia, United States, 30078

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Normal, Illinois, United States, 61761

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Indianapolis, Indiana, United States, 46202

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Kansas City, Kansas, United States, 66160

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Louisville, Kentucky, United States, 40202

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Lafayette, Louisiana, United States, 70508

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New Orleans, Louisiana, United States, 70121

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New Orleans, Louisiana, United States, 70125

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Ellicott City, Maryland, United States, 21043

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Silver Spring, Maryland, United States, 20902

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White Marsh, Maryland, United States, 21162

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Detroit, Michigan, United States, 48201

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Kansas City, Missouri, United States, 64118

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Missoula, Montana, United States, 59804

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Lincoln, Nebraska, United States, 68510

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Lincoln, Nebraska, United States, 68516

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Omaha, Nebraska, United States, 68114

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Newark, New Jersey, United States, 07103

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Northfield, New Jersey, United States, 08225

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Ocean City, New Jersey, United States, 07712

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Paramus, New Jersey, United States, 07652

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Albuquerque, New Mexico, United States, 87106

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Albany, New York, United States, 12208

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Cortland, New York, United States, 13045

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Hawthorne, New York, United States, 10532

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New York, New York, United States, 10032

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The Bronx, New York, United States, 10459

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The Bronx, New York, United States, 10461

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Vestal, New York, United States, 13850

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Watertown, New York, United States, 13601

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Columbus, Ohio, United States, 43228

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Dayton, Ohio, United States, 45424

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Findlay, Ohio, United States, 45840

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Toledo, Ohio, United States, 43617

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Oklahoma City, Oklahoma, United States, 73104

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Oklahoma City, Oklahoma, United States, 73120

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Yukon, Oklahoma, United States, 73099

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Pittsburgh, Pennsylvania, United States, 15241

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Charleston, South Carolina, United States, 29425

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Sioux Falls, South Dakota, United States, 57105

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Nashville, Tennessee, United States, 37232

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Austin, Texas, United States, 78759

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Baytown, Texas, United States, 77521

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Beaumont, Texas, United States, 77701

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Bellaire, Texas, United States, 77401

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Corsicana, Texas, United States, 75110

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Dallas, Texas, United States, 75231

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Houston, Texas, United States, 77065

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Houston, Texas, United States, 77099

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McKinney, Texas, United States, 75069

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San Antonio, Texas, United States, 78215

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San Antonio, Texas, United States, 78229

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West Jordan, Utah, United States, 84088

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Burlington, Vermont, United States, 05405

Research Site

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Vancouver, Washington, United States, 98664

More Information

Sponsor

AstraZeneca

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

Fast-acting β2-agonist
Metered-Dose Inhaler (MDI)
Bronchodilatory
Inhaled corticosteroids
Anti-inflammatory
Rescue Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-13.