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Clinical Trials in the USA / NCT06307665
Recruiting Phase 3

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

NCT06307665 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2024-05-20
Last updated
2026-08-13

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

BDA MDIAS MDI

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.

Study 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (150)

FacilityCityRegionStatus
Research Site Anchorage Alaska Recruiting
Research Site Gilbert Arizona Recruiting
Research Site Phoenix Arizona Recruiting
Research Site Little Rock Arkansas Completed
Research Site Huntington Beach California Not Yet Recruiting
Research Site Huntington Beach California Not Yet Recruiting
Research Site Long Beach California Recruiting
Research Site Long Beach California Recruiting
Research Site Madera California Not Yet Recruiting
Research Site Mission Viejo California Recruiting
Research Site Moreno Valley California Recruiting
Research Site Orange California Recruiting
Research Site Redondo Beach California Not Yet Recruiting
Research Site Riverside California Recruiting
Research Site San Diego California Recruiting
Research Site San Diego California Not Yet Recruiting
Research Site San Francisco California Withdrawn
Research Site Westminster California Recruiting
Research Site Denver Colorado Recruiting
Research Site Wilmington Delaware Recruiting
Research Site Destin Florida Recruiting
Research Site Jacksonville Florida Recruiting
Research Site Kendall Florida Not Yet Recruiting
Research Site Largo Florida Completed
Research Site Miami Florida Not Yet Recruiting
Research Site Miami Florida Not Yet Recruiting
Research Site Miami Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Pembroke Pines Florida Not Yet Recruiting
Research Site Tampa Florida Withdrawn
Research Site Atlanta Georgia Recruiting
Research Site Columbus Georgia Recruiting
Research Site Fayetteville Georgia Recruiting
Research Site Snellville Georgia Recruiting
Research Site Meridian Idaho Withdrawn
Research Site Normal Illinois Recruiting
Research Site River Forest Illinois Withdrawn
Research Site Indianapolis Indiana Recruiting
Research Site Kansas City Kansas Recruiting
Research Site Louisville Kentucky Recruiting

+ 110 more sites — see the full list on the official registry below.

More AstraZeneca trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06307665 on ClinicalTrials.gov ↗ ← All trials in the USA