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

NCT06307665

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Asthma

Interventions: BDA MDI, AS MDI

Countries: United States, China, Mexico, South Africa

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 overview

Sex: ALL

Age: 12 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (144)

Anchorage, Alaska, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Huntington Beach, California, United States
Huntington Beach, California, United States
Long Beach, California, United States
Long Beach, California, United States
Madera, California, United States
Mission Viejo, California, United States
Moreno Valley, California, United States
Orange, California, United States
Redondo Beach, California, United States
Riverside, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
Westminster, California, United States
Denver, Colorado, United States
Wilmington, Delaware, United States
Destin, Florida, United States
Jacksonville, Florida, United States
Kendall, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Fayetteville, Georgia, United States
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