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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT06307665

Registry updated: 2026-10-13
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Description

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.

Interventions

  • BDA MDI (Combination product)
    Participants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed.
  • AS MDI (Combination product)
    Participants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed.

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.

Conditions

Asthma

Locations

  • Research Site — Anchorage, Alaska, United States
  • Research Site — Gilbert, Arizona, United States
  • Research Site — Phoenix, Arizona, United States
  • Research Site — Little Rock, Arkansas, United States
  • Research Site — Huntington Beach, California, United States
  • Research Site — Huntington Beach, California, United States
  • Research Site — Long Beach, California, United States
  • Research Site — Long Beach, California, United States
  • Research Site — Madera, California, United States
  • Research Site — Mission Viejo, California, United States
  • Research Site — Moreno Valley, California, United States
  • Research Site — Orange, California, United States
  • Research Site — Redondo Beach, California, United States
  • Research Site — Riverside, California, United States
  • Research Site — San Diego, California, United States
  • Research Site — San Diego, California, United States
  • Research Site — San Francisco, California, United States
  • Research Site — Westminster, California, United States
  • Research Site — Denver, Colorado, United States
  • Research Site — Wilmington, Delaware, United States
  • Research Site — Destin, Florida, United States
  • Research Site — Jacksonville, Florida, United States
  • Research Site — Kendall, Florida, United States
  • Research Site — Largo, Florida, United States
  • Research Site — Miami, Florida, United States
  • Research Site — Miami, Florida, United States
  • Research Site — Miami, Florida, United States
  • Research Site — Miami, Florida, United States
  • Research Site — Miami, Florida, United States
  • Research Site — Orlando, Florida, United States
  • Research Site — Pembroke Pines, Florida, United States
  • Research Site — Tampa, Florida, United States
  • Research Site — Atlanta, Georgia, United States
  • Research Site — Columbus, Georgia, United States
  • Research Site — Fayetteville, Georgia, United States
  • Research Site — Snellville, Georgia, United States
  • Research Site — Meridian, Idaho, United States
  • Research Site — Normal, Illinois, United States
  • Research Site — River Forest, Illinois, United States
  • Research Site — Indianapolis, Indiana, United States
  • Research Site — Kansas City, Kansas, United States
  • Research Site — Louisville, Kentucky, United States
  • Research Site — Louisville, Kentucky, United States
  • Research Site — Lafayette, Louisiana, United States
  • Research Site — New Orleans, Louisiana, United States
  • Research Site — New Orleans, Louisiana, United States
  • Research Site — Ellicott City, Maryland, United States
  • Research Site — Lanham, Maryland, United States
  • Research Site — Silver Spring, Maryland, United States
  • Research Site — White Marsh, Maryland, United States
  • Research Site — Boston, Massachusetts, United States
  • Research Site — Detroit, Michigan, United States
  • Research Site — Mankato, Minnesota, United States
  • Research Site — Kansas City, Missouri, United States
  • Research Site — Kansas City, Missouri, United States
  • Research Site — St Louis, Missouri, United States
  • Research Site — Missoula, Montana, United States
  • Research Site — Lincoln, Nebraska, United States
  • Research Site — Lincoln, Nebraska, United States
  • Research Site — Omaha, Nebraska, United States
  • Research Site — Newark, New Jersey, United States
  • Research Site — Northfield, New Jersey, United States
  • Research Site — Ocean City, New Jersey, United States
  • Research Site — Paramus, New Jersey, United States
  • Research Site — Albuquerque, New Mexico, United States
  • Research Site — Albany, New York, United States
  • Research Site — Cortland, New York, United States
  • Research Site — Hawthorne, New York, United States
  • Research Site — Hollis, New York, United States
  • Research Site — New York, New York, United States
  • Research Site — New York, New York, United States
  • Research Site — New York, New York, United States
  • Research Site — Rochester, New York, United States
  • Research Site — The Bronx, New York, United States
  • Research Site — The Bronx, New York, United States
  • Research Site — Vestal, New York, United States
  • Research Site — Vestal, New York, United States
  • Research Site — Watertown, New York, United States
  • Research Site — Charlotte, North Carolina, United States
  • Research Site — Durham, North Carolina, United States
  • Research Site — Cincinnati, Ohio, United States
  • Research Site — Columbus, Ohio, United States
  • Research Site — Columbus, Ohio, United States
  • Research Site — Dayton, Ohio, United States
  • Research Site — Findlay, Ohio, United States
  • Research Site — Toledo, Ohio, United States
  • Research Site — Oklahoma City, Oklahoma, United States
  • Research Site — Oklahoma City, Oklahoma, United States
  • Research Site — Oklahoma City, Oklahoma, United States
  • Research Site — Yukon, Oklahoma, United States
  • Research Site — Pittsburgh, Pennsylvania, United States
  • Research Site — Charleston, South Carolina, United States
  • Research Site — Rock Hill, South Carolina, United States
  • Research Site — Sioux Falls, South Dakota, United States
  • Research Site — Nashville, Tennessee, United States
  • Research Site — Austin, Texas, United States
  • Research Site — Baytown, Texas, United States
  • Research Site — Beaumont, Texas, United States
  • Research Site — Beaumont, Texas, United States
  • Research Site — Bellaire, Texas, United States
  • Research Site — Corpus Christi, Texas, United States
  • Research Site — Corsicana, Texas, United States
  • Research Site — Dallas, Texas, United States
  • Research Site — Dallas, Texas, United States
  • Research Site — El Paso, Texas, United States
  • Research Site — Frisco, Texas, United States
  • Research Site — Houston, Texas, United States
  • Research Site — Houston, Texas, United States
  • Research Site — Houston, Texas, United States
  • Research Site — Kerrville, Texas, United States
  • Research Site — McKinney, Texas, United States
  • Research Site — San Antonio, Texas, United States
  • Research Site — San Antonio, Texas, United States
  • Research Site — San Antonio, Texas, United States
  • Research Site — Tyler, Texas, United States
  • Research Site — West Jordan, Utah, United States
  • Research Site — Burlington, Vermont, United States
  • Research Site — Burke, Virginia, United States
  • Research Site — Bellingham, Washington, United States
  • Research Site — Vancouver, Washington, United States
  • Research Site — Beijing, China
  • Research Site — Beijing, China
  • Research Site — Bengbu, China
  • Research Site — Chengdu, China
  • Research Site — Chongqing, China
  • Research Site — Hohhot, China
  • Research Site — Mianyang, China
  • Research Site — Shanghai, China
  • Research Site — Shanghai, China
  • Research Site — Shanghai, China
  • Research Site — Shantou, China
  • Research Site — Shenyang, China
  • Research Site — Shenzhen, China
  • Research Site — Suzhou, China
  • Research Site — Taizhou, China
  • Research Site — Tianjin, China
  • Research Site — Tianjin, China
  • Research Site — Tianjin, China
  • Research Site — Wuhan, China
  • Research Site — Yanji, China
  • Research Site — Yantai, China
  • Research Site — Zhongshan, China
  • Research Site — Chihuahua City, Mexico
  • Research Site — Chihuahua City, Mexico
  • Research Site — Guadalajara, Mexico
  • Research Site — Guadalajara, Mexico
  • Research Site — Monterrey, Mexico
  • Research Site — Durban, South Africa
  • Research Site — Durban, South Africa
  • Research Site — Durban, South Africa
  • Research Site — Krugersdorp, South Africa
  • Research Site — Middelburg, South Africa
  • Research Site — Panorama, South Africa
  • Research Site — Somerset West, South Africa
  • Research Site — Welkom, South Africa
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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