Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06307665

PHASE3

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

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-blind, Multicenter, Parallel-group, Phase IIIb 52 Week Study Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered as Needed in Participants 12 to < 18 Years of Age With Asthma (ACADIA)

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

440

Start Date

2024-05-20

Completion Date

2027-10-13

Last Updated

2026-10-13

Healthy Volunteers

Conditions

Asthma

Interventions

COMBINATION_PRODUCT

BDA MDI

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

COMBINATION_PRODUCT

AS MDI

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

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 (155)

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

And 55 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (155)