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NCT06307665PHASE3Recruiting

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

AstraZeneca

Start Date

5/20/2024

Completion Date

10/13/2027

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.

Detailed Description

This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks. The study will consist of 3 periods: 1. Screening period (7 to 28 days) 2. Treatment period of 52 weeks 3. Safety follow-up period (7 to 14 days after the end of treatment \[EOT\] visit) Participants who meet the eligibility criteria will be randomly assigned to BDA MDI 160/180 micrograms (μg) or AS MDI 180 μg treatment groups in a 1:1 ratio on top of their own usual maintenance therapy during treatment period. This study will also include a pharmacokinetic (PK) sub-study with single visit scheduled after the safety follow-up visit in the main study. During PK sub-study, single dose of open-label BDA MDI 160/180 μg will be administered.

Eligibility Criteria

Age Range: 12 years to 17 years

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.

Interventions

COMBINATION_PRODUCT

BDA MDI

COMBINATION_PRODUCT

AS MDI

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Conditions

Asthma

Locations

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Anchorage, Alaska 99508

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Gilbert, Arizona 85234

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Phoenix, Arizona 85016

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Little Rock, Arkansas 72202

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Huntington Beach, California 92647

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Huntington Beach, California 92648

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Long Beach, California 90806

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Long Beach, California 90815

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Madera, California 93636

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Mission Viejo, California 92691

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Moreno Valley, California 92553

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Orange, California 92868

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Redondo Beach, California 90277

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Riverside, California 92506

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San Diego, California 92123

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San Diego, California 92123

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San Francisco, California 94143

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Westminster, California 92683

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Denver, Colorado 80206

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Wilmington, Delaware 19803

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Destin, Florida 32541

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Jacksonville, Florida 32207

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Kendall, Florida 33176

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Largo, Florida 33777

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Miami, Florida 33145

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Pembroke Pines, Florida 33026

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Tampa, Florida 33613

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Atlanta, Georgia 30329

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Columbus, Georgia 31904

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Fayetteville, Georgia 30214

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Snellville, Georgia 30078

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Meridian, Idaho 83646

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Normal, Illinois 61761

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River Forest, Illinois 60305

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Indianapolis, Indiana 46202

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Kansas City, Kansas 66160

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Louisville, Kentucky 40202

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Louisville, Kentucky 40217

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Lafayette, Louisiana 70508

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New Orleans, Louisiana 70121

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New Orleans, Louisiana 70125

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Ellicott City, Maryland 21043

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Lanham, Maryland 20706

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Silver Spring, Maryland 20902

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White Marsh, Maryland 21162

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Boston, Massachusetts 02114

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Detroit, Michigan 48201

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Mankato, Minnesota 56001

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Kansas City, Missouri 64108

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Kansas City, Missouri 64118

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Missoula, Montana 59804

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Lincoln, Nebraska 68510

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Lincoln, Nebraska 68516

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Omaha, Nebraska 68114

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Newark, New Jersey 07103

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Northfield, New Jersey 08225

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Ocean City, New Jersey 07712

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Paramus, New Jersey 07652

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Albuquerque, New Mexico 87106

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Albany, New York 12208

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Cortland, New York 13045

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Hawthorne, New York 10532

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Hollis, New York 11423

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New York, New York 10019

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New York, New York 10032

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Rochester, New York 14607

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The Bronx, New York 10459

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The Bronx, New York 10461

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Vestal, New York 13850

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Vestal, New York 13850

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Watertown, New York 13601

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Charlotte, North Carolina 28277

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Cincinnati, Ohio 45229

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Columbus, Ohio 43205

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Columbus, Ohio 43228

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Dayton, Ohio 45424

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Findlay, Ohio 45840

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Toledo, Ohio 43617

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Oklahoma City, Oklahoma 73104

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Oklahoma City, Oklahoma 73120

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Yukon, Oklahoma 73099

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Pittsburgh, Pennsylvania 15241

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Charleston, South Carolina 29425

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Rock Hill, South Carolina 29730

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Sioux Falls, South Dakota 57105

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Nashville, Tennessee 37232

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Austin, Texas 78759

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Baytown, Texas 77521

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Beaumont, Texas 77701

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Beaumont, Texas 77702

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Bellaire, Texas 77401

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Corsicana, Texas 75110

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Dallas, Texas 75231

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El Paso, Texas 79912

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Frisco, Texas 75034

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Houston, Texas 77030

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Houston, Texas 77065

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Houston, Texas 77099

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Kerrville, Texas 78028

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McKinney, Texas 75069

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San Antonio, Texas 78215

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San Antonio, Texas 78229

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San Antonio, Texas 78249

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Tyler, Texas 75708

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West Jordan, Utah 84088

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Burlington, Vermont 05405

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Burke, Virginia 22015

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Bellingham, Washington 98225

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Vancouver, Washington 98664

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Beijing, 100050

China

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Beijing, 100191

China

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Bengbu, 233004

China

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Chengdu, 610066

China

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Chongqing, 401122

China

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Hohhot, 10050

China

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Mianyang, 621000

China

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Shanghai, 200062

China

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Shanghai, 200433

China

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Shanghai,

China

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Shantou, 515041

China

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Shenyang, 110004

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Shenzhen, 518026

China

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Suzhou, 215002

China

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Taizhou, 318000

China

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Tianjin, 300050

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Tianjin, 300134

China

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Tianjin, 300211

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Wuhan, 430000

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Yanji, 133000

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Yantai, 264000

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Zhongshan, 528400

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Chihuahua City, 31000

Mexico

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Chihuahua City, 31238

Mexico

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Guadalajara, 44100

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Guadalajara, 44500

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Monterrey, 64465

Mexico

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Durban, 3630

South Africa

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Durban, 4001

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Durban, 4092

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Krugersdorp, 1739

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Middelburg, 1055

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Panorama, 7500

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Somerset West, 7130

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Welkom, 9460

South Africa