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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

NCT ID: NCT06307665

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2027-10-13

Brief Summary

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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.

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A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With Asthma

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Budesonide/albuterol metered -dose inhaler (BDA MDI)

Participants will receive BDA MDI 160/180 μg (given as 2 puffs of 80/90 μg) as needed.

Group Type EXPERIMENTAL

BDA MDI

Intervention Type COMBINATION_PRODUCT

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

Albuterol sulfate metered-dose inhaler (AS MDI)

Participants will receive AS MDI 180 μg (given as 2 puffs of 90 μg) as needed.

Group Type ACTIVE_COMPARATOR

AS MDI

Intervention Type COMBINATION_PRODUCT

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

Interventions

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BDA MDI

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

Intervention Type COMBINATION_PRODUCT

AS MDI

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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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PT027 PT007

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parexel

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Anchorage, Alaska, United States

Site Status RECRUITING

Research Site

Gilbert, Arizona, United States

Site Status RECRUITING

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Phoenix, Arizona, United States

Site Status NOT_YET_RECRUITING

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Little Rock, Arkansas, United States

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Long Beach, California, United States

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Long Beach, California, United States

Site Status NOT_YET_RECRUITING

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Madera, California, United States

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Mission Viejo, California, United States

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Moreno Valley, California, United States

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Orange, California, United States

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Riverside, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Westminster, California, United States

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Denver, Colorado, United States

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Wilmington, Delaware, United States

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Destin, Florida, United States

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Jacksonville, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Fayetteville, Georgia, United States

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Meridian, Idaho, United States

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Normal, Illinois, United States

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River Forest, Illinois, United States

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Indianapolis, Indiana, United States

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Kansas City, Kansas, United States

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Louisville, Kentucky, United States

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Lafayette, Louisiana, United States

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New Orleans, Louisiana, United States

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Ellicott City, Maryland, United States

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Silver Spring, Maryland, United States

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White Marsh, Maryland, United States

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Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

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Detroit, Michigan, United States

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Mankato, Minnesota, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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Missoula, Montana, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Newark, New Jersey, United States

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Northfield, New Jersey, United States

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Ocean City, New Jersey, United States

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Paramus, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Cortland, New York, United States

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Hawthorne, New York, United States

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Hollis, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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The Bronx, New York, United States

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Vestal, New York, United States

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Vestal, New York, United States

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Watertown, New York, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Findlay, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Yukon, Oklahoma, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Rock Hill, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Baytown, Texas, United States

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Beaumont, Texas, United States

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Bellaire, Texas, United States

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Corsicana, Texas, United States

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Dallas, Texas, United States

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Frisco, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Kerrville, Texas, United States

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McKinney, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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West Jordan, Utah, United States

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Burlington, Vermont, United States

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Burke, Virginia, United States

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Bellingham, Washington, United States

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Vancouver, Washington, United States

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Beijing, , China

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Beijing, , China

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Bengbu, , China

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Chengdu, , China

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Chongqing, , China

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Hohhot, , China

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Mianyang, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shenyang, , China

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Shenzhen, , China

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Suzhou, , China

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Taizhou, , China

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Tianjin, , China

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Tianjin, , China

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Wuhan, , China

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Yanji, , China

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Yantai, , China

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Zhongshan, , China

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Chihuahua City, , Mexico

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Chihuahua City, , Mexico

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Guadalajara, , Mexico

Site Status NOT_YET_RECRUITING

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Guadalajara, , Mexico

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Monterrey, , Mexico

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Durban, , South Africa

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Durban, , South Africa

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Durban, , South Africa

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Krugersdorp, , South Africa

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Middelburg, , South Africa

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Panorama, , South Africa

Site Status RECRUITING

Research Site

Somerset West, , South Africa

Site Status NOT_YET_RECRUITING

Research Site

Welkom, , South Africa

Site Status RECRUITING

Countries

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United States China Mexico South Africa

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

[email protected]
1-877-240-9479

Other Identifiers

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D6934C00001

Identifier Type: -

Identifier Source: org_study_id

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