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

Study identifier:D6934C00001

ClinicalTrials.gov identifier:NCT06307665

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

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)

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

Study drug

BDA MDI, AS MDI

Sex

All

Estimated Enrollment

440

Study type

Interventional

Age

12 Years - 17 Years

Date

Study Start Date: 20 May 2024

Estimated Primary Completion Date: 13 Oct 2027

Estimated Study Completion Date: 13 Oct 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion 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
a) Low-to-high-dose Inhaled corticosteroid(s) (ICS)
b) 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.

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Arms	Assigned Interventions
Experimental: 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.	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. Other Name: PT027
Active Comparator: Albuterol sulfate metered-dose inhaler (AS MDI) Participants will receive AS MDI 180 μg (given as 2 puffs of 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. Other Name: PT007

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]