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

Launched by ASTRAZENECA · Mar 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective and safe a new inhaler called PT027 is compared to a standard inhaler called PT007 for treating asthma in adolescents aged 12 to 17. The goal is to see which inhaler better prevents severe asthma attacks in participants who have had at least one serious asthma episode in the past year. The trial is currently recruiting participants who have a confirmed diagnosis of asthma and are already using certain asthma medications regularly.

To be eligible for the study, participants should have been diagnosed with asthma for at least a year and have experienced at least one severe asthma attack in the last 12 months. They must also be using specific asthma treatments consistently. Participants will be expected to use the inhalers as needed and will need to show that they can use them correctly. The study will help researchers understand how well these inhalers work and ensure they are safe for young people with asthma.

Gender

ALL

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.