Norton Children’s Pulmonology, affiliated with the UofL School of Medicine, is actively recruiting adolescent participants who meet criteria for a clinical trial of two inhaled treatments for asthma.

According to the Centers for Disease Control and Prevention, more than 6 million children in the United States have asthma. Even with sufficient symptom management, asthma exacerbations are common in asthmatic children. Exacerbations can result in missed school and limitations on social and physical activity. In extreme cases, they can lead to emergency room visits or hospital admissions. Effective and safe disease management is critical to preventing these situations.

“Our team at Norton Children’s Pulmonology sees an exceptionally high volume of severe asthma cases due to the ‘Ohio Valley effect,’ making us an ideal clinical trial site with a large, diverse patient population,“ said Scott G. Bickel, M.D., pediatric pulmonologist with Norton Children’s Pulmonology and principal investigator for the study. “With more than 2,800 patients under our care for asthma, including many with severe asthma, we have unparalleled access to study participants and specialized expertise in this condition. We’re committed to leveraging this experience to ensure the trial’s success and more effective treatment options to the children who need them most, including the thousands in Kentucky and our surrounding region.”

Norton Children’s is the only trial site in Kentucky enrolling patients for the ACADIA study. The study aims to evaluate 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.

This study addresses the need to control asthma exacerbations in adolescents, particularly those with a history of severe exacerbations. The hope is to reduce the severity and frequency of asthma exacerbations. BDA combines a bronchodilator (albuterol) and a corticosteroid (budesonide) and is administered via rescue metered-dose inhaler. While albuterol alone has been a go-to treatment for many years, combining the medications may offer faster relief during exacerbations.

ACADIA Study Guidelines: Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered as Needed in Participants 12 to < 18 Years of Age with Asthma

The ACADIA study, listed at ClinicalTrials.gov as NCT06307665, is a randomized, double-blind, multicenter, parallel-group Phase 3b study. It is sponsored by AstraZeneca. There are currently 109 sites enrolling in four countries: the United States, China, Mexico and South Africa.

Participation criteria include (but are not limited to):

• Ages 12 to 17 years
• Confirmed clinical diagnosis of asthma for at least 12 months
• Receiving one of the following scheduled asthma maintenance therapies for at least three 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 beta-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 beta-agonist (SABA) as needed
• A documented history of at least one severe asthma exacerbation within 12 months

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 more than three severe asthma exacerbations within 12 months before screening
• Completed treatment for lower respiratory infection and severe asthma exacerbation with systemic corticosteroids within four weeks of screening
• Upper respiratory infection involving antibiotic treatment not resolved