Do you have a child aged 12 to 17 who has been diagnosed with asthma?
Walgreens and AstraZeneca are seeking volunteers.
Consider your child for the ACADIA clinical trial to assess the effect and safety of new investigational medication on severe asthma exacerbations in adolescents with asthma.
All adolescent participants in this study will receive an investigational treatment with proven efficacy and safety in adults and approved by the FDA for the adult population. It is not approved for adolescents by the FDA and is therefore considered experimental.
The investigational medication will be taken as needed in addition to their current maintenance therapy. Sponsor will provide the study medicine and the Albuterol Sulfate at no cost. Maintenance therapies will not be covered by Sponsor.
Study Overview
Why is the ACADIA study important?
Asthma is a common yet complex lung disease that causes inflammation and narrowing of the airways, leading to reduced airflow in and out of the lungs. This can result in symptoms such as coughing, wheezing and shortness of breath. For adolescents with asthma, it's especially important to manage the condition because they are at a higher risk of having severe asthma attacks. 
When asthma symptoms flare up, an albuterol-only rescue inhaler (AS MDI) can relieve airway tightening, but it does not treat the inflammation that can be an underlying cause. An inhaler that contains budesonide, an inhaled corticosteroid (ICS), in addition to albuterol (BDA MDI), is designed to address both asthma symptoms and the underlying inflammation to potentially prevent severe asthma exacerbations
Your child’s participation could help contribute to the availability of treatment options for adolescents with asthma.
This study is organized and funded by AstraZeneca Pharmaceuticals LP (AZ).
Eligibility Criteria
This study is looking to enroll approximately 440 participants who:
Are 12 to 17 years old
Have a confirmed clinical diagnosis of asthma
Had at least one severe exacerbation in the past year
Are currently being treated with low- to high-dose ICS containing maintenance therapy
There will be other study requirements that the study team will discuss with you.
Taking part in this study involves:
Learning about the details of the study and giving your consent for your child to take part
A screening period that lasts 1 to 4 weeks, a 52-week treatment period, and a follow-up period that lasts 1 to 2 weeks
Attending a total of 8 to 10 study visits
If your child qualifies and your family chooses to join the ACADIA study, your child will be randomly assigned to a study group in which they will receive either an investigational inhaler with budesonide and albuterol (Budesonide/albuterol metered-dose inhaler- BDA MDI), or an inhaler with only albuterol (Albuterol sulfate metered-dose inhaler- AS MDI). Your child will continue taking their current maintenance therapy in addition to the assigned study medicine, as needed.
Whether your child receives investigational budesonide and albuterol inhaler, or an albuterol-only inhaler will be determined randomly (by chance, like flipping a coin).
This study is double-blind, meaning neither you nor the study doctor will know which medication you received until all patients complete the study and the data are analyzed.
Frequently Asked Questions
-
Clinical research is the process of developing therapies to prevent, treat, or help with diseases. Before a medicine can become available, it must be tested in a series of clinical studies to understand if it is safe and effective. With the help of clinical study participants, researchers can find out if and how potential new medicines work.
-
Research process of a new medication goes through different phases. The initial phases focus on safety and determining the appropriate dosage. At this stage, your child will receive an investigational medication with proven safety and efficacy in adults. It is not approved for adolescents by the United States Food and Drug Administration (FDA) and is therefore considered experimental. In this study, we aim to understand how adolescents respond to this therapy. Your child will be closely monitored to minimize the risks of any potential adverse effects.
-
Participants will be in the study for approximately 58 weeks, including a 1-to 4-week screening period followed by a 52-week treatment period and a 1- to 2-week follow-up period. There will be a total of 8 to 10 study visits.
-
BDA MDI combines 2 medicines, a short/rapid-acting beta2-adrenergic agonist (SABA) medicine (albuterol sulfate) and an inhaled corticosteroid (ICS) medicine (budesonide), in 1 inhaler. SABA medicine is a bronchodilator, which help to relax the smooth muscles of the airways, causing them to widen and making it easier to breathe. ICS medicines help to decrease inflammation in the lungs, which is ultimately the cause of breathing difficulties.
-
AS MDI contains only albuterol sulfate, which can help relax the smooth muscles of the airways, causing the airways to widen, leading to easier breathing.
-
Yes. You can decide to stop at any time and for any reason—your child’s care will not be affected in any way.