RecruitingPhase 3

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two inhalers used as needed: budesonide/albuterol and albuterol alone. It tests how well they prevent severe asthma attacks and how safe they are. It is for teens ages 12 to 17 with asthma who had at least one severe attack in the past year.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed asthma diagnosis for at least 12 months and at least one severe asthma attack in the past year.
  • Have used a daily asthma treatment containing an inhaled steroid for at least 3 months, with no dose change in the past month. Only certain added asthma medicines are allowed.
  • Use a quick-relief inhaler as needed and use the albuterol inhaler supplied by the study.
  • Be able to use the study inhaler correctly without a spacer, a tube that helps deliver inhaled medicine.
  • Be able to do repeatable peak flow tests, which measure how fast you can blow air out.
  • Follow the study’s birth control rules and have a negative urine pregnancy test if able to become pregnant.
  • Have a body mass index (BMI), a measure based on height and weight, below 40.
  • Sign a form agreeing to take part and follow study rules. A caregiver must also give written permission before any study procedures.

Who can't join

  • Have had life-threatening asthma, such as an attack involving a breathing tube with high blood carbon dioxide, stopped breathing, seizures from low oxygen, or fainting; or have had more than 3 severe attacks in the past year.
  • Recently finished treatment for a lower lung infection and severe asthma attack with steroids that treat the whole body, within 4 weeks of screening; or have an upper airway infection treated with antibiotics that has not cleared.
  • Currently smoke, stopped less than 6 months ago, or previously smoked more than 10 pack-years, equal to one pack a day for 10 years. Smoking rules include tobacco, vaping, and marijuana.
  • Have another major lung disease, use oxygen, or have another serious medical condition. Cancer must have been in complete remission, with no signs of cancer, for at least 5 years.
  • Have a history of a mental health disorder or a hospital stay for one, or a suicide attempt within the past year; or have major alcohol or drug misuse, as judged by the study doctor.
  • Used steroids by mouth or other steroids that treat the whole body within 4 weeks before the first visit, or used them for at least 3 weeks in the 3 months before that visit.
  • Used a short-acting quick-relief asthma medicine by mouth within the past month.
  • Have a known or suspected allergy to albuterol, also called salbutamol, budesonide, or other ingredients in the inhalers.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (120)

AK

AR

AZ

CA

CO

DE

FL

GA

ID

IL

IN

KS

KY

LA

MA

MD

MI

MN

MO

MT

NC

NE

NJ

NM

NY

OH

OK

PA

SC

SD

TN

TX

UT

VA

VT

WA