BDA MDI: Participants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed.
AS MDI: Participants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed.
Study summary
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.
Eligibility
Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Annualized rate of severe asthma exacerbations (AAER) — From Randomization (Day 1) to Week 52 (EOT) The effect of BDA MDI compared with AS MDI, both administered as needed, on the AAER in participants with asthma will be evaluated.
Trial sites (150)
Facility
City
Region
Status
Research Site
Anchorage
Alaska
Recruiting
Research Site
Gilbert
Arizona
Recruiting
Research Site
Phoenix
Arizona
Recruiting
Research Site
Little Rock
Arkansas
Completed
Research Site
Huntington Beach
California
Not Yet Recruiting
Research Site
Huntington Beach
California
Not Yet Recruiting
Research Site
Long Beach
California
Recruiting
Research Site
Long Beach
California
Recruiting
Research Site
Madera
California
Not Yet Recruiting
Research Site
Mission Viejo
California
Recruiting
Research Site
Moreno Valley
California
Recruiting
Research Site
Orange
California
Recruiting
Research Site
Redondo Beach
California
Not Yet Recruiting
Research Site
Riverside
California
Recruiting
Research Site
San Diego
California
Recruiting
Research Site
San Diego
California
Not Yet Recruiting
Research Site
San Francisco
California
Withdrawn
Research Site
Westminster
California
Recruiting
Research Site
Denver
Colorado
Recruiting
Research Site
Wilmington
Delaware
Recruiting
Research Site
Destin
Florida
Recruiting
Research Site
Jacksonville
Florida
Recruiting
Research Site
Kendall
Florida
Not Yet Recruiting
Research Site
Largo
Florida
Completed
Research Site
Miami
Florida
Not Yet Recruiting
Research Site
Miami
Florida
Not Yet Recruiting
Research Site
Miami
Florida
Recruiting
Research Site
Miami
Florida
Recruiting
Research Site
Pembroke Pines
Florida
Not Yet Recruiting
Research Site
Tampa
Florida
Withdrawn
Research Site
Atlanta
Georgia
Recruiting
Research Site
Columbus
Georgia
Recruiting
Research Site
Fayetteville
Georgia
Recruiting
Research Site
Snellville
Georgia
Recruiting
Research Site
Meridian
Idaho
Withdrawn
Research Site
Normal
Illinois
Recruiting
Research Site
River Forest
Illinois
Withdrawn
Research Site
Indianapolis
Indiana
Recruiting
Research Site
Kansas City
Kansas
Recruiting
Research Site
Louisville
Kentucky
Recruiting
+ 110 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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