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Corticosteroid

Budesonide/Albuterol vs Albuterol for Asthma (ACADIA Trial)

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to see if using a specific inhaler, budesonide/albuterol, works better than a regular albuterol inhaler in treating severe asthma attacks in teenagers aged

Who is the study for?
This trial is for adolescents aged 12 to under 18 with asthma, who've had a severe asthma attack in the past year. They must be on stable asthma maintenance therapy for at least 3 months and demonstrate proper inhaler use without spacers. Participants need to perform reliable peak flow measurements and agree to specific contraception methods if applicable.
What is being tested?
The study aims to compare two inhalers: BDA MDI (a combination of budesonide and albuterol) versus AS MDI (albuterol alone), used as needed during severe asthma attacks. It will assess which treatment better prevents exacerbations in young people with a history of serious asthma flare-ups.
What are the potential side effects?
Possible side effects may include throat irritation, headache, rapid heartbeat, nervousness from albuterol; and oral thrush, voice changes, cough or sore throat from budesonide when using the inhalers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annualized rate of severe asthma exacerbations (AAER)
Secondary study objectives
Annualized total systemic corticosteroids (SCS) exposure for treatment of asthma
Apparent total body clearance (CL/F)
Apparent volume of distribution based on the terminal phase (Vz/F)
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Budesonide/albuterol metered -dose inhaler (BDA MDI)Experimental Treatment1 Intervention
Participants will receive BDA MDI 160/180 μg (given as 2 puffs of 80/90 μg) as needed.
Group II: Albuterol sulfate metered-dose inhaler (AS MDI)Active Control1 Intervention
Participants will receive AS MDI 180 μg (given as 2 puffs of 90 μg) as needed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BDA MDI
2022
Completed Phase 3
~2520

Find a Location

Who is running the clinical trial?

ParexelIndustry Sponsor
312 Previous Clinical Trials
101,135 Total Patients Enrolled
20 Trials studying Asthma
39,538 Patients Enrolled for Asthma
AstraZenecaLead Sponsor
4,400 Previous Clinical Trials
289,122,285 Total Patients Enrolled
347 Trials studying Asthma
661,029 Patients Enrolled for Asthma
~293 spots leftby Oct 2027
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