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Corticosteroid

Budesonide/albuterol metered -dose inhaler (BDA MDI) for Asthma (ACADIA Trial)

Phase 3

Waitlist Available

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

ACADIA 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.Check my eligibility

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.See study design

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.

ACADIA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Annualized rate of severe asthma exacerbations (AAER)

Secondary outcome measures

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

ACADIA 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

ParexelIndustry Sponsor

304 Previous Clinical Trials

100,712 Total Patients Enrolled

20 Trials studying Asthma

39,655 Patients Enrolled for Asthma

AstraZenecaLead Sponsor

4,274 Previous Clinical Trials

288,612,981 Total Patients Enrolled

328 Trials studying Asthma

638,700 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study have a minimum age requirement of 20 years for participant enrollment?

"This study is seeking participants aged 12 to under 17 years old for enrollment."

Answered by AI

Am I eligible to participate in this clinical trial?

"This trial aims to recruit 440 individuals aged between 12 and 17 who are currently managing asthma. Eligible participants must meet the subsequent criteria: Have been consistently prescribed one of the following therapies for maintaining asthma control for a minimum of 3 months with stable dosages over the past month - Inhaled corticosteroids (ICS) at varying doses, Utilize inhaled short-acting β2-agonist (SABA) on an as-needed basis, Present documented evidence of experiencing at least one severe asthma exacerbation within the last year, Employ albuterol sulfate inhalation aerosol provided by the sponsor, Demonstrate"

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"Information found on clinicaltrials.gov reveals that this specific medical trial is not in the recruitment phase. The study was first listed on 5/8/2024 and last updated on 4/8/2024. Despite its closed recruitment status, there are currently 316 other trials actively seeking participants."

Answered by AI

Has the Budesonide/albuterol metered-dose inhaler (BDA MDI) been given official approval by the FDA?

"The safety assessment of Budesonide/albuterol metered-dose inhaler (BDA MDI) is rated as 3 by our team at Power, aligning with the Phase 3 trial status. This rating suggests there is existing efficacy data and extensive safety evidence to support its use in clinical trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06307665.