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RecruitingPhase 3interventionalRules rewrite

Phase 3: BDA MDI for Asthma

This study wants 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.

Official registry: https://clinicaltrials.gov/study/NCT06307665 · AstraZeneca · enrollment listed as 440

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are BDA MDI, or AS MDI. The registry lists allocation as randomized. This study wants 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.

They plan to enroll about 440 people at 123 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

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)

Interventions: BDA MDI, AS MDI

Primary outcome (registry wording): Annualized rate of severe asthma exacerbations (AAER)

Who it is for (from inclusion criteria)

  • Ages 12 Years to 17 Years
  • 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
  • Low-to-high-dose Inhaled corticosteroid(s) (ICS)
  • 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

Public study contact (from the registry)

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

123 listed

+ 26 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06307665 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06307665?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06307665?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary