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BDA MDI

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Aug 13, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment440

FDA Designations

No designations recorded

Clinical trial landscape

BDA MDI · 1 trial · 1 indication

Phase 3 1
NCT06307665Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With AsthmaAsthma
RECRUITING440 Analytics
PHASE3RECRUITING
Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

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.

Secondary Endpoints

Time to first (TTF) severe asthma exacerbation
From Randomization (Day 1) to Week 52 (EOT)
Annualized total systemic corticosteroids (SCS) exposure for treatment of asthma
From Randomization (Day 1) to Week 52 (EOT)
Number of participants with adverse events (AEs) and severe adverse events (SAEs)
Up to Week 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Budesonide/albuterol metered -dose inhaler (BDA MDI)EXPERIMENTALParticipants will receive BDA MDI 160/180 μg (given as 2 puffs of 80/90 μg) as needed.
Albuterol sulfate metered-dose inhaler (AS MDI)ACTIVE_COMPARATORParticipants will receive AS MDI 180 μg (given as 2 puffs of 90 μg) as needed.

Interventions

NameTypeDescription
BDA MDICOMBINATION_PRODUCTParticipants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed.
AS MDICOMBINATION_PRODUCTParticipants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed.
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Eligibility Criteria

Age Range12 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites150

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-d...

Countries:United StatesChinaMexicoSouth Africa
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Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT06307665lastUpdatePostDate: changed
LOWAug 14, 2026NCT06307665lastUpdatePostDate: changed
LOWAug 14, 2026NCT06307665lastUpdatePostDate: changed
LOWJul 14, 2026NCT06307665lastUpdatePostDate: changed
LOWJul 14, 2026NCT06307665lastUpdatePostDate: changed

Frequently asked questions about BDA MDI

What is BDA MDI used for?

BDA MDI is an investigational small molecule being developed for the treatment of asthma. It is currently in Phase 3 clinical development and is being studied in adolescents aged 12 to under 18 years with asthma. The drug is administered as needed and is being evaluated for its efficacy and safety in this patient population.

Who makes BDA MDI?

BDA MDI is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is currently conducting a Phase 3 clinical trial to evaluate the drug's efficacy and safety in adolescent patients with asthma.

What phase is BDA MDI in?

BDA MDI is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants to assess the drug's efficacy and safety in adolescents with asthma.

What clinical trials is BDA MDI in?

BDA MDI is being studied in a Phase 3 clinical trial registered as NCT06307665. This randomized, double-blind, active-controlled study is evaluating the efficacy and safety of BDA MDI compared with PT007 administered as needed in participants aged 12 to under 18 years with asthma. The trial is recruiting 440 participants across the United States, China, Mexico, and South Africa.

How does BDA MDI work?

BDA MDI is a small molecule developed for the treatment of asthma. The specific molecular target of BDA MDI has not been disclosed in the available information. The drug is administered as needed and is being evaluated in a Phase 3 clinical trial for its efficacy and safety in adolescent patients with asthma.