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BDA MDI HFO 160/180 μg

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Trials Updated: Sep 8, 2026

BDA MDI HFO 160/180 μg development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jul 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment424

FDA Designations

No designations recorded

BDA MDI HFO 160/180 μg clinical trials

BDA MDI HFO 160/180 μg · 1 trial · 1 indication

Phase 3 1
NCT06502366A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With AsthmaAsthma
COMPLETED424 Analytics
PHASE3COMPLETED
A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in peak FEV1 in 0-60 minutes after dosing at Day 29
Change from baseline at Day 29

To assess the equivalence of BDA MDI HFO relative to BDA MDI HFA on lung function in participants with asthma.

Secondary Endpoints

Change from baseline in morning pre-dose trough FEV1
Change from baseline at Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BDA MDI HFOACTIVE_COMPARATOR160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFO
BDA MDI HFAACTIVE_COMPARATOR160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFA
Placebo MDI HFAPLACEBO_COMPARATORPlacebo pressurized inhalation suspension, HFA

Interventions

NameTypeDescription
BDA MDI HFO 160/180 μgDRUGBudesonide/albuterol pressurized inhalation suspension, HFO
BDA MDI HFA 160/180 μgDRUGBudesonide/albuterol pressurized inhalation suspension, HFA
Placebo MDI HFADRUGPlacebo pressurized inhalation suspension, HFA
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites128

Inclusion Criteria: * Participant must be ≥ 18 years of age at the time of signing the ICF. * Participants who have physician diagnosed asthma as defined by GINA for at least 12 months prior to Visit 1. * Eligible participants are on either a) no daily inhaled maintenance therapy or b) daily inhale...

Countries:United StatesChinaMalaysiaMexicoThailandVietnam
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Recent Changes (Last 90 Days)

MEDIUMOct 9, 2026NCT06502366TRIAL_REMOVED: changed
MEDIUMOct 9, 2026NCT06502366TRIAL_REMOVED: changed
HIGHSep 8, 2026NCT06502366Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHSep 8, 2026NCT06502366Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about BDA MDI HFO 160/180 μg

What is BDA MDI HFO 160/180 μg?

BDA MDI HFO 160/180 μg is an investigational inhaled asthma therapy developed by AstraZeneca PLC. It is a small molecule delivered by metered dose inhaler (MDI) using HFO, a next generation propellant, at 160/180 μg. It is being studied as a potential alternative to an approved asthma treatment that uses HFA propellant.

What is BDA MDI HFO 160/180 μg used for?

BDA MDI HFO 160/180 μg is being developed for the treatment of asthma. Its Phase 3 trial enrolled adults with asthma to assess lung function compared with an approved asthma treatment formulated with HFA propellant. The drug remains investigational and is not established as a marketed therapy.

Who makes BDA MDI HFO 160/180 μg?

AstraZeneca PLC (ticker AZN) is the developer of BDA MDI HFO 160/180 μg. The company is running the clinical program for this next generation propellant formulation in asthma.

What phase is BDA MDI HFO 160/180 μg in?

BDA MDI HFO 160/180 μg is in Phase 3 development for asthma. One Phase 3 trial has been completed, and no trials are currently listed as active. The drug is investigational and has not been approved by the FDA.

What clinical trials is BDA MDI HFO 160/180 μg in?

BDA MDI HFO 160/180 μg has been studied in Phase 3 trial NCT06502366, titled a study to investigate the effect on lung function of BDA formulated with a next generation propellant compared with an approved asthma treatment (BDA with HFA propellant) in participants with asthma. The trial is completed and enrolled 424 participants.

How was the Phase 3 trial of BDA MDI HFO 160/180 μg designed?

The Phase 3 trial NCT06502366 was a randomized, double-blind, placebo-controlled study in 424 adults with asthma, aged 18 years and older, across the United States, China, Malaysia, Mexico, Thailand, and Vietnam. It compared BDA formulated with a next generation propellant against an approved asthma treatment using HFA propellant.