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BDA MDI HFO 160/180 μg

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment422

FDA Designations

No designations recorded

Clinical trial landscape

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
ACTIVE NOT_RECRUITING422 Analytics
PHASE3ACTIVE NOT_RECRUITING
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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Frequently asked questions about BDA MDI HFO 160/180 μg

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

BDA MDI HFO 160/180 μg is an investigational small molecule being developed for the treatment of asthma. It is a metered-dose inhaler formulation of budesonide, a corticosteroid, using a next-generation propellant. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.

What does BDA MDI HFO 160/180 μg target?

BDA MDI HFO 160/180 μg contains budesonide, a corticosteroid that works by reducing inflammation in the airways. It is designed to be delivered via a metered-dose inhaler using a next-generation propellant. The drug is being studied for its effect on lung function in patients with asthma.

Who makes BDA MDI HFO 160/180 μg?

BDA MDI HFO 160/180 μg is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting a Phase 3 clinical trial to evaluate the drug's efficacy and safety in patients with asthma.

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

BDA MDI HFO 160/180 μg is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is active but not recruiting participants, with an enrollment of 422 patients.

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

BDA MDI HFO 160/180 μg is being studied in a Phase 3 clinical trial registered as NCT06502366. This randomized, double-blind, placebo-controlled trial is investigating the effect on lung function of BDA formulated with a next-generation propellant compared with an approved asthma treatment. The trial is active but not recruiting, with 422 participants.

Is BDA MDI HFO 160/180 μg the same as budesonide?

BDA MDI HFO 160/180 μg is a formulation of budesonide, a corticosteroid used to treat asthma. It is delivered via a metered-dose inhaler using a next-generation propellant, which distinguishes it from other budesonide inhalers that use traditional propellants. The drug is being developed to potentially offer an alternative to existing treatments.