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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

NCT06502366 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2026-02-13

No results posted yet for this study

Summary

The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma.

Conditions

Interventions

DRUG

BDA MDI HFO 160/180 μg

Budesonide/albuterol pressurized inhalation suspension, HFO

DRUG

BDA MDI HFA 160/180 μg

Budesonide/albuterol pressurized inhalation suspension, HFA

DRUG

Placebo MDI HFA

Placebo pressurized inhalation suspension, HFA

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-22
Primary Completion
2026-03-03
Completion
2026-03-03
FDA Drug
Yes

Countries

  • United States
  • China
  • Malaysia
  • Mexico
  • Thailand
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06502366 on ClinicalTrials.gov