CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,516 enrolled
Drug / intervention
BDA MDI +1 moredrug
Likely dose
BDA MDI 90 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05505734
NCT05505734Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Parallel-group, Event-driven, Decentralized, Phase IIIb Study Comparing PT027 With PT007 Administered as Needed in Participants 12 Years of Age and Older With Asthma (BATURA)

Bond Avillion 2 Development LP·interventional·Posted Aug 18, 2022·Updated Aug 3, 2025

In Brief

A Phase 3 clinical trial evaluating BDA MDI and AS MDI for Asthma. Completed, enrolled 2,516 participants across 61 sites.

Detailed Summary

This is a US study comparing the efficacy and safety of BDA MDI \[Budesonide/Albuterol Sulfate (BDA) metered dose inhaler (MDI)\] with AS \[Albuterol Sulfate\] MDI, both are administered as needed for up to 12 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
CollaboratorsParexel

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedAug 18, 2022
Enrollment StartSep 2, 2022
Primary CompletionAug 22, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 3.9 years ago

Interventions

BDA MDIdrug

Participants will receive Budesonide and Albuterol Sulfate MDI 80/90 μg per Actuation 1 to 6 doses (2 inhalations/dose) per day as needed via Oral inhalation route.

AS MDIdrug

Participants will receive Albuterol Sulfate MDI 90 μg per Actuation 1 to 6 doses (2 inhalations/dose) per day as needed via Oral inhalation route.