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A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma

NCT05505734 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2516

Last updated 2025-08-03

Study results available
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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.

Conditions

Interventions

DRUG

BDA MDI

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.

DRUG

AS MDI

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.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Bond Avillion 2 Development LP

    lead INDUSTRY

Principal Investigators

  • Craig LaForce, MD · North Carolina Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-02
Primary Completion
2024-08-22
Completion
2024-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05505734 on ClinicalTrials.gov