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A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma

NCT03769090 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3132

Last updated 2022-09-28

Study results available
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Summary

This is a randomized, double-blind, multicenter, parallel-group, variable-length study to compare 2 doses of BDA MDI (PT027) with AS MDI (PT007) on the time to first severe asthma exacerbation in adult, adolescent, and pediatric subjects with moderate to severe asthma.

Conditions

Interventions

COMBINATION_PRODUCT

Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg

Budesonide/albuterol sulfate combination inhalation aerosol

COMBINATION_PRODUCT

Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg

Budesonide/albuterol sulfate combination inhalation aerosol

DRUG

Albuterol sulfate metered-dose inhaler 180 μg

Albuterol sulfate inhalation aerosol

Sponsors & Collaborators

  • Bond Avillion 2 Development LP

    lead INDUSTRY

Principal Investigators

  • Frank Albers, MD, PhD · Avillion LLP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-13
Primary Completion
2021-08-19
Completion
2022-02-07
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Czechia
  • Germany
  • Serbia
  • Slovakia
  • South Africa
  • Spain
  • Ukraine
  • United Kingdom

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 NCT03769090 on ClinicalTrials.gov