CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,132 enrolled
Drug / intervention
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg +2 morecombination
Likely dose
Budesonide/albuterol sulfate metered-dose inhaler 160/180 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/NCT03769090
NCT03769090Phase 3Completed
CompareCT.gov

A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma

Bond Avillion 2 Development LP·interventional·Posted Dec 7, 2018·Updated Sep 28, 2022

In Brief

A Phase 3 clinical trial evaluating Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg, Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg, and 1 other intervention for Asthma. Completed, enrolled 3,132 participants across 345 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Canada, Czechia, Germany, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 7, 2018
Enrollment StartDec 13, 2018
Primary CompletionAug 19, 2021
Study CompletionFeb 7, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.6 years ago

Interventions

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

Budesonide/albuterol sulfate combination inhalation aerosol

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

Budesonide/albuterol sulfate combination inhalation aerosol

Albuterol sulfate metered-dose inhaler 180 μgdrug

Albuterol sulfate inhalation aerosol