CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,001 enrolled
Drug / intervention
Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose) +4 morecombination
Likely dose
Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose)from 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/NCT03847896
NCT03847896Phase 3Completed
CompareCT.gov

A 12-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT008 and PT007 Administered QID in Adults and Children 4 Years of Age or Older With Asthma

Bond Avillion 2 Development LP·interventional·Posted Feb 20, 2019·Updated Apr 13, 2023

In Brief

A Phase 3 clinical trial evaluating Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose), Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose), and 3 other interventions for Asthma. Completed, enrolled 1,001 participants across 129 sites in 7 countries.

Detailed Summary

This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study to compare 2 dose levels of budesonide/albuterol BDA MDI (PT027) to its components budesonide BD MDI (PT008) and albuterol AS MDI (PT007) on improvement in lung function and asthma symptoms after 12 weeks of treatment in adult, adolescent, and child subjects with symptomatic asthma currently being treated with a short/rapid-acting β2-adrenoreceptor agonist (SABA) as needed alone or with low-dose inhaled corticosteroid (ICS) maintenance therapy plus SABA as needed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Czechia, Germany, Serbia, Slovakia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 20, 2019
Enrollment StartMar 20, 2019
Primary CompletionJul 20, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.4 years ago

Interventions

Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose)combination

Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)

Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose)combination

Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)

Budesonide metered dose inhaler / BD MDI 160 µgdrug

Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)

Albuterol sulfate metered dose inhaler / AS MDI 180 μgdrug

Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)

Placebo metered-dose inhaler / Placebo MDIother

Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)