NCT03847896

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,001 (actual)
• Sponsor: Bond Avillion 2 Development LP · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose)	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)
COMBINATION_PRODUCT	Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose)	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)
DRUG	Budesonide metered dose inhaler / BD MDI 160 µg	Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)
DRUG	Albuterol sulfate metered dose inhaler / AS MDI 180 μg	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)
OTHER	Placebo metered-dose inhaler / Placebo MDI	Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)

Timeline

• Start date: 2019-03-20
• Primary completion: 2021-07-20
• Completion: 2021-07-20
• First posted: 2019-02-20
• Last updated: 2023-04-13
• Results posted: 2022-09-30

Locations

129 sites across 7 countries: United States, Argentina, Czechia, Germany, Serbia, Slovakia, Ukraine

Regulatory

• FDA-regulated drug study