NCT04848662

To Compare the Pharmacokinetics of Budesonide Delivered by BDA MDI to Budesonide Delivered by Pulmicort Respules in Children With Asthma Aged 4 to 8 Years.

A Phase I, Randomized, Open-label, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics of Budesonide Delivered by PT027 to Pulmicort Respules® in Children With Asthma Aged 4 to 8 Years (BLANC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Bond Avillion 2 Development LP · Industry
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

To compare the pharmacokinetics of budesonide delivered by BDA MDI to budesonide delivered by Pulmicort Respules in children with Asthma aged 4 to 8 years.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	BDA MDI (PT027) 160/180 μg	Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose.
DRUG	Pulmicort Respules 0.5 MG/ML Inhalation Suspension	Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide.

Timeline

• Start date: 2021-05-06
• Primary completion: 2021-07-05
• Completion: 2021-07-08
• First posted: 2021-04-19
• Last updated: 2022-05-11
• Results posted: 2022-04-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study