At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
BDA MDI (PT027) 160/180 μg +1 moredrug
Likely dose
BDA MDI (PT027) 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.
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)
In Brief
A Phase 1 clinical trial evaluating BDA MDI (PT027) 160/180 μg and Pulmicort Respules 0.5 MG/ML Inhalation Suspension for Asthma. Completed, enrolled 12 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedApr 2021
Enrollment StartMay 2021
Primary CompletionJul 2021
Study CompletionJul 2021
TodayJul 2026
First PostedApr 19, 2021
Enrollment StartMay 6, 2021
Primary CompletionJul 5, 2021
Study CompletionJul 8, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.2 years ago
Interventions
BDA MDI (PT027) 160/180 μgdrug
Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose.
Pulmicort Respules 0.5 MG/ML Inhalation Suspensiondrug
Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide.