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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.

NCT04848662 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-05-11

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Bond Avillion 2 Development LP

    lead INDUSTRY

Principal Investigators

  • Frank Albers, MD, PhD · Avillion LLP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2021-07-05
Completion
2021-07-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04848662 on ClinicalTrials.gov