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.
BLANC
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)
1 other identifier
interventional
12
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 asthma
Started May 2021
Shorter than P25 for phase_1 asthma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2021
CompletedFirst Posted
Study publicly available on registry
April 19, 2021
CompletedStudy Start
First participant enrolled
May 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2021
CompletedResults Posted
Study results publicly available
April 7, 2022
CompletedMay 11, 2022
April 1, 2022
2 months
April 1, 2021
February 7, 2022
April 12, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
AUC0-t
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration
A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing.
Cmax
Maximum observed plasma concentration
A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing.
Secondary Outcomes (3)
Tmax
A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing.
Tlast
A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing.
Clast
A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing.
Study Arms (2)
A/B - Treatment with BDA MDI (PT027) 160/180 μg followed by treatment with Pulmicort Respules 1mg
EXPERIMENTALSubjects randomized to receive a single dose of budesonide/albuterol by metered-dose inhaler, BDA MDI, (PT027) 160/180 μg at Visit 2, and a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 3.
B/A - Treatment with Pulmicort Respules 1 mg followed by treatment with BDA MDI (PT027) 160/180 μg
EXPERIMENTALSubjects randomized to receive a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 2, and a single dose of budesonide/albuterol by metered-dose inhaler, BDA MDI, (PT027) 160/180 μg at Visit 3.
Interventions
Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose.
Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide.
Eligibility Criteria
You may qualify if:
- Provision of informed consent prior to any study specific procedures. Children should provide assent to join the study, as applicable. The child's parent(s) or legally authorized representative (LAR) must sign the informed consent form (ICF). The LAR must be aged ≥18 years old.
- Male or female aged between 4 and 8 years inclusive (not having reached his/her 9th birthday by the time of screening).
- Weigh at least 14 kg or higher.
- Clinician diagnosed asthma of at least 3 months.
- Stable on treatment with albuterol PRN and/or ICS and/or leukotriene receptor antagonists (LTRAs) for 2 weeks prior to screening; children taking budesonide in any form at Visit 1 will be switched to another corticosteroid with a washout of budesonide of 3 to 7 days.
- Demonstrate ability to correctly use the nebulizer and metered-dose inhaler (MDI) device without a spacer.
- Willingness and ability of the child and parent(s)/LAR to comply with the demands of the study as described in the informed consent/assent.
You may not qualify if:
- Inability to change from any budesonide therapy to another suitable corticosteroid.
- History of life-threatening asthma defined as any asthma episode associated with loss of consciousness, intubation or admission to an intensive care unit.
- Unstable asthma as judged by the Investigator (eg, any change in asthma therapy within 2 weeks prior to screening or use of more than 2 occasions of rescue medication (albuterol) per day within 1 week prior to screening (potential for rescreen).
- Children receiving regular maintenance treatment with prohibited anti-inflammatory or long-acting bronchodilator asthma medication (inhaled, nebulized, oral, or systemic) within 1 month prior to screening.
- More than 1 short course of oral/rectal/systemic corticosteroids within 6 months preceding screening (Visit 1), or any oral/rectal/systemic corticosteroids within 30 days prior to screening.
- Evidence of active concomitant pulmonary disease other than asthma (children with stable allergic rhinitis will be permitted, as long as, there are no changes in the treatment and the medications do not interfere with the analytical assay methods).
- Upper respiratory infection involving antibiotic treatment not resolved within 14 days prior to Visit 1.
- Children with a known or suspected hypersensitivity to albuterol/salbutamol, budesonide or any of the excipients used in the IMPs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
IPS Research
Oklahoma City, Oklahoma, 73106, United States
TTS Research
Boerne, Texas, 78006, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Avillion LLP
Study Officials
- STUDY DIRECTOR
Frank Albers, MD, PhD
Avillion LLP
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2021
First Posted
April 19, 2021
Study Start
May 6, 2021
Primary Completion
July 5, 2021
Study Completion
July 8, 2021
Last Updated
May 11, 2022
Results First Posted
April 7, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share
No plans to share IPD