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.

Asthma Clinical Trial

— BLANC  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04848662
• Other study ID #: AV006
• Status: Completed
• Phase: Phase 1
• Start date: May 6, 2021
• Est. completion date: July 8, 2021

Study information

• Verified date: April 2022
• Source: Bond Avillion 2 Development LP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 8, 2021
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Male or female aged between 4 and 8 years inclusive (not having reached his/her 9th birthday by the time of screening).

3. Weigh at least 14 kg or higher.

4. Clinician diagnosed asthma of at least 3 months.

5. 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.

6. Demonstrate ability to correctly use the nebulizer and metered-dose inhaler (MDI) device without a spacer.

7. 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.

Exclusion Criteria:

1. Inability to change from any budesonide therapy to another suitable corticosteroid.

2. History of life-threatening asthma defined as any asthma episode associated with loss of consciousness, intubation or admission to an intensive care unit.

3. 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).

4. 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.

5. 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.

6. 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).

7. Upper respiratory infection involving antibiotic treatment not resolved within 14 days prior to Visit 1.

8. Children with a known or suspected hypersensitivity to albuterol/salbutamol, budesonide or any of the excipients used in the IMPs.

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• Pulmicort Respules 0.5 MG/ML Inhalation Suspension
Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide.

Locations

Country	Name	City	State
United States	TTS Research	Boerne	Texas
United States	IPS Research	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Bond Avillion 2 Development LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Tmax	Time to reach 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	Tlast	Time of last quantifiable 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	Clast	Drug concentration at last observed (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.