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.

Phase 1

Completed

Interventions: Drug: BDA MDI (PT027) 160/180 μg
Drug: Pulmicort Respules 0.5 MG/ML Inhalation Suspension

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
A/B - Treatment with BDA MDI (PT027) 160/180 μg followed by treatment with Pulmicort Respules 1mg	Pulmicort Respules 0.5 MG/ML Inhalation Suspension	Subjects 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.
A/B - Treatment with BDA MDI (PT027) 160/180 μg followed by treatment with Pulmicort Respules 1mg	BDA MDI (PT027) 160/180 μg	Subjects 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	BDA MDI (PT027) 160/180 μg	Subjects 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.
B/A - Treatment with Pulmicort Respules 1 mg followed by treatment with BDA MDI (PT027) 160/180 μg	Pulmicort Respules 0.5 MG/ML Inhalation Suspension	Subjects 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.

Primary Outcome Measures

Name	Time	Method
AUC0-t	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.	Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration
Cmax	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.	Maximum observed plasma concentration

Secondary Outcome Measures

Name	Time	Method
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.	Drug concentration at last observed (quantifiable) concentration
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.	Time to reach maximum observed plasma concentration
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.	Time of last quantifiable plasma concentration