Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma

Allergan

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: 21ug MAP0020; Drug: 84ug MAP0020; Drug: 42ug MAP0020

Study type: Interventional

Funder types: Industry

Identifiers

NCT00995904

MAP0020-CL-P201

Details and patient eligibility

About

This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery.

Enrollment: 25 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Male or female children with a documented diagnosis of mild-to-moderate persistent asthma (according to the 2007 NIH [EPR] criteria) for at least 1 year prior to screening and medically stable for a minimum of 6 months prior to screening.
2. Children 4 through 11 years old (up to one day prior to their 12th birthday at randomization).
3. Body weight >=45 lbs, body mass index (BMI) <=30 kg/m2
4. ICS users had to have been taking an ICS for >=3 months and on a stable dose for >= 1 month before Visit 1.ICS users had to be stable enough and able to withhold their therapeutic ICS for 24 hours prior to study drug administration,
5. Subjects already on stable immunotherapy (ie, allergy shots)if not anticipated to change during the study.

Key Exclusion Criteria:

1. Females of child-bearing potential/menarche.
2. Diagnosis of any other significant chronic illness or abnormality.
3. Use of corticosteroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 6 patient groups

Treatment A, then Treatment B, then Treatment C

Experimental group

Description:

Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4

Treatment:

Drug: 42ug MAP0020

Drug: 84ug MAP0020

Drug: 21ug MAP0020

Treatment A, then Treatment C, then Treatment B

Experimental group

Description:

Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4

Treatment:

Drug: 42ug MAP0020

Drug: 84ug MAP0020

Drug: 21ug MAP0020

Treatment B, then Treatment A, then Treatment C

Experimental group

Description:

Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4

Treatment:

Drug: 42ug MAP0020

Drug: 84ug MAP0020

Drug: 21ug MAP0020

Treatment B, then Treatment C, then Treatment A

Experimental group

Description:

Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 4

Treatment:

Drug: 42ug MAP0020

Drug: 84ug MAP0020

Drug: 21ug MAP0020

Treatment C, then Treatment A, then Treatment B

Experimental group

Description:

Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4

Treatment:

Drug: 42ug MAP0020

Drug: 84ug MAP0020

Drug: 21ug MAP0020

Treatment C, then Treatment B, then Treatment A

Experimental group

Description:

Study visits were separated by 3-7 day intervals. Treatment C: 21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 2; Treatment B: 42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 3; Treatment A: 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 4

Treatment:

Drug: 42ug MAP0020

Drug: 84ug MAP0020

Drug: 21ug MAP0020