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

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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:

  • 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.
  • Children 4 through 11 years old (up to one day prior to their 12th birthday at randomization).
  • Body weight >=45 lbs, body mass index (BMI) <=30 kg/m2
  • 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,
  • Subjects already on stable immunotherapy (ie, allergy shots)if not anticipated to change during the study.

Key Exclusion Criteria:

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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