Phase 2
Completed N=25
Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma
Source: ClinicalTrials.gov NCT00995904 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Cmax of Budesonide After Administration of MAP0020 — 92.5; 175; 370 pg/ml
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Budesonide After Administration of MAP0020 |
92.5; 175; 370 | — |
| PRIMARY AUC(0-inf) of Budesonide After Administration of MAP0020 |
3750; 8710; 19400 | — |
| PRIMARY Half-life (t1/2) of Budesonide After Administration of MAP0020 |
53.3; 74.6; 86.9 | — |
Eligibility 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) =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
Data sourced from ClinicalTrials.gov (NCT00995904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.