Status:
COMPLETED
Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma
Lead Sponsor:
Allergan
Collaborating Sponsors:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Conditions:
Asthma
Eligibility:
All Genders
4-11 years
Phase:
PHASE2
Brief 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 evalu...
Eligibility Criteria
Inclusion
- Key
- 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
- Females of child-bearing potential/menarche.
- Diagnosis of any other significant chronic illness or abnormality.
- Use of corticosteroids
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00995904
Start Date
September 1 2009
End Date
November 1 2009
Last Update
January 9 2014
Active Locations (2)
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1
West Coast Clinical Trials LLC
Cypress, California, United States
2
Sylvana Research Associates
San Antonio, Texas, United States