Status:
COMPLETED
FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
6-12 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to address an Food Drug and Administration (FDA) request to provide safety data in pre-asthmatic patients, ages 6 months to \<12 months, following administration of flutic...
Detailed Description
A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88mcg administered twice-daily for 28 days deliver...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects who have experienced 2 or more wheezing episodes in the previous 6 months.
- Subjects may not have taken any corticosteroids in the 4 weeks prior to dosing
- Parents/guardians should be able to read and comprehend diary information collected throughout the study
- Parents must be able to demonstrate the ability to use the facemask and spacer used to administer study drug
- Exclusion criteria:
- Subjects who weigh less than 7 kg
- Subjects who are taking any drugs that inhibit or induce the cytochrome P450 isoform
- Any parents who have a history of psychiatric disease, intellectual deficiency, substance abuse that would compromise the validity of the consent
Exclusion
Key Trial Info
Start Date :
August 30 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00370097
Start Date
August 30 2006
End Date
April 12 2007
Last Update
September 11 2017
Active Locations (7)
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1
GSK Investigational Site
Huntington Beach, California, United States, 92647
2
GSK Investigational Site
Centennial, Colorado, United States, 80112
3
GSK Investigational Site
Jacksonville, Florida, United States, 32207
4
GSK Investigational Site
Atlanta, Georgia, United States, 30309-7520