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 fluticasone propionate HFA...
Date First Received: August 28, 2006
Last Updated: October 15, 2008
Verified by: GlaxoSmithKline, October 2008
Clinical Trial Phase: Phase 1 | Start Date: August 2006
Overall Status: Completed
Estimated Enrollment: 16
Brief Summary
Official Title: “See Detailed Description”
Condition Keyword(s):
Intervention(s):
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 fluticasone propionate HFA.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacodynamics Study
Detailed Clinical Trial 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 delivered via an MDI and valved holding chamber with infant facemask to subjects ages 6 months to <12 months who have experienced 2 or more wheezing episodes in the preceding 6 months
Intervention(s) in this Clinical Trial
- Drug: FLOVENT (fluticasone propionate) HFA
Outcome Measures for this Clinical Trial
Primary Measures
- Serum cortisol weighted mean(0-12h)
- Time Frame: throughout the study
- Time Frame: throughout the study
Secondary Measures
- Serum cortisol Cmin
FP Cmaxss, AUClast and tmaxss
Adverse events
- Time Frame: throughout the study
- Time Frame: throughout the study
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Months
Maximum Age for this Clinical Trial: 12 Months
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on January 08, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00370097
Study ID Number: FAS106533
ClinicalTrials.gov Identifier: NCT00370097
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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