FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects

Verified by: GlaxoSmithKline, May 2009
First Received: August 28, 2006 | Last Updated: May 15, 2009 | Phase: Phase 1 | Start Date: August 2006
Overall Status: Completed | Estimated Enrollment: 16
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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...

Brief Summary

Official Title: “See Detailed Description”

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: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary Measures

  • Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events
    • 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 Investigator Information

Lead Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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