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

Asthma Clinical Trial

Official title:

PD of Hydrofluoroalkane Propellant of Inhaled Fluticasone Propionate Following Administration in Pediatric Subjects 6-12 Months of Age With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370097
• Other study ID #: FAS106533
• Status: Completed
• Phase: Phase 1
• First received: August 28, 2006
• Last updated: September 7, 2017
• Start date: August 30, 2006
• Est. completion date: April 12, 2007

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 fluticasone propionate HFA.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 12, 2007
• Est. primary completion date: April 12, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• FLOVENT (fluticasone propionate) HFA
FLOVENT HFA consists of a white to off-white suspension of FP (micronized) in a liquefied hydrofluoroalkane propellant, 1,1,1,2-tetrafluoroethane. Subject will receive FP HFA using an Aerochamber Plus with Infant Mask.
• Placebo HFA
Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Centennial	Colorado
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Normal	Illinois
United States	GSK Investigational Site	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum cortisol weighted mean(0-12h)		throughout the study
Secondary	Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events		throughout the study

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study FAS106533 can be found on the GSK Clinical Study Register.