Skip to main content
OpenTrials
Completed

NCT Number: NCT00370097

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Huntington Beach, California, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FLOVENT (fluticasone propionate) HFA

Drug

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

Drug

Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.

Primary outcomes

  1. Serum cortisol weighted mean(0-12h)

    Time frame: throughout the study

Secondary outcomes

  1. Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 30, 2006
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.