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

Tracking Information

First Received Date ^ICMJE

August 28, 2006

Last Updated Date

May 15, 2009

Start Date ^ICMJE

August 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Serum cortisol weighted mean(0-12h) [ Time Frame: throughout the study ]

Original Primary Outcome Measures ^ICMJE

Serum cortisol weighted mean(0-12h)

Change History

Complete list of historical versions of study NCT00370097 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events [ Time Frame: throughout the study ]

Original Secondary Outcome Measures ^ICMJE

Serum cortisol Cmin
FP Cmaxss, AUClast and tmaxss
Adverse events

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

See Detailed Description

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 fluticasone propionate HFA.

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 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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: FLOVENT (fluticasone propionate) HFA

Other Name: FLOVENT (fluticasone propionate) HFA

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

6 Months to 12 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00370097

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

FAS106533

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP