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

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: FLOVENT (fluticasone propionate) HFA	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	See Detailed Description

Resource links provided by NLM:

Drug Information available for: Fluticasone propionate Fluticasone Fluticasone furoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	16
Study Start Date:	August 2006

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

Eligibility


Ages Eligible for Study:	6 Months to 12 Months (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370097

Locations


United States, California
GSK Investigational Site
Huntington Beach, California, United States, 92647
United States, Colorado
GSK Investigational Site
Centennial, Colorado, United States, 80112
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32207
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30309-7520
United States, Illinois
GSK Investigational Site
Normal, Illinois, United States, 61761
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75230

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information


Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00370097 History of Changes
Other Study ID Numbers:	FAS106533
Study First Received:	August 28, 2006
Last Updated:	May 15, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:


Asthma infants FLOVENT spacer

Additional relevant MeSH terms:


Fluticasone Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 26, 2016