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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00370097
First received: August 28, 2006
Last updated: October 26, 2016
Last verified: October 2016
  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: PD of Hydrofluoroalkane Propellant of Inhaled Fluticasone Propionate Following Administration in Pediatric Subjects 6-12 Months of Age With Asthma

Resource links provided by NLM:


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 ]

Enrollment: 16
Study Start Date: August 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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 GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: FAS106533
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: FAS106533
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: FAS106533
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: FAS106533
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: FAS106533
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: FAS106533
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: FAS106533
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00370097     History of Changes
Other Study ID Numbers: FAS106533 
Study First Received: August 28, 2006
Last Updated: October 26, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Asthma infants FLOVENT spacer

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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 December 07, 2016