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A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400608
First Posted: November 17, 2006
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA

Condition Intervention Phase
Asthma Drug: ADVAIR HFA Drug: ADVAIR DISKUS Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Repeat-dose, Open-label, Randomized, Incomplete Block Design in Pediatric Subjects With Asthma, Ages 4 - 11 Years, to Compare Systemic Exposure and Pharmacodynamics of Fluticasone Propionate and Salmeterol Following Advair HFA 45/21mcg (2 Inhalations), ADVAIR® HFA 45/21mcg (2 Inhalations) With Aerochamber Plus Spacer and Advair Diskus 100/50 Twice Daily

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • PD of Fluticasone as measured by serum cortisol followed by doses of ADVAIR HFA and ADVAIR DISKUS [ Time Frame: 3 Weeks ]

Secondary Outcome Measures:
  • To assess the exposure of FP and Salmeterol following the doses of ADVAIR HFA and ADVAIR DISKUS as well as assessing safety measurements based on adverse event reporting [ Time Frame: 3 Weeks ]

Enrollment: 28
Study Start Date: October 2006
Study Completion Date: February 2007
Intervention Details:
    Drug: ADVAIR HFA Drug: ADVAIR DISKUS
    Other Name: ADVAIR HFA
Detailed Description:
A repeat-dose open label randomized incomplete block design in pediatric subjects with asthma, ages 4-11 years, to compare systemic exposure and pharmacodynamics of fluticasone propionate and salmeterol following ADVAIR HFA 45/21mcg(2 inhalations), ADVAIR HFA 45/21mcg(2 inhalations) with Aerochamber Plus Spacer and ADVAIR DISKUS 100/50 twice daily
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subjects with mild asthma
  • No significant medical conditions at screen
  • Weigh at least 20 kg

Exclusion criteria:

  • No clinical abnormalities at screen visit
  • Asthma control at least 3 months prior with anti-steroidal medication only
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400608


Locations
United States, California
GSK Investigational Site
Huntington Beach, California, United States, 92647
GSK Investigational Site
Long Beach, California, United States, 90806
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 97504
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
This study has not been published in the scientific literature.

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: SAS105519
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: SAS105519
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: SAS105519
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: SAS105519
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: SAS105519
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: SAS105519
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SAS105519
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00400608     History of Changes
Other Study ID Numbers: SAS105519
First Submitted: November 15, 2006
First Posted: November 17, 2006
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
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:
pediatrics
ADVAIR Inhaler
Asthma
ADVAIR DISKUS

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics