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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:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00400608
First received: November 15, 2006
Last updated: May 31, 2012
Last verified: March 2011
History of Changes
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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 Names:
    • ADVAIR HFA
    • ADVAIR DISKUS
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

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00400608     History of Changes
Other Study ID Numbers: SAS105519
Study First Received: November 15, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

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, salmeterol drug combination
Albuterol
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Tocolytic Agents
Reproductive Control Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on June 18, 2013