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

GlaxoSmithKline28 enrolled

Overview

Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

ADVAIR HFADRUG

ADVAIR DISKUSDRUG

Eligibility

Sex: ALLMin age: 4 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

Locations (3)

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Medford, Oregon, United States

Outcomes

Primary Outcomes

PD of Fluticasone as measured by serum cortisol followed by doses of ADVAIR HFA and ADVAIR DISKUS

Time frame: 3 Weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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