A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: ADVAIR HFA (Drug); ADVAIR DISKUS (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA
Clinical Details
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), ADVAIRŪ HFA 45/21mcg (2 Inhalations) With Aerochamber Plus Spacer and Advair Diskus 100/50 Twice Daily
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: PD of Fluticasone as measured by serum cortisol followed by doses of ADVAIR HFA and ADVAIR DISKUS
Secondary outcome: 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
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
Minimum age: 4 Years.
Maximum age: 11 Years.
Gender(s): Both.
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
Locations and Contacts
GSK Investigational Site, Huntington Beach, California 92647, United States
GSK Investigational Site, Long Beach, California 90806, United States
GSK Investigational Site, Medford, Oregon 97504, United States
Additional Information
Starting date: October 2006
Last updated: September 5, 2013
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