A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
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, MD, 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), ADVAIR HFA 45/21mcg(2 Inhalations) With Aerochamber Plus Spacer and ADVAIR DISKUS 100/50 Twice Daily
Study design: Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study
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
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 Clinical Trials Call Center, Long Beach, California 90806, United States
GSK Clinical Trials Call Center, Huntington Beach, California 92647, United States
GSK Clinical Trials Call Center, Jacksonville, Florida 32207, United States
GSK Clinical Trials Call Center, Medford, Oregon 97504, United States
Additional Information
Starting date: November 2006
Ending date: July 2007
Last updated: October 26, 2007
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