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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

Page last updated: June 20, 2008

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