A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS
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
1 other identifier
interventional
28
1 country
3
Brief Summary
Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 asthma
Started Oct 2006
Shorter than P25 for phase_4 asthma
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 15, 2006
CompletedFirst Posted
Study publicly available on registry
November 17, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedOctober 28, 2016
October 1, 2016
November 15, 2006
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PD of Fluticasone as measured by serum cortisol followed by doses of ADVAIR HFA and ADVAIR DISKUS
3 Weeks
Secondary Outcomes (1)
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
3 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with mild asthma
- No significant medical conditions at screen
- Weigh at least 20 kg
You may not qualify if:
- No clinical abnormalities at screen visit
- Asthma control at least 3 months prior with anti-steroidal medication only
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (3)
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
Related Publications (1)
This study has not been published in the scientific literature.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2006
First Posted
November 17, 2006
Study Start
October 1, 2006
Study Completion
February 1, 2007
Last Updated
October 28, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.