Last updated: 11/04/2018 11:19:28
A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA with Spacer, And ADVAIR DISKUS
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
PD of Fluticasone as measured by serum cortisol followed by doses of ADVAIR HFA and ADVAIR DISKUS
Timeframe: 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
Timeframe: 3 Weeks
Interventions:
Drug: ADVAIR HFA
Drug: ADVAIR DISKUS
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, fluticasone propionate/salmeterol/norflurane, norflurane, salmeterol
Collaborators
Not applicable
Study date(s)
October 2006 to February 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
4 - 11 years
Accepts healthy volunteers
No
- Subjects with mild asthma
- No significant medical conditions at screen
- No clinical abnormalities at screen visit
- Asthma control at least 3 months prior with anti-steroidal medication only
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Will Be Recruiting
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Will Be Recruiting
Location
GSK Investigational Site
Medford, Oregon, United States, 97504
Status
Will Be Recruiting
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-02-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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