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

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GSK study ID
SAS105519
See study documents
Clinicaltrials.gov ID
NCT00400608
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    • Inclusion criteria:
    • Subjects with mild asthma
    Inclusion and exclusion criteria
    Inclusion 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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Huntington Beach, California, United States, 92647
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Long Beach, California, United States, 90806
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Medford, Oregon, United States, 97504
    Status
    Will Be Recruiting
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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.

    Additional information about the trial

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