Last updated: 11/04/2018 11:21:50

Advair Pediatric Once-Daily

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GSK study ID
SAS30021
See study documents
Clinicaltrials.gov ID
NCT00920959
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 stratified, randomized, double-blind, placebo-controlled, parallel-group, 12 week trial evaluating the safety and efficacy of fluticasone propionate/salmeterol DISKUS combination product 100/50mcg once daily versus fluticasone propionate DISKUS 100mcg once daily and placebo in symptomatic pediatric subjects (4-11 years) with asthma
Trial description: To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from baseline at endpoint in daily PM PEF

Timeframe: 12 weeks

Secondary outcomes:

Various pulmonary function endpoints

Timeframe: 12 weeks

Interventions:
  • Drug: FP 100mcg
  • Drug: FSC 100/50mcg
  • Drug: Placebo
    • Enrollment:
    908
    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, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    November 2001 to January 2004
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    4 - 11 years
    Accepts healthy volunteers
    No
    • Out-patients
    • Asthma diagnosis
    • Life-threatening asthma
    • Specified asthma medications
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Out-patients
    • Asthma diagnosis
    • Reversibility
    • Short-acting beta-agonist or asthma controlled medication use
    Exclusion criteria:
    • Life-threatening asthma
    • Specified asthma medications
    • Chickenpox
    • Drug allergy
    • Respiratory infections
    • Tobacco use
    • Clinical laboratory abnormalities
    • Ophthalmologic conditions
    • Investigation medications
    • Affiliation with investigator site

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Vista, California, United States, 92084
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Sunset, Louisiana, United States, 70584
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Dinuba, California, United States, 93618
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Murray, Utah, United States, 84107
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Edmonds, Washington, United States, 98026
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40222
    Status
    Recruiting
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    Showing 1 - 6 of 149 Results

    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
    2004-03-01

    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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