Last updated: 11/04/2018 11:18:44

Repeat Dose Study of Fluticasone propionate/salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics

Request patient level data
GSK study ID
SAS10019
See study documents
Clinicaltrials.gov ID
NCT00364442
EudraCT ID
2004-003923-11
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, randomised, double blind, 2-way crossover study to assess the safety and systemic exposure of an investigational formulation compared to concurrent administration of individual Fluticasone Propionate 50 and Salmeterol 50 DISKUS inhalers in subjects aged 18 - 55 years with mild asthma
Trial description: A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone propionate and salmeterol was compared with concurrent administration of fluticasone propionate and salmeterol. Administration occurred over 14 days and tolerability, PK (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

The primary objective was to look at the safety and tolerability of a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol

Timeframe: Administration occurred over 14 days and tolerability

Secondary outcomes:

Comparing changes in PD parameters & PK parameters between a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol

Timeframe: Administration occurred over 14 days and tolerability

Interventions:
  • Drug: fluticasone propionate/salmeterol
    • Enrollment:
    12
    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
    GW857238, fluticasone propionate, fluticasone propionate/salmeterol, salbutamol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    January 2005 to April 2005
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Documented history of mild or intermittent asthma
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Documented history of mild or intermittent asthma
    • Have PEF and FEV1>80% predicted
    • Not a smoker
    • BMI of 19
    • 29 Exclusion criteria:
    • Have had a life threatening episode of asthma
    • Have had a respiratory tract infection in the last four weeks
    • Have other respiratory disease
    • Have taken certain medications within restricted time periods

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14050
    Status
    Study Complete
    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
    2005-13-04

    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

    Participate in clinical trial
    Additional information
    Results for study SAS10019 can be found on the GSK Clinical Study Register.
    Click here
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website