Last updated: 11/04/2018 11:14:43

Study In Airway Physiology In Children SERETIDE DISKUS ® inhlaer and FLIXOTIDE® inhaler are trademarks of GSK group of companies.

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GSK study ID
SAM40100
See study documents
Clinicaltrials.gov ID
NCT00169546
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: Randomised, double-blind parallel group study to assess the bronchodilative and bronchoprotective properties of SERETIDE DISKUS ® inhlaer 50/100mcg twice daily vs. FLIXOTIDE® inhaler 200mcg twice daily.
Trial description: Comparison of two asthma treatments by lung function measures.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

sRAW (k.Pa.s) measured before the study medication dose at the end of treatment (week 6)

Timeframe: N/A

Secondary outcomes:

sRAW measured pre-dose at Week 3. sRAW measured 48 hours after last study medication dose. % symptom-free days over Weeks 1-6. % symptom-free nights over Weeks 1-6. Type and frequency of adverse events.

Timeframe: N/A

Interventions:
  • Drug: Salmeterol/fluticasone propionate
  • Drug: Fluticasone propionate
    • Enrollment:
    64
    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)
    January 2003 to December 2005
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    4 - 11 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Currently receiving 200-800mcg/day beclomethasone dipropionate.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Currently receiving 200-800mcg/day beclomethasone dipropionate.
    • sRAW value of 1.3 kPa's. Exclusion Criteria:
    • 3 or more courses of oral steroids in last 12 months.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Manchester, Lancashire, United Kingdom, M23 9LT
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Wellington, New Zealand, 6004
    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
    2005-20-12

    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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