Last updated: 11/04/2018 08:18:45

Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects

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GSK study ID
HZA109912
See study documents
Clinicaltrials.gov ID
NCT00517634
See results summary
EudraCT ID
2007-001345-18
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 12-week, randomised, double-blind, placebo-controlled, three-period, cross-over pilot study comparing the effect of salmeterol/fluticasone propionate, fluticasone propionate and placebo on perpheral blood eosinophils and serum IL-5 in response to allergen challenge in asthma subjects when allergen challenge is administered at 1 hour or 11-12 hours post-dose of the dosing interval
Trial description: The aim of the present study is to investigate whether the effects of salmeterol in combination with fluticasone propionate on blood markers of airway inflammation are maintained after chronic dosing and whether the effect is influenced by the time of allergen challenge relative to the time of dosing.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Weighted Mean Change from baseline over 0-6 hours in blood eosinophils post-Allergen challenge on Day 35

Timeframe: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35

Secondary outcomes:

Weighted mean change from baseline over 0-6 hours in blood eosinophils post-Allergen challenge on Day 14

Timeframe: 0-6 hours, post allergen challenge, 1 hour post treatment, Day 14

Weighted mean change from baseline over 0-6 hours in serum IL-5 post-Allergen challenge on Day 35

Timeframe: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35

Weighted mean change from baseline over 0-6 hours in serum IL-5 Post-Allergen Challenge on Day 14

Timeframe: 0-6 hours post allergen challenge, 1 hour after dosing, Day 14

Interventions:
  • Drug: FP
  • Drug: SFC
  • Drug: Placebo
    • Enrollment:
    23
    Primary completion date:
    2008-23-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    August 2007 to July 2008
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    No
    • Informed consent.
    • Outpatient.
    • History of life-threatening asthma.
    • Use of proscribed asthma medications.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Informed consent.
    • Outpatient.
    • Male or non-pregnant/non-lactating female.
    • Aged 18-55.
    • Diagnosis of asthma.
    • Pre-bronchodilatory FEV1 > 75% predicted.
    • Using inhaled short-acting beta-2-agonists (SABA) with no inhaled corticosteroids.
    • Judged capable of withholding SABA for at least 6 hours prior to visits.
    • Reversibility of >12% and 200mL or PC20 of <8mg/mL.
    • Demonstration of atopy
    Exclusion criteria:
    • History of life-threatening asthma.
    • Use of proscribed asthma medications.
    • Use of anti-histamines or potent inhibitors of CYP3A4.
    • Respiratory tract infection.
    • Asthma exacerbation with 4 weeks of Visit 1.
    • Subjects with exercise induced asthma only.
    • Concurrent respiratory disease.
    • Other clinically significant, uncontrolled condition or disease.
    • Use of any investigational drug within 30 days.
    • Allergic to beta-2-agonists, inhaled corticosteroids or excipients.
    • Positive pregnancy test.
    • Using immunosuppressive medications.
    • Milk protein allergy.
    • Factors likely to interfere with attendance.
    • Current smokers or ex-smokers with a history of >10 pack years.
    • Affiliation wih Investigator site.
    • Medications that may affect the course of asthma or interact with sympathomimetic amines.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Madison, Wisconsin, United States, 53792
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Manchester, United Kingdom, M23 9QZ
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2008-23-07
    Actual study completion date
    2008-23-07

    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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