Last updated: 11/04/2018 07:44:36

A Study To Investigate The Effect Of Inhaled Fluticasone Propionate On The Bronchial Responsiveness To Leukotriene D4 In Asthmatics Patients

GSK study ID
FMS40273
Clinicaltrials.gov ID
NCT00453778
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 study to investigate the effect of inhaled fluticasone propionate on the bronchial responsiveness to leukotriene D4 in asthmatics patients
Trial description: Investigate if asthmatics treated with FLIXOTIDE (FP) 500 mcg BID during 14 days get reduced bronchial reactivity after inhalation of Leukotriene D4. Two 14 days treatment periods where patients received FP 500 MCG BID and placebo. Washout at least 21 days between treatments. Bronchial challenge with methacholine and Leukotriene D4 were performed before the start of each treatment period and on treatment days 13 and 14 respectively.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)
    • Enrollment:
    14
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    fluticasone propionate
    Collaborators
    Not applicable
    Study date(s)
    November 2002 to May 2004
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 50 years
    Accepts healthy volunteers
    No
    • Inclusion:
    • Diagnosed history of asthma
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion:
    • Diagnosed history of asthma
    • Non smoker last two years
    • < 5 pack years
    • FEV1 >70% of predicted
    • Mild and stable asthma
    • Only using short acting b2-agonist as rescue for the last 4 weeks
    • Have a history of atopy. Exclusion:
    • Any significant respiratory disease, other than asthma
    • Subjects with seasonal asthma may not be included if they are in their season
    • Use of oral or inhaled glucocorticosteroid for the last 3 months and long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and antileukotrienes within two weeks
    • Upper or lower RTI within 6 weeks
    • Evidence of any disease that in the investigators mind would affect the results of the study
    • Participating in another study within 4 weeks
    • Females who are pregnant, intend to be or who are lactating
    • Methacholine PD20 > 454mcg
    • Negative scin prick test

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2004-04-05

    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

    Additional information
    Not applicable
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