Last updated: 11/04/2018 08:18:07

Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.

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GSK study ID
HZA108799
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Clinicaltrials.gov ID
NCT00444509
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 double-blind, placebo-controlled, crossover study to investigate the safety, tolerability and pharmacokinetics of single dose dry powder GW685698X containing magnesium stearate in subjects with mild to moderate asthmatic patients
Trial description: This is a single centre, randomised, double blind, two-way crossover study, to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder GW685698X (800?g) containing magnesium stearate. Magnesium stearate is an excipient added to improve the physical stability of inhaled dry powder formulations. Male and female patients with mild/moderate asthma will be randomised to determine which order they receive a single inhaled administration of GW685698X (800?g) with and without magnesium stearate. There will be a wash-out period of at least 5 days between doses.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Safety and tolerability: Vital signs: for 48 hours 12-lead ECG including QT, QTc, PR and QRS intervals for 48 hours PEFR, FEV1 for 48 hours Laboratory safety tests (clinical chemistry, haematology, urinalysis) at predose Adverse events for 46 days

Timeframe: Vital signs: for 48 hours

Secondary outcomes:

Plasma GW685698X concentrations and pharmacokinetic parameters (AUC, Cmax, t1/2, tmax) following single inhaled doses in mild/moderate asthmatic patients for 48 hours. Weighted mean serum cortisol (0-24 h) on Day 1.

Timeframe: following single inhaled doses in mild/moderate asthmatic patients for 48 hours.

Interventions:
  • Drug: GW685698X
  • Drug: GW685698X containing magnesium stearate
    • Enrollment:
    20
    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 furoate
    Collaborators
    Not applicable
    Study date(s)
    February 2007 to April 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Clinically stable persistent mild/moderate asthma within the 4 weeks preceding the screening visit,
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Clinically stable persistent mild/moderate asthma within the 4 weeks preceding the screening visit,
    • screening pre-bronchodilator FEV1 >or=60 % predicted,demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of >or= 12.0% over the max of the three screening measures and an absolute change of >or= 200 mL within 30 minutes following a single 400 mcg salbutamol dose, male or female (of non child bearing potential or meet the contraception criteria),
    • BMI 19-31 kg/m2,
    • Non-smoker,
    • refrains from use of prohibited medication within the specified timeframes Exclusion criteria:
    • Pregnant or nursing females
    • History of life threatening asthma
    • Subjects who are unable to stop taking protocol defined prohibited medication

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wellington, New Zealand, 6035
    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
    2007-09-04

    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

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    Additional information
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