Last updated: 11/07/2018 04:29:34

Safety and Efficacy of GW685698X an inhaled corticosteroid once daily and twice daily for the treatment of asthma

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GSK study ID
112202
See study documents
Clinicaltrials.gov ID
NCT00766090
See results summary
EudraCT ID
2008-005309-20
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 Multi-Centre, Randomized, Double Blind Cross-over study to assess the non-inferiority of GW685698X 200mcg Once Daily and 100mcg Twice Daily in Adult and Adolescent Patients with Asthma
Trial description: The purpose of this study is to compare once and twice daily GW685698 in asthma
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Trough forced expiratory volume in one second (FEV1) at Day 28 of the relevant treatment period

Timeframe: Day 28 of the relevant treatment period (up to Study Day 112)

Secondary outcomes:

Number of participants with any adverse event (AE) and any serious adverse event (SAE) throughout the three 28-day treatment periods

Timeframe: From the first dose of the study medication up to Week 16/Early Withdrawal

24-hour urinary cortisol excretion at Day 28 of the relevant treatment period

Timeframe: Day 28 of the relevant treatment period (up to Study Day 112)

Number of participants with evidence of oropharyngeal candidiasis at Day 0 and Day 28 of the relevant treatment period

Timeframe: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)

Systolic and diastolic blood pressure at Day 0 and Day 28 of the relevant treatment period

Timeframe: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)

Heart rate at Day 0 and Day 28 of the relevant treatment period

Timeframe: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)

Number of participants who withdrew due to worsening of asthma during the three treatment periods

Timeframe: From the first dose of the study medication up to Week 16/Early Withdrawal

Interventions:
  • Drug: GW685698X
    • Enrollment:
    190
    Primary completion date:
    2009-13-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Woodcock A, Bleecker ER, Busse WW, Lötvall J, Snowise NG, Frith L, Jacques L, Haumann B, Bateman ED. Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma. [Respir Res]. 2011;12:160.
    Medical condition
    Asthma
    Product
    fluticasone furoate, fluticasone propionate
    Collaborators
    Not applicable
    Study date(s)
    October 2008 to March 2009
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Clinical diagnosis of Asthma
    • Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2
    • History of life threatening asthma
    • Respiratory Infection or oropharyngeal candidiasis
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Clinical diagnosis of Asthma -Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol -FEV1 between 40-85% predicted -Currently on short acting beta2 agonist therapy
    Exclusion criteria:
    • History of life threatening asthma -Respiratory Infection or oropharyngeal candidiasis -Asthma exacerbation -Uncontrolled disease or clinical abnormality -Allergies -Taking another Investigational medications or other prohibited medications

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Long Beach, California, United States, 90806
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cocoa, Florida, United States, 32927
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tallahassee, Florida, United States, 32308
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbia, Missouri, United States, 65203
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Waco, Texas, United States, 76712
    Status
    Study Complete
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    Showing 1 - 6 of 16 Results

    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
    2009-13-03
    Actual study completion date
    2009-13-03

    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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