Last updated: 11/07/2018 05:52:30

Efficacy and Safety Study in Subjects with Asthma

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GSK study ID
113310
See study documents
Clinicaltrials.gov ID
NCT00980200
See results summary
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 multi-center, randomized, double-blind, placebo-controlled, five period cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of GW642444 administered via a novel dry powder inhaler (NDPI) in subjects ≥18 years of age with persistent asthma
Trial description: The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of the novel long acting beta agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in trough (pre-bronchodilator and pre-dose) FEV1 on Day 7 of the treatment period

Timeframe: Baseline and Day 7 of the treatment period (up to Study Day 63)

Secondary outcomes:

Change from Baseline in weighted mean 24-hour FEV1 on Day 7 of the treatment period

Timeframe: Baseline and Day 7 of the treatment period (up to Study Day 63)

Interventions:
  • Drug: Dose 4 QD
  • Drug: Dose 3 QD
  • Drug: placebo
  • Drug: Dose 2 QD
  • Drug: Dose 1 BD
    • Enrollment:
    75
    Primary completion date:
    2010-04-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Sterling R, Lim J, Frith L, Snowise NG, Jacques L, Haumann B. Efficacy and optimal dosing interval of the long-acting beta2 agonist, vilanterol, in persistent asthma: a randomised trial. [Respir Med]. 2012;106(8):1110-1115.
    Medical condition
    Asthma
    Product
    vilanterol
    Collaborators
    Not applicable
    Study date(s)
    September 2009 to January 2010
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Outpatient
    • ≥18 years of age at Visit 1
    • History of Life-Threatening Asthma
    • No use of systemic corticosteroids for any indication within 8 weeks prior to Visit
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Outpatient
    • ≥18 years of age at Visit 1
    • Male or Eligible Female
    • Diagnosis of asthma at least 12 weeks prior to Visit 1
    • Disease reversibility
    • Current anti-asthma therapy
    • Appropriately signed and dated informed consent has been obtained
    • Able to comply with all the study requirements
    Exclusion criteria:
    • History of Life-Threatening Asthma
    • No use of systemic corticosteroids for any indication within 8 weeks prior to Visit
    • No concurrent diseases/abnormalities that would put the safety of the subject at risk through study participation
    • Drug Allergy to β2 agonist or sympathomimetic drugs, or known or suspected sensitivity to lactose or magnesium stearate
    • History of severe milk protein allergy
    • Non-compliance with study medication and other study-related requirements
    • No use of inhaled tobacco products within the past three months or historical use of 10 pack years or more
    • Administration of prohibited medications and non-drug therapies and corresponding timeframes as outlined in the protocol

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Orangeburg, South Carolina, United States, 29118
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bethesda, Maryland, United States, 20814
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Medford, Oregon, United States, 97504
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cypress, California, United States, 90630
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Huntington Beach, California, United States, 92647
    Status
    Study Complete
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    Showing 1 - 6 of 9 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
    2010-04-01
    Actual study completion date
    2010-04-01

    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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