Last updated: 11/04/2018 08:19:21

A Study To Assess Single Dosage Strength Of GW685698/GW642444 Chronic Obstructive Pulmonary Disease (COPD)

GSK study ID
HZC111348
Clinicaltrials.gov ID
EudraCT ID
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: Study HZC111348, a repeat-dose study of GW685698/GW642444 Inhalation Powder versus Placebo in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The purpose of this study is to assess the safety and efficacy of a single dosage strength of GW685698/GW642444 in subjects with Chronic Obstructive Pulmonary Disease (COPD).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Change from Baseline in weighted mean heart rate 0-4 hours post-dose at the end of the 28-day treatment period

Timeframe: Baseline to Day 28

Number of participants with any adverse event (AE) and any serious adverse event (SAE) throughout the study

Timeframe: From Baseline (Day 1) until Follow-up (up to Study Day 37)

Secondary outcomes:

Mean change from Baseline in clinic visit trough forced expiratory volume in one second (FEV1) on Days 2, 15, and 29

Timeframe: Baseline; Day 2, Day 15, and Day 29

Mean change from Baseline (pre-dose on Day 1) in weighted mean FEV1 (0-4 hours post-dose) on Days 1 and 28

Timeframe: Baseline (pre-dose on Day 1); Day 1 and Day 28

Interventions:
  • Drug: GW685698/GW642444
  • Enrollment:
    60
    Primary completion date:
    2009-25-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Lötvall J, Bakke P, Bjermer L, Steinshamn S, Crim C, Sanford L, Scott-Wilson C, Haumann B. Efficacy and safety of 4 weeks' treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial. [BMJ Open]. 2012;2(1):e000370.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone furoate, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    August 2008 to February 2009
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    40 - 80 years
    Accepts healthy volunteers
    No
    • Subjects eligible for enrollment in the study must meet all of the following criteria:
    • 1. Informed consent: Subjects must give their signed written informed consent to participate.
    • Subjects meeting any of the following criteria must not be enrolled in the study:
    • 1. Pregnancy: Women who are pregnant or lactating

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    STOCKHOLM, Sweden, SE-118 83
    Status
    Study Complete
    Location
    GSK Investigational Site
    Trondheim, Norway, 7030
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sandvika, Norway, 1337
    Status
    Study Complete
    Location
    GSK Investigational Site
    LULEĂ…, Sweden, SE-971 89
    Status
    Study Complete
    Location
    GSK Investigational Site
    LUND, Sweden, SE-221 85
    Status
    Study Complete
    Location
    GSK Investigational Site
    Fredrikstad, Norway, 1606
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English

    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
    2009-25-02
    Actual study completion date
    2009-25-02

    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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