Last updated: 11/04/2018 05:35:09

Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients

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GSK study ID
B2C106093
See study documents
Clinicaltrials.gov ID
NCT00347139
See results summary
EudraCT ID
2005-004419-31
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: Multi-centre, randomised, double-blind, placebo-controlled, four-way incomplete block crossover study, to examine efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat administration of three inhaled doses (25, 100 and 400 mcg once daily) of GW642444
Trial description: In order to obtain information on a wider range of doses of GW642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar manner to a study that has already been completed (study number B2C101762) which examined repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data from study B2C101762 and will provide confidence (or not) that the desired bronchodilation can be achieved and maintained without undesirable side effects.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

Mean change from Baseline (pre-dose on Day 1) in the mean of 23 and 24 hour (h) visit (pre-bronchodilator and pre-dose) trough FEV1 after repeat dosing over 14 days

Timeframe: From Baseline (pre-dose on Day 1) and up to 14 days

Secondary outcomes:

Mean change from Baseline (pre-dose on Day 1) in weighted mean clinic FEV1 on Day 1 and Day 14

Timeframe: From Baseline (pre-dose on Day 1) and at 0-2 h, 0-4, and 0-24 h Days 1 and 14

Mean change from Baseline (pre-dose on Day 1) in morning (AM) Peak expiratory flow rate (PEFR) from electronic flow meter over Days 2-15

Timeframe: Baseline (pre-dose on Day 1) and up to 15 days

Mean change from Baseline (pre-dose on Day 1) in the evening (PM) PEFR from electronic flow meter over Days 1-14

Timeframe: Baseline (pre-dose on Day 1) and up to 14 days

Mean change from Baseline (pre-dose on Day 1) in AM FEV1 from electronic flow meter over Days 2-15

Timeframe: Baseline (pre-dose on Day 1), Day 2, and Day 15

Mean change from Baseline (pre-dose on Day 1) in PM FEV1 from electronic flow meter over 14 days

Timeframe: Baseline (pre-dose on Day 1) and up to Day 14

Change in AM PEFR from Pre-AM Dose to Post-AM Dose at Day1, 7, and 14

Timeframe: Day 1, 7, and 14

Change in PM PEFR from Pre-PM Dose to Post-PM Dose at Day1, 7, and 14

Timeframe: Day 1, 7, and 14

Interventions:
  • Drug: GW642444 (25, 100 & 400 mcg/day)
  • Drug: Salmeterol 50mcg
    • Enrollment:
    55
    Primary completion date:
    2007-10-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    salmeterol, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    May 2006 to January 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 70 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Subjects with a documented history of persistent asthma.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Subjects with a documented history of persistent asthma.
    • Current non-smokers.
    • Clinically stable persistent asthma FEV1 between 60 and 90% of predicted values.
    • Inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone or equivalent. Exclusion criteria:
    • Subjects with significant past or present disease which which may affect their safety.
    • Upper or lower respiratory tract infection within 4 weeks of screening.
    • History of life threatening asthma, or asthma requiring treatment with oral corticosteroids within 3 months of study.
    • Patients taking doses of inhaled corticosteroid >500mcg/day and patients who have changed therapy within 8 weeks of the study.
    • Patients weighing less than 50kg.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wellington, New Zealand, 6035
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, SE5 9RJ
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Grosshansdorf, Schleswig-Holstein, Germany, 22927
    Status
    Study Complete
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    Location
    GSK Investigational Site
    GÖTEBORG, Sweden, SE-413 45
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Moscow, Russia, 105 077
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    STOCKHOLM, Sweden, SE-141 86
    Status
    Terminated/Withdrawn
    Contact us
    Showing 1 - 6 of 7 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
    2007-10-01
    Actual study completion date
    2007-10-01

    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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