Last updated: 11/04/2018 05:39:56

Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients

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GSK study ID
B2E106359
See study documents
Clinicaltrials.gov ID
NCT00358488
See results summary
EudraCT ID
2005-005329-68
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-enter, randomized, 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 (10, 15, and 20 mcg) of GSK159797
Trial description: This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Mean change from Baseline in the mean of the 23 and 24 hour clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in 1 second (FEV1) after repeat dosing for 14 days.

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

Secondary outcomes:

Mean change from Baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 after a single dose (Day 1)

Timeframe: Baseline (pre-dose on Day 1) and 23 and 24 hour post-dose on Day 1

Mean change from Baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Day 7

Timeframe: Baseline (pre-dose on Day 1) and Day 7

Change from Baseline in weighted mean clinic FEV1 over 0-2 hours, 0-4 hours and 0-24 hours on Day 1 and Day 14

Timeframe: Baseline (pre-dose on Day 1) and 0-2 hours, 0-4 hours and 0-24 hours on Day 1 and Day 14

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

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

Mean change from Baseline in evening (PM PEFR) from electronic flow meter over Days 1-14

Timeframe: Baseline (pre-dose on Day 1) and 12 and 13 hour post-dose on Day 1 to Day 14

Mean change from Baseline in AM FEV1 from electronic flow meter over Days 2-15

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

Mean change from Baseline in PM FEV1 from electronic flow meter over Days 1-14.

Timeframe: Baseline (pre-dose on Day 1) and 12 and 13 hour post-dose on Day 1 to Day 14

Interventions:
  • Drug: GSK159797 (10, 15, and 20mcg)
  • Drug: salbutamol
  • Drug: salmeterol 50mcg
  • Drug: placebo
    • Enrollment:
    54
    Primary completion date:
    2007-24-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    milveterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    April 2006 to January 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female
    Age
    18 - 70 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
    • Female subjects only using acceptable birth control method
    • Non-smokers
    • FEV1 between 60 and 90% predicted
    • Increase in FEV1 12% or greater and 300mL and greater after salbutamol use Exclusion criteria:
    • Past or present disease conditions
    • Normal screening Holter ECG
    • Respiratory tract infection within 4 weeks of screening
    • History of life threatening asthma
    • Previous use of COA

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wiesbaden, Hessen, Germany, 65187
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14057
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Moscow, Russia, 115446
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Manchester, United Kingdom, M23 9LT
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    UTRECHT, Netherlands, 3584 CJ
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    LUND, Sweden, SE-221 85
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-24-01
    Actual study completion date
    2007-24-01

    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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