Last updated: 11/04/2018 05:38:26

A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In COPD Patients.

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GSK study ID
B2C110165
See study documents
Clinicaltrials.gov ID
NCT00519376
See results summary
EudraCT ID
2007-001391-37
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 randomised, single-dose, dose ascending, double-blind, placebo controlled, four-way, incomplete block crossover study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled doses of GW642444M with magnesium stearate in COPD patients.
Trial description: This study will involve the use of a new compound, GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. When a medicine is made into a form ready to be given to patients, the active ingredient is often prepared in the form of a salt, and inactive ingredients (excipients) are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In previous studies the study drug has been given as a dry powder in the form of either the ‘H’ salt (with the excipient lactose), or in the form of the ‘M’ salt (with the excipients lactose and cellobiose octaacetate). In this study the ‘M’ salt form of the study drug has been prepared with lactose and a new excipient called magnesium stearate (instead of cellobiose octaacetate). Participants in this study will receive both the ‘H’ salt (GW642444H) and the new ‘M’ salt (GW642444M) containing magnesium stearate. This study will be the first time the new ‘M’ salt form of the study drug will be given to COPD patients.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of participants with any adverse event (AE) or any serious adverse event (SAE) during the Treatment Period

Timeframe: From the first dose of the study medication until the Follow-up Visit (up to Study Day 60)

Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, and white blood cell count at 24 hours post-dose on Day 1 of each treatment period

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration (MCHC) at 24 hours post-dose on Day 1 of each treatment period

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Change from Baseline in reticulocyte and red blood cell (RBC) count at 24 hours post-dose on Day 1 of each treatment period

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Change from Baseline in hematocrit at 24 hours post-dose on Day 1 of each treatment period

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Change from Baseline in mean corpuscle volume (MCV) at 24 hours post-dose on Day 1 of each treatment period

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Change from Baseline in mean corpuscle hemoglobin (MCH) values at 24 hours post-dose on Day 1 of each treatment period

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Change from Baseline in alanine amino transferase (ALT), alkaline phosphatase (ALP), aspartate amino transferase (AST), creatine kinase (CK) and gamma glutamyl transferase (GGT) values at 24 hours post-dose on Day 1 of each treatment period

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Change from Baseline in albumin and total protein at 24 hours post-dose on Day 1 of each treatment period

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Change from Baseline in cholesterol, chloride, potassium, sodium, triglycerides, and urea at 24 hours post-dose on Day 1 of each treatment period

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Change from Baseline in total bilirubin and creatinine at 24 hours post-dose on Day 1 of each treatment period

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Change from Baseline in c-reactive protein at 24 hours post-dose on Day 1 of each treatment period

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) over the post-dose 24 hour (h) period

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Change from Baseline in heart rate over the post-dose 24 hour (h) period

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Change from Baseline in electrocardiographic (ECG) parameters over the post-dose 24 hour (h) period

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Secondary outcomes:

Mean FEV1 over 23 and 24 hours after dosing

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Weighted mean and maximum value (0 - 4 hours) QTc(B) and QTc(F)

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Weighted mean and maximum value (0 - 4 hours) supine heart rate

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Weighted mean and maximum value (0 - 4 hours) of supine systolic and diastolic blood pressure

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Weighted mean and maximum/minimum value (0 - 4 hours) for glucose and potassium

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

AUC(0- t) and up to 1 hour post-dose (AUC[0-1]) of GW642444 and its metabolites GI179710, GW630200, and GSK932009, after a single dose of GW642444

Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)

Cmax of GW642444 and its metabolites GI179710, GW630200, and GSK932009, after a single dose of GW642444

Timeframe: Day 1 of each treatment period (up to Study Day 54)

Tmax of GW642444 and its metabolites GI179710, GW630200, and GSK932009, after a single dose of GW642444

Timeframe: Day 1 of each treatment period (up to Study Day 54)

Interventions:
  • Drug: GW642444M
  • Drug: GW642444H
  • Drug: placebo
    • Enrollment:
    20
    Primary completion date:
    2007-09-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther. 2013;26(2):256-64.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    vilanterol
    Collaborators
    Not applicable
    Study date(s)
    August 2007 to November 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Male or female (of non-childbearing potential) > or = 40 years
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Male or female (of non-childbearing potential) > or = 40 years
    • History of COPD
    • Smoker or ex-smoker
    • Body weight > or = 50 kg with BMI 18-32 kg/m2 Exclusion criteria:
    • History of significant disease
    • Subjects with a primary asthma diagnosis
    • Alpha-1 antitrypsin deficiency as underlying cause of COPD
    • Recent respiratory tract infection
    • Poorly controlled COPD
    • Blood potassium level < 3.5mmol/L
    • Short-term or long tern oxygen therapy
    • Recent participation in another trial
    • History of drug or alcohol abuse
    • Known allergies
    • Recent blood donation
    • ECG abnormalities

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wiesbaden, Hessen, Germany, 65187
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14050
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14057
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Mainz, Rheinland-Pfalz, Germany, 55131
    Status
    Will Be Recruiting
    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
    2007-09-11
    Actual study completion date
    2007-09-11

    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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