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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00519376
First received: August 21, 2007
Last updated: May 31, 2012
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Drug: GW642444M
Drug: GW642444H
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 12-lead ECGs [ Time Frame: At screening, at follow-up and over a 24h period in each of the 4 treatment periods ] [ Designated as safety issue: No ]
  • 3-lead 24 h holter monitoring [ Time Frame: At screening, at follow-up and over a 24h period in each of the 4 treatment periods ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: At screening, at follow-up and over a 24h period in each of the 4 treatment periods ] [ Designated as safety issue: No ]
  • Pulse rate [ Time Frame: At screening, at follow-up and over a 24h period in each of the 4 treatment periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Airways relaxation assessed by lung function tests (FEV1) [ Time Frame: At screening, at follow-up and over a 24h period in each of the 4 treatment periods ] [ Designated as safety issue: No ]
  • Amount of medicine in the body measured by medicine in blood samples [ Time Frame: Over a 24 hour period in each of the 4 treatment periods ] [ Designated as safety issue: No ]
  • Potassium blood levels [ Time Frame: Over a 24 hour period in each of the 4 treatment periods ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GW642444M 25mcg Drug: GW642444M
drug
Drug: placebo
Experimental: GW642444M 50mcg Drug: GW642444M
drug
Experimental: GW642444M 100mcg Drug: GW642444M
drug
Drug: placebo
Experimental: GW642444H 100mcg Drug: GW642444H
drug
Drug: placebo
Experimental: placebo Drug: placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519376

Locations
Germany
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65187
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Berlin, Germany, 14050
GSK Investigational Site
Berlin, Germany, 14057
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00519376     History of Changes
Other Study ID Numbers: B2C110165
Study First Received: August 21, 2007
Last Updated: May 31, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
pharmacodynamics,
Chronic Obstructive Pulmonary Disease (COPD)
safety,
COPD patients
 pharmacokinetics,
tolerability,
GW642444,

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on May 16, 2013