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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00463697
First received: April 18, 2007
Last updated: May 31, 2012
Last verified: February 2011
  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 with another ingredient called a salt to help make it stable, and inactive ingredients 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 containing either the "H" salt (with the inactive ingredient lactose), or containing the "M" salt (with the inactive ingredients lactose and cellobiose octaacetate). The "M" salt form of the study drug has been altered to contain lactose and a new inactive ingredient 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 asthmatic patients.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Asthma
Drug: GW642444H (100mcg)
Drug: placebo
Drug: GW642444M (25, 100 & 400 mcg)
Phase 1

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 Randomized, Single-dose, Dose-ascending, Double Blind, Placebo-controlled, 5-way Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M With Magnesium Stearate in Asthmatic Patients

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • General safety and tolerability of the new formulation of GW642444 as measured by ECG, blood pressure, pulse rate and blood and urine tests. Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks). [ Time Frame: Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Airways relaxation assessed by lung function tests. Effect of study medicine on the body and amount of medicine in the body measured by potassium, glucose and medicine in blood samples. Measurements made over 24 hours on 5 occasions (1-2 weeks apart). [ Time Frame: Measurements made over 24 hours on 5 occasions (1-2 weeks apart). ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GW642444M 25mcg Drug: GW642444M (25, 100 & 400 mcg)
M salt
Other Names:
  • placebo
  • GW642444M (25
  • 100 & 400 mcg)
  • GW642444H (100mcg)
Experimental: GW642444M 100mcg Drug: GW642444M (25, 100 & 400 mcg)
M salt
Other Names:
  • placebo
  • GW642444M (25
  • 100 & 400 mcg)
  • GW642444H (100mcg)
Experimental: GW642444M 400mcg Drug: GW642444M (25, 100 & 400 mcg)
M salt
Other Names:
  • placebo
  • GW642444M (25
  • 100 & 400 mcg)
  • GW642444H (100mcg)
Experimental: GW642444H 100mcg Drug: GW642444H (100mcg)
H salt
Placebo Comparator: placebo Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • male or female (of non-childbearing potential) between 18 - 70 years
  • History of stable mild to moderate asthma
  • non - smokers
  • currently taking daily doses of inhaled fluticasone propionate 200 - 500 mcg (or equivalent)
  • body weight >50 kg with BMI 19-29.9 kg/m2
  • normal ECG assessment

Exclusion criteria:

  • history of significant disease
  • history of life threatening asthma
  • recent respiratory tract infection
  • recent change of asthma medication
  • treatment with high dose inhaled corticosteroids or oral corticosteroids
  • recent participation in another trial
  • history of drug or alcohol abuse
  • known allergies (excluding asthma)
  • recent blood donation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463697

Locations
United Kingdom
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
GSK Investigational Site
London, United Kingdom, SE1 1YR
GSK Investigational Site
Manchester, United Kingdom, M23 9QZ
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: NCT00463697     History of Changes
Other Study ID Numbers: B2C106996
Study First Received: April 18, 2007
Last Updated: May 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
GW642444,
magnesium stearate,
asthmatic patients

Additional relevant MeSH terms:
Asthma
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014