A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In Asthmatic Patients
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: GW642444H (100mcg) (Drug); placebo (Drug); GW642444M (25, 100 & 400 mcg) (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
Primary outcome: 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).
Secondary outcome: 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).
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
GSK Clinical Trials Call Center, Harrow HA1 3UJ, United Kingdom
GSK Clinical Trials Call Center, Manchester M23 9QZ, United Kingdom
GSK Clinical Trials Call Center, London SE1 1YR, United Kingdom
Additional Information
Starting date: March 2007
Last updated: September 21, 2007
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