Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
GW642444,, magnesium stearate,, asthmatic patients
Brief 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.
Interventions
DRUGGW642444H (100mcg)
H salt
DRUGplacebo
placebo
DRUGGW642444M (25, 100 & 400 mcg)
M salt
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks). |
Secondary
| Measure | Time frame |
|---|---|
| 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). | Measurements made over 24 hours on 5 occasions (1-2 weeks apart). |
Countries
United Kingdom
Outcome results
None listed