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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: placebo; Drug: GW642444H; Drug: GW642444M

Study type: Interventional

Funder types: Industry

Identifiers

NCT00519376

B2C110165

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 5 patient groups

GW642444M 25mcg

Experimental group

Treatment:

Drug: GW642444M

Drug: placebo

GW642444M 50mcg

Experimental group

Treatment:

Drug: GW642444M

GW642444M 100mcg

Experimental group

Treatment:

Drug: GW642444M

Drug: placebo

GW642444H 100mcg

Experimental group

Treatment:

Drug: placebo

Drug: GW642444H

placebo

Experimental group

Treatment:

Drug: placebo