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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: placebo; Drug: GW642444M (25, 100 & 400 mcg); Drug: GW642444H (100mcg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00463697

B2C106996

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 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 5 patient groups, including a placebo group

GW642444M 25mcg

Experimental group

Description:

Subject will inhale single dose of GW642444M 25 mcg via a DISKUS device in morning.

Treatment:

Drug: GW642444M (25, 100 & 400 mcg)

GW642444M 100mcg

Experimental group

Description:

Subject will inhale single dose of GW642444M 100 mcg via a DISKUS device in morning.

Treatment:

Drug: GW642444M (25, 100 & 400 mcg)

GW642444M 400mcg

Experimental group

Description:

Subject will inhale single dose of GW642444M 400 mcg via a DISKUS device in morning.

Treatment:

Drug: GW642444M (25, 100 & 400 mcg)

GW642444H 100mcg

Experimental group

Description:

Subject will inhale single dose of GW642444H 100 mcg via a DISKUS device in morning.

Treatment:

Drug: GW642444H (100mcg)

placebo

Placebo Comparator group

Description:

Subject will inhale single dose of Placebo via a DISKUS device in morning.

Treatment:

Drug: placebo