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

Phase 1

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: GW642444M (25, 100 & 400 mcg); Drug: GW642444H (100mcg); Drug: placebo

• Registration Number: NCT00463697
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-02
• Study First Submitted: 2007-04-18
• Study First Submitted QC: 2007-04-18
• Study First Posted: 2007-04-20
• Primary Completion: 2007-08-04
• Study Completion: 2007-08-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GW642444M 100mcg	GW642444M (25, 100 & 400 mcg)	Subject will inhale single dose of GW642444M 100 mcg via a DISKUS device in morning.
GW642444M 25mcg	GW642444M (25, 100 & 400 mcg)	Subject will inhale single dose of GW642444M 25 mcg via a DISKUS device in morning.
GW642444M 400mcg	GW642444M (25, 100 & 400 mcg)	Subject will inhale single dose of GW642444M 400 mcg via a DISKUS device in morning.
GW642444H 100mcg	GW642444H (100mcg)	Subject will inhale single dose of GW642444H 100 mcg via a DISKUS device in morning.
placebo	placebo	Subject will inhale single dose of Placebo via a DISKUS device in morning.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Manchester, United Kingdom