A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In Asthmatic Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive Asthma |
Drug: GW642444H (100mcg) Drug: placebo Drug: GW642444M (25, 100 & 400 mcg) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
- 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). [ Time Frame: Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks). ] [ Designated as safety issue: No ]
- 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). [ Time Frame: Measurements made over 24 hours on 5 occasions (1-2 weeks apart). ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | April 2007 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: GW642444M 25mcg |
Drug: GW642444M (25, 100 & 400 mcg)
M salt
Other Names:
|
| Experimental: GW642444M 100mcg |
Drug: GW642444M (25, 100 & 400 mcg)
M salt
Other Names:
|
| Experimental: GW642444M 400mcg |
Drug: GW642444M (25, 100 & 400 mcg)
M salt
Other Names:
|
| Experimental: GW642444H 100mcg |
Drug: GW642444H (100mcg)
H salt
|
| Placebo Comparator: placebo |
Drug: placebo
placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United Kingdom | |
| GSK Investigational Site | |
| Harrow, Middlesex, United Kingdom, HA1 3UJ | |
| GSK Investigational Site | |
| London, United Kingdom, SE1 1YR | |
| GSK Investigational Site | |
| Manchester, United Kingdom, M23 9QZ | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00463697 History of Changes |
| Other Study ID Numbers: | B2C106996 |
| Study First Received: | April 18, 2007 |
| Last Updated: | May 31, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by GlaxoSmithKline:
|
GW642444, magnesium stearate, asthmatic patients |
Additional relevant MeSH terms:
|
Asthma Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Bronchial Diseases Respiratory Tract Diseases |
Lung Diseases, Obstructive Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013