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

NCT ID: NCT00519376

Last Updated: 2017-03-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GW642444M 25mcg

Group Type EXPERIMENTAL

GW642444M

Intervention Type DRUG

drug

placebo

Intervention Type DRUG

GW642444M 50mcg

Group Type EXPERIMENTAL

GW642444M

Intervention Type DRUG

drug

GW642444M 100mcg

Group Type EXPERIMENTAL

GW642444M

Intervention Type DRUG

drug

placebo

Intervention Type DRUG

GW642444H 100mcg

Group Type EXPERIMENTAL

GW642444H

Intervention Type DRUG

drug

placebo

Intervention Type DRUG

placebo

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

Interventions

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GW642444M

drug

Intervention Type DRUG

GW642444H

drug

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Wiesbaden, Hesse, Germany

Site Status

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther. 2013 Apr;26(2):256-64. doi: 10.1016/j.pupt.2012.12.001. Epub 2012 Dec 8.

Reference Type BACKGROUND
PMID: 23232038 (View on PubMed)

Study Documents

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Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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B2C110165

Identifier Type: -

Identifier Source: org_study_id

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