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Investigation Of A New Medication (GW642444) In Asthmatic Patients

NCT ID: NCT00354874

Last Updated: 2016-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-06-30

Brief Summary

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This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects.

Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.

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Detailed Description

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Conditions

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Asthma

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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GW642444 50mcg

Group Type EXPERIMENTAL

GW642444

Intervention Type DRUG

drug

GW642444 100mcg

Group Type EXPERIMENTAL

GW642444

Intervention Type DRUG

drug

GW642444 200mcg

Group Type EXPERIMENTAL

GW642444

Intervention Type DRUG

drug

salmeterol 50mcg

Group Type ACTIVE_COMPARATOR

salmeterol 50mcg

Intervention Type DRUG

salmeterol

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Interventions

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GW642444

drug

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

salmeterol 50mcg

salmeterol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).
* Non-smokers for at least 6 months.
* Stable asthma.

Exclusion Criteria

* Abnormal findings on heart monitoring assessment.
* Lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study.
* Currently taking doses of fluticasone propionate over 500mcg/day.
* Unstable asthma medication.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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

Großhansdorf, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Gothenburg, , Sweden

Site Status

Countries

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Germany Sweden

Study Documents

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Document Type: Informed Consent Form

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: Study Protocol

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: Clinical Study Report

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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B2C101762

Identifier Type: -

Identifier Source: org_study_id

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