MedDataX Logo

Study to Assess GW642444 in Asthma Patients

NCT ID: NCT00381667

Last Updated: 2016-10-28

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a study of GW642444M, a long-acting beta 2 specific agonist. This study will examine GW642444M via the inhaled route and will assess the efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of a single administration of three inhaled doses (25, 100 and 400 µg) of GW642444M in persistent asthmatics. This study will be a single-centre, placebo-controlled, dose-ascending, five-way crossover in 30 asthmatic patients.

Key assessments: efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics will be assessed by measurement of FEV1, blood pressure, pulse rate, 12-lead ECGs, clinical laboratory safety tests, collection of adverse events and blood samples.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

safety GW642444M Single Dose pharmacodynamics pharmacokinetics GW642444H tolerability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GW642444M 12.5

Group Type EXPERIMENTAL

GW642444M

Intervention Type DRUG

M salt

GW642444M 100mcg

Group Type EXPERIMENTAL

GW642444M

Intervention Type DRUG

M salt

GW642444M 400mcg

Group Type EXPERIMENTAL

GW642444M

Intervention Type DRUG

M salt

GW642444H 100mcg

Group Type EXPERIMENTAL

GW642444H

Intervention Type DRUG

H salt

Placebo

Group Type EXPERIMENTAL

placebo

Intervention Type OTHER

placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GW642444M

M salt

Intervention Type DRUG

GW642444H

H salt

Intervention Type DRUG

placebo

placebo

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GW642444

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects with a documented history of persistent asthma, with the exclusion of other significant pulmonary diseases
* Female subjects of non-child bearing potential (i.e. post-menopausal or surgically sterile)
* Subjects who are current non-smokers, who have not used any inhaled tobacco products (snuff is permitted) in the 12 month period preceding the screening visit and who have a pack history of less than 10 pack years.
* Subjects with clinically stable persistent asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 between 60 and 90% predicted (having abstained from bronchodilators for the required period). Predicted values are based on the ECCS 1993 normal ranges
* During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of greater than 12.0% over baseline and an absolute change of greater than 300 mL within 30 minutes following a single 400 mcg salbutamol dose.
* Subjects who are currently taking ICS at a total daily dose of 200 to 500 mcg of FP or equivalent ICS

Exclusion Criteria

* Subjects who have a past or present disease, which as judged by the Investigator and the Medical Monitor, which may affect the safety of the subject or outcome of this study
* A screening Holter ECG tracing that reveals clinically concerning arrhythmias (including, but not limited to, ventricular ectopic runs of 4 beats, R on T phenomena, bigeminy, trigeminy).
* A mean QTc(B) value at screening \>430 msec (male) / \>450 msec (female) or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave).
* Any adverse reaction including immediate or delayed hypersensitivity to any ß2 agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of GW642444 inhalation powder (e.g., lactose or COA).
* Subjects weighing \< 50 kg
* Subjects who have participated in any GSK study involving administration of COA.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Clayton, Victoria, Australia

Site Status

GSK Investigational Site

Wellington, , New Zealand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia New Zealand

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Dataset Specification

View Document

Document Type: Study Protocol

View Document

Related Links

Access external resources that provide additional context or updates about the study.

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

Review additional registry numbers or institutional identifiers associated with this trial.

B2C104604

Identifier Type: -

Identifier Source: org_study_id