MedDataX Logo

Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients

NCT ID: NCT00358488

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

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 study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.

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 Asthmatic patients GSK159797 Efficacy

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.

GSK159797 (10, 15, and 20mcg)

GSK159797 (10, 15, and 20mcg)

Group Type EXPERIMENTAL

GSK159797 (10, 15, and 20mcg)

Intervention Type DRUG

GSK159797 (10, 15, and 20mcg)

salbutamol

salbutamol

Group Type EXPERIMENTAL

salbutamol

Intervention Type DRUG

salbutamol

salmeterol 50mcg

salmeterol 50mcg

Group Type EXPERIMENTAL

salmeterol 50mcg

Intervention Type DRUG

salmeterol 50mcg

placebo

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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

GSK159797 (10, 15, and 20mcg)

GSK159797 (10, 15, and 20mcg)

Intervention Type DRUG

salbutamol

salbutamol

Intervention Type DRUG

salmeterol 50mcg

salmeterol 50mcg

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Other Intervention Names

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

GSK159797 (10 15 and 20mcg) salbutamol salmeterol 50mcg

Eligibility Criteria

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

Inclusion Criteria

* Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
* Female subjects only using acceptable birth control method
* Non-smokers
* FEV1 between 60 and 90% predicted
* Increase in FEV1 12% or greater and 300mL and greater after salbutamol use

Exclusion Criteria

* Past or present disease conditions
* Normal screening Holter ECG
* Respiratory tract infection within 4 weeks of screening
* History of life threatening asthma
* Previous use of COA
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

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

Wiesbaden, Hesse, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Utrecht, , Netherlands

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Lund, , Sweden

Site Status

GSK Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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

New Zealand Germany Netherlands Russia Sweden United Kingdom

Study Documents

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

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Dataset Specification

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

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.

B2E106359

Identifier Type: -

Identifier Source: org_study_id