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Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma

NCT ID: NCT00843193

Last Updated: 2017-12-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-09

Study Completion Date

2010-07-25

Brief Summary

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Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study

Detailed Description

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A Multi-Centre, Multi-country, Randomized, Double-Blind (Subject, Investigator), Placebo-Controlled, Repeat-Dose study to evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients with Severe Asthma

Conditions

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Asthma

Keywords

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Asthma Asthma control questionnaire

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GSK679586

Subjects will receive three, once monthly intravenous administration of 10 mg/kg of GSK679586, according to randomization

Group Type EXPERIMENTAL

INTRAVENOUS GSK679586

Intervention Type DRUG

GSK679586 will be provided as a clear or colorless to pale yellow liquid with the unit dose strength of 10mg/kg and will be infused over an hour. The infusion will be delivered by a programmable infusion pump

FLUTICASONE PROPIONATE

Intervention Type DRUG

Subjects will be supplied fluticasone propionate at Screening, Run-in and when needed during the study. Subjects will be up-titrated to 1000 μg/day and those who were already taking greater than equal to 1000 μg/day fluticasone propionate or equivalent prior to the study will remain on their pre-study dose.

PLACEBO

Subjects will receive three, once monthly intravenous administration of saline, according to randomization

Group Type PLACEBO_COMPARATOR

INTRAVENOUS PLACEBO

Intervention Type DRUG

Clear or colorless 0.9% sodium chloride saline solution will be infused over an hour. The infusion will be delivered by a programmable infusion pump

FLUTICASONE PROPIONATE

Intervention Type DRUG

Subjects will be supplied fluticasone propionate at Screening, Run-in and when needed during the study. Subjects will be up-titrated to 1000 μg/day and those who were already taking greater than equal to 1000 μg/day fluticasone propionate or equivalent prior to the study will remain on their pre-study dose.

Interventions

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INTRAVENOUS GSK679586

GSK679586 will be provided as a clear or colorless to pale yellow liquid with the unit dose strength of 10mg/kg and will be infused over an hour. The infusion will be delivered by a programmable infusion pump

Intervention Type DRUG

INTRAVENOUS PLACEBO

Clear or colorless 0.9% sodium chloride saline solution will be infused over an hour. The infusion will be delivered by a programmable infusion pump

Intervention Type DRUG

FLUTICASONE PROPIONATE

Subjects will be supplied fluticasone propionate at Screening, Run-in and when needed during the study. Subjects will be up-titrated to 1000 μg/day and those who were already taking greater than equal to 1000 μg/day fluticasone propionate or equivalent prior to the study will remain on their pre-study dose.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* history of asthma for ≥ 6 months
* taking inhaled corticosteroids
* non-smoking
* Baseline (pre-bronchodilator) FEV1 35-80% predicted at screening.
* Reversible airways disease as indicated by an increase of FEV1 ≥12% from baseline after nebulised salbutamol or albuterol.
* symptomatic according to the ACQ-7

Exclusion Criteria

* Unstable severe asthma
* Recent respiratory illness
* Presence of other respiratory disease or chronic pulmonary condition other than asthma
* Treatment with omalizumab within 4 months of study
* Recent gastrointestinal or respiratory parasitic infestation
* History of severe allergy to food or drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

Medford, Oregon, United States

Site Status

GSK Investigational Site

Portland, Oregon, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Orangeburg, South Carolina, United States

Site Status

GSK Investigational Site

Boerne, Texas, United States

Site Status

GSK Investigational Site

Madison, Wisconsin, United States

Site Status

GSK Investigational Site

Lille, , France

Site Status

GSK Investigational Site

Marseille, , France

Site Status

GSK Investigational Site

Montpellier, , France

Site Status

GSK Investigational Site

Nantes, , France

Site Status

GSK Investigational Site

Saint-Pierre, , France

Site Status

GSK Investigational Site

Strasbourg, , France

Site Status

GSK Investigational Site

Tarbes, , France

Site Status

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

Site Status

GSK Investigational Site

Gelnhausen, Hesse, Germany

Site Status

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

Site Status

GSK Investigational Site

Eindhoven, , Netherlands

Site Status

GSK Investigational Site

Heerlen, , Netherlands

Site Status

GSK Investigational Site

Hoorn, , Netherlands

Site Status

GSK Investigational Site

Elverum, , Norway

Site Status

GSK Investigational Site

Trondheim, , Norway

Site Status

GSK Investigational Site

Bialystok, , Poland

Site Status

GSK Investigational Site

Gidle, , Poland

Site Status

GSK Investigational Site

Krakow, , Poland

Site Status

GSK Investigational Site

Lodz, , Poland

Site Status

GSK Investigational Site

Warsaw, , Poland

Site Status

GSK Investigational Site

Cape Town, Gauteng, South Africa

Site Status

GSK Investigational Site

Bellville, , South Africa

Site Status

GSK Investigational Site

Bloemfontein, , South Africa

Site Status

GSK Investigational Site

Mowbray, , South Africa

Site Status

GSK Investigational Site

Southampton, Hampshire, United Kingdom

Site Status

GSK Investigational Site

Guildford, Surrey, United Kingdom

Site Status

GSK Investigational Site

Belfast, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

Nottingham, , United Kingdom

Site Status

Countries

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United States France Germany Netherlands Norway Poland South Africa United Kingdom

References

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Anderson WH, Koshy BT, Huang L, Mosteller M, Stinnett SW, Condreay LD, Ortega H. Genetic analysis of asthma exacerbations. Ann Allergy Asthma Immunol. 2013 Jun;110(6):416-422.e2. doi: 10.1016/j.anai.2013.04.002.

Reference Type DERIVED
PMID: 23706709 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Informed Consent Form

View Document

Document Type: Dataset Specification

View Document

Document Type: Individual Participant Data Set

View Document

Related Links

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http://www.ginasthma.com/

Ginasthma.com is a website of the Global Initiative for Asthma. This study uses the GINA guidance, 2007 for diagnosis asthma patients who are eligible for entry this study.

Other Identifiers

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106870

Identifier Type: -

Identifier Source: org_study_id