Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT00843193

Run by

GlaxoSmithKline

People needed

198

Starts

2008-12-09

Expected to finish

2010-07-25

Last updated by the study team

2017-12-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• GSK Investigational Site — Medford, Oregon, United States
• GSK Investigational Site — Portland, Oregon, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Orangeburg, South Carolina, United States
• GSK Investigational Site — Boerne, Texas, United States
• GSK Investigational Site — Madison, Wisconsin, United States
• GSK Investigational Site — Lille, France
• GSK Investigational Site — Marseille, France
• GSK Investigational Site — Montpellier, France
• GSK Investigational Site — Nantes, France
• GSK Investigational Site — Saint-Pierre, France
• GSK Investigational Site — Strasbourg, France
• GSK Investigational Site — Tarbes, France
• GSK Investigational Site — Frankfurt am Main, Hesse, Germany
• GSK Investigational Site — Gelnhausen, Hesse, Germany
• GSK Investigational Site — Magdeburg, Saxony-Anhalt, Germany
• GSK Investigational Site — Eindhoven, Netherlands
• GSK Investigational Site — Heerlen, Netherlands
• GSK Investigational Site — Hoorn, Netherlands
• GSK Investigational Site — Elverum, Norway
• GSK Investigational Site — Trondheim, Norway
• GSK Investigational Site — Bialystok, Poland
• GSK Investigational Site — Gidle, Poland
• GSK Investigational Site — Krakow, Poland
• GSK Investigational Site — Lodz, Poland

Full record on ClinicalTrials.gov

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