Status:
COMPLETED
Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study
Detailed Description
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 Sev...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 9 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2010
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00843193
Start Date
December 9 2008
End Date
July 25 2010
Last Update
December 12 2017
Active Locations (35)
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1
GSK Investigational Site
Medford, Oregon, United States, 97504
2
GSK Investigational Site
Portland, Oregon, United States, 97213
3
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, PA 15213
4
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118