Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma

• Status: Completed
• Trial end date: 2010-07-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Xhance

Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply