Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: INTRAVENOUS GSK679586; Drug: FLUTICASONE PROPIONATE; Drug: INTRAVENOUS PLACEBO

Study type: Interventional

Funder types: Industry

Identifiers

NCT00843193

106870

Details and patient eligibility

About

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

Full 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 Severe Asthma

Enrollment: 198 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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198 participants in 2 patient groups, including a placebo group

GSK679586

Experimental group

Description:

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

Treatment:

Drug: INTRAVENOUS GSK679586

Drug: FLUTICASONE PROPIONATE

PLACEBO

Placebo Comparator group

Description:

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

Treatment:

Drug: FLUTICASONE PROPIONATE

Drug: INTRAVENOUS PLACEBO