NCT00587288

Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma

An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Ception Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma.

Detailed description

Objectives: Primary: To demonstrate the ability of reslizumab to improve asthma control in subjects with active asthma and eosinophilic airway inflammation. Secondary: * To study the ability of reslizumab to reduce induced sputum eosinophil (EOS) counts in subjects with asthma. * To study the ability of reslizumab to reduce the number of eosinophilic clinical asthma exacerbations (CAE) in subjects with asthma. A CAE is defined as a ≥ 20% decrease in forced expiratory volume in 1 second (FEV1; absolute value) from the baseline value or a requirement for emergency treatment of asthma, hospital admission for asthma or treatment with three or more days of oral corticosteroids (OCS) for asthma worsening. * To assess the safety and tolerability of reslizumab in subjects with asthma.

Conditions

• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	Reslizumab
OTHER	Saline

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-01-07
• Last updated: 2016-08-17
• Results posted: 2016-04-26

Locations

30 sites across 2 countries: United States, Canada