NCT02452190

Trial name or title	A 52‐week double‐blind, placebo‐controlled, parallel‐group efficacy and safety study of reslizumab 110 mg fixed, subcutaneous dosing in patients with uncontrolled asthma and elevated blood eosinophils
Methods	Double‐blind, placebo‐controlled, parallel‐group study
Participants	469 participants with unstable asthma Inclusion criteria Male or female, ≥ 12 years, with a diagnosis of asthma FEV1 reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol Required an inhaled corticosteroid Required an additional asthma controller medication besides inhaled corticosteroids History of asthma exacerbation
Interventions	Reslizumab will be administered subcutaneously in a dose of 110 mg every 4 weeks versus placebo
Outcomes	The primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard‐of‐care asthma therapy. Primary outcome measures Frequency of clinical asthma exacerbations (time frame: 52 weeks) Spirometry Secondary outcome measures Change in FEV1 (time frame: baseline, week 52) Change in Asthma Quality of Life Questionnaire (time frame: 52 weeks) Change in Asthma Control Questionnaire (time frame: baseline, week 52) Percentage of participants with adverse events (time frame: 52 weeks) Change in total asthma symptom scores (time frame: baseline, 52 weeks) Asthma control days (time frame: 52 weeks) Change in St. George's Respiratory Questionnaire (time frame: baseline, week 32) Time to first clinical asthma exacerbation (time frame: 52 weeks) Frequency of exacerbations requiring hospitalisation or emergency department visits (time frame: 52 weeks) Frequency of moderate exacerbations (time frame: 52 weeks)
Starting date	September 2015
Contact information	Study Director: Teva Medical Expert, MD
Notes	Estimated study completion date: January 2018 Responsible party: Teva Branded Pharmaceutical Products, R&D Inc. International multicentre study with 200 centres