A Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Study ID
NCT01287039
Phase
PHASE3
Status
Completed

Conditions

  • Eosinophilic Asthma

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Reslizumab — DRUG
    Patients were administered intravenously over 15 to 30 minutes reslizumab at a dosage of 3.0 mg/kg at baseline and once every 4 weeks relative to baseline over 48 weeks for a total of 13 doses.
  • Placebo — DRUG
    Matching placebo (20 mM sodium acetate, 7% sucrose), administered intravenously (iv) once every 4 weeks over 52 weeks, for a total of 13 doses administered. Each patient received a specific volume of placebo to match the volume of reslizumab on the basis of the patient's body weight.

Study Details

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in patients with eosinophilic asthma.

Key Dates

Start date
Apr 30, 2011
Status verified
Nov 2021
Primary completion
Dec 31, 2013
Completion
Mar 31, 2014

Study Design

Enrollment
489 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
  • Experimental: Reslizumab 3.0 mg/kg
    Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.

Primary Outcome Measure

Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment [ Time Frame: Day 1 to Week 52 ]

Locations (26)

FacilityCityStateZIPSite coordinators
Teva Investigational Site 58ScottsdaleArizona--
Teva Investigational Site 61Los AngelesCalifornia--
Teva Investigational Site 37OrangeCalifornia--
Teva Investigational Site 56San DiegoCalifornia--
Teva Investigational Site 34Colorado SpringsColorado--
Teva Investigational Site 52DeBaryFlorida--
Teva Investigational Site 55MiamiFlorida--
Teva Investigational Site 18ValricoFlorida--
Teva Investigational Site 49LexingtonKentucky--
Teva Investigational Site 65LouisvilleKentucky--
Teva Investigational Site 51BostonMassachusetts--
Teva Investigational Site 74St LouisMissouri--
Teva Investigational Site 35MissoulaMontana--
Teva Investigational Site 64Boys TownNebraska--
Teva Investigational Site 68RochesterNew York--
Teva Investigational Site 60The BronxNew York--
Teva Investigational Site 30Winston-SalemNorth Carolina--
Teva Investigational Site 31CincinnatiOhio--
Teva Investigational Site 62ColumbusOhio--
Teva Investigational Site 50Oklahoma CityOklahoma--
Teva Investigational Site 66AltoonaPennsylvania--
Teva Investigational Site 32NashvilleTennessee--
Teva Investigational Site 63BoerneTexas--
Teva Investigational Site 72HoustonTexas--
Teva Investigational Site 38RichmondVirginia--
Teva Investigational Site 33MadisonWisconsin--

Find similar trials in Scottsdale, AZ

By research site
Teva Investigational· Scottsdale, AZTeva Investigational· Los Angeles, CATeva Investigational· Orange, CATeva Investigational· San Diego, CATeva Investigational· Colorado Springs, COTeva Investigational· DeBary, FL

Related Studies