AzTrials
AzTrials

AsthmaPhase 3NCT02452190

Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils

A Phase 3 study testing Reslizumab in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 226 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Reslizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
468 participants
Where
226 sitesin 21 countries
Study dates
28 Sep 2015to 31 Jan 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Written informed consent is obtained.
  • The participant is male or female, 12 years of age and older, with a diagnosis of asthma.
  • The participant has Forced Expiratory Volume in 1 Second (FEV1) reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol.
  • The participant has required an inhaled corticosteroid.
  • The participant has required an additional asthma controller medication besides inhaled corticosteroids.
  • The participant has a history of asthma exacerbation.
  • The participant must be willing and able to comply with study restrictions, perform requisite procedures and remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.
  • Additional criteria may apply, please contact the investigator for more information

Who cannot join

  • The participant has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient's safety.
  • The participant has another confounding underlying lung disorder
  • The participant has a known hypereosinophilic syndrome.
  • The participant has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
  • The participant is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study.
  • The participant is a current smoker or has a smoking history.
Show all 13Show fewer
  • The participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
  • The participant was previously exposed to reslizumab.
  • The participant has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).
  • The participant has current or suspected drug and alcohol abuse.
  • The participant has an active helminthic parasitic infection or was treated for one within 6 months of screening.
  • The participant has a history of allergic reaction or hypersensitivity to any component of the study drug.
  • Additional criteria may apply, please contact the investigator for more information

Trial locations and contacts

226 sites in 21 countries.

226 sites in 21 countries

United States69 sites

  • Teva Investigational Site 13207

    Abingdon, Virginia, 24210

  • Teva Investigational Site 13765

    Albany, Georgia, 31707

  • Teva Investigational Site 13185

    Arlington, Texas, 76018

  • Teva Investigational Site 13196

    Aventura, Florida, 33180

  • Teva Investigational Site 13215

    Bakersfield, California, 93301

  • Teva Investigational Site 13769

    Belleville, New Jersey, 07109

  • Teva Investigational Site 13242

    Bethlehem, Pennsylvania, 18020

  • Teva Investigational Site 13226

    Biloxi, Mississippi, 39531

  • Teva Investigational Site 13212

    Birmingham, Alabama, 35209

  • Teva Investigational Site 13258

    Boys Town, Nebraska, 68010

  • Teva Investigational Site 13249

    Buford, Georgia, 30518

  • Teva Investigational Site 13181

    Canoga Park, California, 91303

  • Teva Investigational Site 13230

    Chicago, Illinois, 60612

  • Teva Investigational Site 13186

    Cincinnati, Ohio, 45267

  • Teva Investigational Site 13253

    Cleveland, Ohio, 44106

  • Teva Investigational Site 13199

    Corsicana, Texas, 75110

  • Teva Investigational Site 13260

    Dallas, Texas, 75225

  • Teva Investigational Site 13229

    Denver, Colorado, 80206

  • Teva Investigational Site 13209

    East Providence, Rhode Island, ?02914

  • Teva Investigational Site 13259

    Edmond, Oklahoma, 73034

  • Teva Investigational Site 13183

    Fairfax, Virginia, 22030

  • Teva Investigational Site 13257

    Falls Church, Virginia, 22044

  • Teva Investigational Site 13241

    Flagstaff, Arizona, 86001

  • Teva Investigational Site 13256

    Fort Lauderdale, Florida, 33308

  • Teva Investigational Site 13254

    Fresno, California, 93720

  • Teva Investigational Site 13194

    Glendale, Arkansas, 85306

  • Teva Investigational Site 13216

    Huntington Beach, California, 92647

  • Teva Investigational Site 13218

    Jenkintown, Pennsylvania, 19046

  • Teva Investigational Site 13203

    Kissimmee, Florida, 34741

  • Teva Investigational Site 13223

    Knoxville, Tennessee, 37919

  • Teva Investigational Site 13191

    Lafayette, Louisiana, 70503

  • Teva Investigational Site 13763

    Lawrenceville, Georgia, 30045

  • Teva Investigational Site 13225

    Lenexa, Kansas, 66215

  • Teva Investigational Site 13217

    Lincoln, Rhode Island, 02865

  • Teva Investigational Site 13247

    Long Beach, California, 90813

  • Teva Investigational Site 13195

    Medford, Oregon, 97504

  • Teva Investigational Site 13197

    Miami, Florida, 33125

  • Teva Investigational Site 13220

    Miami, Florida, 33155

  • Teva Investigational Site 13243

    Miami, Florida, 33176

  • Teva Investigational Site 13202

    Michigan City, Indiana, 46360

  • Teva Investigational Site 13205

    Napa, California, 94558

  • Teva Investigational Site 13188

    New Hyde Park, New York, 11040

  • Teva Investigational Site 13233

    New Port Richey, Florida, 34653

  • Teva Investigational Site 13232

    New York, New York, 10016

  • Teva Investigational Site 13767

    New York, New York, 11570

  • Teva Investigational Site 13211

    Normal, Illinois, 61761

  • Teva Investigational Site 13200

    North Dartmouth, Massachusetts, 02747

  • Teva Investigational Site 13210

    Ocean City, New Jersey, 07712

  • Teva Investigational Site 13238

    Oklahoma City, Oklahoma, 73112

  • Teva Investigational Site 13201

    Orlando, Florida, 32811

  • Teva Investigational Site 13250

    Orlando, Florida, 32819

  • Teva Investigational Site 13222

    Owensboro, Kentucky, 42301

  • Teva Investigational Site 13246

    Pembroke Pines, Florida, 33029

  • Teva Investigational Site 13189

    Philadelphia, Pennsylvania, 19107

  • Teva Investigational Site 13190

    Pittsburgh, Pennsylvania, 15241

  • Teva Investigational Site 13187

    Provo, Utah, 84604

  • Teva Investigational Site 13239

    Richmond, Virginia, 23233

  • Teva Investigational Site 13224

    San Antonio, Texas, 78229

  • Teva Investigational Site 13764

    San Jose, California, 95117

  • Teva Investigational Site 13235

    Shiloh, Illinois, 62269

  • Teva Investigational Site 13227

    Spokane, Washington, 99204

  • Teva Investigational Site 13204

    St Louis, Missouri, 63143

  • Teva Investigational Site 13252

    Stockton, California, 95207

  • Teva Investigational Site 13208

    Tallahassee, Florida, 32308

  • Teva Investigational Site 13255

    Tampa, Florida, 33607

  • Teva Investigational Site 13240

    Toledo, Ohio, 43606

  • Teva Investigational Site 13184

    Waco, Texas, 76712

  • Teva Investigational Site 13251

    Walnut Creek, California, 94598

  • Teva Investigational Site 13766

    Waterbury, Connecticut, 06708

Other trials in United States

Ukraine20 sites

  • Teva Investigational Site 58216

    Chernivtsi, 58023

  • Teva Investigational Site 58219

    Dnipropetrovsk, 49074

  • Teva Investigational Site 58225

    Dnipropetrovsk, 49101

  • Teva Investigational Site 58222

    Ivano-Frankivsk, 76018

  • Teva Investigational Site 58227

    Kharkiv, 61002

  • Teva Investigational Site 58213

    Kharkiv, 61007

  • Teva Investigational Site 58221

    Kharkiv, 61035

  • Teva Investigational Site 58223

    Kharkiv, 61039

  • Teva Investigational Site 58214

    Kremenchuk, 39617

  • Teva Investigational Site 58228

    Kryvyi Rih, 50082

  • Teva Investigational Site 58220

    Kyiv, 03680

  • Teva Investigational Site 58230

    Kyiv, 04050

  • Teva Investigational Site 58218

    Kyiv, 04107

  • Teva Investigational Site 58226

    Kyiv, 04201

  • Teva Investigational Site 58253

    Kyiv, ?03680

  • Teva Investigational Site 58234

    Sumy, 40022

  • Teva Investigational Site 58229

    Vinnytsia, 21001

  • Teva Investigational Site 58233

    Vinnytsia, 21001

  • Teva Investigational Site 58231

    Zaporizhzhya, 69063

  • Teva Investigational Site 58224

    Zhaporizhzhya, 69035

Other trials in Ukraine

Japan18 sites

  • Teva Investigational Site 84039

    Amagasaki, 660-8550

  • Teva Investigational Site 84053

    Ginowan, 901-2214

  • Teva Investigational Site 84049

    Hakodate, ?040-8611

  • Teva Investigational Site 84034

    Hiroshima, 734-8530

  • Teva Investigational Site 84036

    Kanazawa, 920-8530

  • Teva Investigational Site 84037

    Kishiwada-shi, 596-8501

  • Teva Investigational Site 84048

    Kobe, 651-0073

  • Teva Investigational Site 84044

    Kobe, 651-2273

  • Teva Investigational Site 84047

    Kodaira, 187-8510

  • Teva Investigational Site 84045

    Kumamoto, 862-0965

  • Teva Investigational Site 84043

    Mizunami-shi, 509-6134

  • Teva Investigational Site 84041

    Sagamihara, 252-5188

  • Teva Investigational Site 84031

    Tokyo, 103-0027

  • Teva Investigational Site 84032

    Tokyo, 103-0027

  • Teva Investigational Site 84038

    Toyama, 930-0194

  • Teva Investigational Site 84046

    Toyama, 930-8550

  • Teva Investigational Site 84035

    Toyoake-shi, 470-1192

  • Teva Investigational Site 84040

    Yokohama, 231-8682

Other trials in Japan

Germany16 sites

  • Teva Investigational Site 32559

    Bad Wörishofen, 86825

  • Teva Investigational Site 32556

    Berlin, 10717

  • Teva Investigational Site 32561

    Berlin, 10969

  • Teva Investigational Site 32570

    Berlin, 12159

  • Teva Investigational Site 32567

    Berlin, 13507

  • Teva Investigational Site 32564

    Berlin, 14059

  • Teva Investigational Site 32568

    Frankfurt, 60389

  • Teva Investigational Site 32560

    Frankfurt am Main, 60596

  • Teva Investigational Site 32562

    Hamburg, 22299

  • Teva Investigational Site 32566

    Hanover, 30173

  • Teva Investigational Site 32555

    Koblenz, 56068

  • Teva Investigational Site 32563

    Leipzig, 04357

  • Teva Investigational Site 32557

    Leipzig, 4275

  • Teva Investigational Site 32565

    Lübeck, 23552

  • Teva Investigational Site 32551

    Mainz, 55131

  • Teva Investigational Site 32569

    Witten, 58452

Other trials in Germany

Hungary16 sites

  • Teva Investigational Site 51216

    Balassagyarmat, 2660

  • Teva Investigational Site 51228

    Budapest, H-1036

  • Teva Investigational Site 51221

    Csorna, 9300

  • Teva Investigational Site 51220

    Debrecen, 4032

  • Teva Investigational Site 51223

    Debrecen, 4032

  • Teva Investigational Site 51255

    Dombóvár, 7200

  • Teva Investigational Site 51218

    Gödöllő, 2100

  • Teva Investigational Site 51222

    Győr, 9023

  • Teva Investigational Site 51227

    Hajdúnánás, 4080

  • Teva Investigational Site 51226

    Kaposvár, 7400

  • Teva Investigational Site 51231

    Kapuvár, 9330

  • Teva Investigational Site 51224

    Százhalombatta, 2440

  • Teva Investigational Site 51219

    Szeged, 6725

  • Teva Investigational Site 51225

    Szigetvár, 7900

  • Teva Investigational Site 51217

    Szombathely

  • Teva Investigational Site 51229

    Veszprém, 8200

Other trials in Hungary

Argentina11 sites

  • Teva Investigational Site 20040

    Buenos Aires, C1122AAK

  • Teva Investigational Site 20033

    Buenos Aires, C1426ABP

  • Teva Investigational Site 20035

    Buenos Aires

  • Teva Investigational Site 20041

    Córdoba, X5003DCE

  • Teva Investigational Site 20053

    Lanus, B1824 KAJ

  • Teva Investigational Site 20037

    Mar del Plata, CP 7600

  • Teva Investigational Site 20036

    Mendoza, 5500

  • Teva Investigational Site 20054

    Rosario, 2000

  • Teva Investigational Site 20032

    Rosario, S2000DBS

  • Teva Investigational Site 20046

    San Miguel de Tucumán, T4000CHE

  • Teva Investigational Site 20045

    San Rafael, 5600

Other trials in Argentina

Israel9 sites

  • Teva Investigational Site 80077

    Ashkelon, 7830604

  • Teva Investigational Site 80076

    Haifa, 3436212

  • Teva Investigational Site 80094

    Jerusalem, 91031

  • Teva Investigational Site 80078

    Jerusalem, 91120

  • Teva Investigational Site 80080

    Kfar Saba, 44281

  • Teva Investigational Site 80073

    Petah Tikva, 49100

  • Teva Investigational Site 80081

    Petah Tikva, 49100

  • Teva Investigational Site 80079

    Ramat Gan, 5262160

  • Teva Investigational Site 80075

    Rehovot, 76100

Other trials in Israel

Poland8 sites

  • Teva Investigational Site 53310

    Bialystok, 15-044

  • Teva Investigational Site 53315

    Bialystok, 15-276

  • Teva Investigational Site 53308

    Gdansk, 80-952

  • Teva Investigational Site 53311

    Krakow, 31-624

  • Teva Investigational Site 53314

    Lodz, 90-153

  • Teva Investigational Site 53312

    Lodz, 90-329

  • Teva Investigational Site 53313

    Poznan, 60-214

  • Teva Investigational Site 53309

    Tarnów, 33-100

Other trials in Poland

Romania8 sites

  • Teva Investigational Site 52108

    Brasov, 500051

  • Teva Investigational Site 52109

    Brasov, 500086

  • Teva Investigational Site 52107

    Bucharest, 11461

  • Teva Investigational Site 52105

    Bucharest, 50159

  • Teva Investigational Site 52104

    Cluj-Napoca, 400371

  • Teva Investigational Site 52111

    Deva

  • Teva Investigational Site 52106

    Târgu Mureş, 540136

  • Teva Investigational Site 52110

    Timișoara, 300310

Other trials in Romania

Russia8 sites

  • Teva Investigational Site 50350

    Barnaul, 656024

  • Teva Investigational Site 50354

    Kemerovo, 650099

  • Teva Investigational Site 50348

    Moscow, 115478

  • Teva Investigational Site 50351

    Moscow, 119991

  • Teva Investigational Site 50347

    Novosibirsk, 630091

  • Teva Investigational Site 50355

    Saint Petersburg, 194356

  • Teva Investigational Site 50352

    Saint Petersburg, 197089

  • Teva Investigational Site 50349

    Tomsk, 634063

Other trials in Russia

South Africa7 sites

  • Teva Investigational Site 90027

    Benoni, 1500

  • Teva Investigational Site 90028

    Bloemfontein, 9301

  • Teva Investigational Site 90026

    Cape Town, 7505

  • Teva Investigational Site 90031

    Cape Town, 7570

  • Teva Investigational Site 90029

    Cape Town, 7937

  • Teva Investigational Site 90032

    Durban, 4091

  • Teva Investigational Site 90030

    Durban, 4170

Other trials in South Africa

Mexico6 sites

  • Teva Investigational Site 21084

    Guadalajara, 44100

  • Teva Investigational Site 21085

    Guadalajara, 44130

  • Teva Investigational Site 21088

    Guadalajara, 44160

  • Teva Investigational Site 21089

    Guadalajara, 44220

  • Teva Investigational Site 21087

    Monterrey, 64718

  • Teva Investigational Site 21086

    Zapopan, 45070

Other trials in Mexico

Australia5 sites

  • Teva Investigational Site 78085

    Bedford Park, 5042

  • Teva Investigational Site 78083

    Nedlands, 6009

  • Teva Investigational Site 78088

    Parkville, 3052

  • Teva Investigational Site 78087

    Sherwood, 4075

  • Teva Investigational Site 78084

    Woolloongabba

Other trials in Australia

Turkey (Türkiye)5 sites

  • Teva Investigational Site 82042

    Ankara, 06290

  • Teva Investigational Site 82041

    Izmir, 35120

  • Teva Investigational Site 82040

    Kocaeli, 41380

  • Teva Investigational Site 82039

    Konya

  • Teva Investigational Site 82043

    Mersin, 33169

Other trials in Turkey (Türkiye)

Spain4 sites

  • Teva Investigational Site 31149

    Barcelona, 08025

  • Teva Investigational Site 31147

    Esplugues de Llobregat, 08950

  • Teva Investigational Site 31152

    Girona, 17005

  • Teva Investigational Site 31154

    Vitoria-Gasteiz, 01009

Other trials in Spain

Belgium3 sites

  • Teva Investigational Site 37054

    Brussels, 1200

  • Teva Investigational Site 37053

    Erpent, 5101

  • Teva Investigational Site 37055

    Ghent, 9000

Other trials in Belgium

Canada3 sites

  • Teva Investigational Site 11105

    Etobicoke, Ontario, M9V 4B4

  • Teva Investigational Site 11106

    Vancouver, British Columbia, V5Z 4E1

  • Teva Investigational Site 11109

    Windsor, N8X 5A6

Other trials in Canada

Czechia3 sites

  • Teva Investigational Site 54130

    Jablonec nad Nisou, 46601

  • Teva Investigational Site 54128

    Jindřichův Hradec, 377 01

  • Teva Investigational Site 54129

    Tábor, 39001

Other trials in Czechia

South Korea3 sites

  • Teva Investigational Site 87015

    Bucheon-si, 420-767

  • Teva Investigational Site 87016

    Seoul, 152-703

  • Teva Investigational Site 87014

    Seoul, 152703

Other trials in South Korea

France2 sites

  • Teva Investigational Site 35182

    Strasbourg, 67091

  • Teva Investigational Site 35183

    Toulouse, 31000

Other trials in France

New Zealand2 sites

  • Teva Investigational Site 79047

    Auckland, 1640

  • Teva Investigational Site 79046

    Auckland

Other trials in New Zealand

About this study

Official 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

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.

Conditions
Asthma
Being tested
Reslizumab, Placebo
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReslizumabDrug

    Reslizumab will be administered subcutaneously in a dose of 110 mg every 4 weeks.

  • PlaceboDrug

    Matching Placebo

Study groups in NCT02452190
Study groupRoleWhat they receive
ReslizumabExperimentalReslizumab
Receives: Drug: Reslizumab
PlaceboPlacebo comparatorMatching Placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment

    A CAE was defined as a clinically-judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors. Results are presented as adjusted means. For this analysis, the offset variable is calculated as the logarithm of treatment duration minus the summed duration of exacerbations during the treatment period.

    Measured: Day 1 to Week 52

Secondary outcomes (9)

  1. Change From Baseline to Week 52 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

    Change in pre-bronchodilator FEV1 from baseline to week 52 is presented. FEV1 is a standard measurement of air movement in the lungs of participants with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.

    Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

    Measured: Baseline, Week 52

  2. Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score

    AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses. Analysis of the change from baseline to each visit was performed using a MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

    Measured: Baseline, Week 52

  3. Change From Baseline to Week 52 in 6-item Asthma Control Questionnaire (ACQ-6) Score

    The ACQ-6 is a 6-item validated asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ-6 has a possible score ranges from 0 to 6, and the total score is the mean of all responses. The total score ranging from 0-6 (0=totally controlled and 6=severely uncontrolled). A higher score indicated poorer asthma control. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

    Measured: Baseline, Week 52

  4. Change From Baseline to Week 52 in Total Asthma Symptom Scores (Day and Night)

    Asthma symptoms were recorded by participant each day and night in an asthma control diary. Night score was assessed on a 5-point scale where 0=no symptoms, slept through night, to 4=bad night, no sleep. Day score was assessed on a 6-point scale where 0=very well, no symptoms, to 5= asthma very severe, unable to carry out daily activities. Total asthma symptom score was calculated by taking the sum of the night and day asthma symptom scores recorded, ranging from 0 (no symptom) to 9 (severe symptom). A lower symptom score indicated a better outcome. Analysis of the change from baseline to each visit was performed using a MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

    Measured: Baseline, Week 52

  5. Percentage of Asthma Control Days

    The percentage of asthma control days over 52 weeks of treatment is presented. An asthma control day was defined as a day on which the participant used less than or equal to 2 puffs of inhaled short-acting beta-agonist, had no nighttime awakenings, and experienced no asthma exacerbations. Analysis of the change from baseline to each visit was performed using a mixed effect MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

    Measured: Day 1 to Week 52

  6. Change From Baseline to Week 32 in St. George's Respiratory Questionnaire (SGRQ) Total Score

    The SGRQ is a 17-item questionnaire with 50 weighted responses. It provides a total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

    Measured: Baseline, Week 32

  7. Kaplan-Meier (K-M) Estimate of Probability (Percent [%]) of Not Experiencing a CAE by Week 52

    CAE was defined as a clinically judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit.

    The KM method was used to estimate and compare the distributions of time to first CAE between treatment groups. Participants without an event during the treatment period were censored at either the date of the end of treatment (Week 52) visit for participants who completed treatment or at the date of last dose (+4 weeks) for participants who discontinued early.

    Measured: Day 1 to Week 52

  8. Number of CAEs Requiring Hospitalization and/or Emergency Department Visits During 52 Weeks of Treatment

    A CAE was defined as a clinically judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. The frequency of CAEs over 52-week treatment period is expressed as adjusted CAEs rate in 52 weeks. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors (age group, blood eosinophil group) and number of prior exacerbations, and an offset variable.

    Measured: Day 1 to Week 52

  9. Number of Moderate Exacerbations During 52 Weeks of Treatment

    A moderate exacerbation was defined as a clinically judged deterioration in asthma control as determined by investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention requiring additional asthma controller medication that was not a systemic corticosteroid and did not result in an asthma-specific hospitalization or emergency department visit (that is, a medical intervention that did not otherwise meet the criteria for primary endpoint). Frequency of moderate exacerbations over 52-week treatment period is expressed as adjusted exacerbation rate in 52 weeks. Adjusted exacerbation rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors (age group, blood eosinophil group) and number of prior exacerbations, and an offset variable.

    Measured: Day 1 to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2015 (estimated)
  2. Study start28 Sep 2015
  3. Primary completion4 Dec 2017
  4. Study completion31 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
468 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02452190
Sponsor's protocol ID
C38072-AS-30025
Other IDs
2015-000865-29, 2015
Status last verified
Nov 2021
First submitted
13 May 2015
Last updated
9 Nov 2021
Data monitoring committee
No

Publications

  • Bernstein JA, Virchow JC, Murphy K, Maspero JF, Jacobs J, Adir Y, Humbert M, Castro M, Marsteller DA, McElhattan J, Hickey L, Garin M, Vanlandingham R, Brusselle G. Effect of fixed-dose subcutaneous reslizumab on asthma exacerbations in patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma: results from two phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2020 May;8(5):461-474. doi: 10.1016/S2213-2600(19)30372-8. Epub 2020 Feb 14.

    PubMed 32066536

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Reslizumab in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 226 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 226 sites in United States, Ukraine, Japan, Germany, Hungary and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment (time frame: Day 1 to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02452190, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.

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