AzTrials
AzTrials

COPDPhase 4NCT01443845

Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

A Phase 4 study testing Roflumilast in people with COPD and COPD Exacerbation, run by AstraZeneca at 338 sites in 17 countries.

Completed

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

Official record
Search all trials

Trial summary

To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
COPD, COPD Exacerbation, Lung Diseases
What is being tested?
Roflumilast
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,354 participants
Where
338 sitesin 17 countries
Study dates
30 Sep 2011to 31 Jan 2016
Phase
Phase 4
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Male or female patients at least 40 years of age
  • 2. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease [GOLD] 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted)
  • 3. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) < 70% at Screening (Visit 1)
  • 4. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)
  • 5. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)
  • 6. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
  • 7. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years

Who cannot join

  • 1. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable)
  • 2. Known alpha-1-antitrypsin deficiency
  • 3. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.)
  • 4. Body mass index (BMI) ≥ 45 kg/m2
  • 5. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer

Trial locations and contacts

338 sites in 17 countries.

338 sites in 17 countries

United States217 sites

  • Forest Investigative Site 125

    Abingdon, Virginia, 24210

  • Forest Investigative Site 086

    Altoona, Pennsylvania, 16601

  • Forest Investigative Site 157

    Ann Arbor, Michigan, 48106

  • Forest Investigative Site 081

    Anniston, Alabama, 36207

  • Forest Investigative Site 024

    Arlington, Texas, 76012

  • Forest Investigative Site 313

    Asheville, North Carolina, 28801

  • Forest Investigative Site 065

    Athens, Alabama, 35611

  • Forest Investigative Site 248

    Baltimore, Maryland, 21224

  • Forest Investigative Site 340

    Beaver, Pennsylvania, 15009

  • Forest Investigative Site 197

    Bellevue, Nebraska, 68123

  • Forest Investigative Site 074

    Bellflower, California, 90706

  • Forest Investigative Site 177

    Boerne, Texas, 78006

  • Forest Investigative Site 201

    Bolingbrook, Illinois, 60490

  • Forest Investigative Site 051

    Bowling Green, Kentucky, 42101

  • Forest Investigative Site 196

    Brandon, Florida, 33511

  • Forest Investigative Site 224

    Brandon, Florida, 33511

  • Forest Investigative Site 358

    Brandon, Florida, 33511

  • Forest Investigative Site 223

    Bristol, Tennessee, 37620

  • Forest Investigative Site 226

    Brooklyn, New York, 11229

  • Forest Investigative Site 193

    Burlington, North Carolina, 27215

  • Forest Investigative Site 333

    Butte, Montana, 59701

  • Forest Investigative Site 103

    Canton, Georgia, 30114

  • Forest Investigative Site 164

    Canton, Ohio, 44718

  • Forest Investigative Site 305

    Charleston, South Carolina, 29406

  • Forest Investigative Site 335

    Charleston, West Virginia, 25304

  • Forest Investigative Site 142

    Charlotte, North Carolina, 28207

  • Forest Investigative Site 259

    Charlotte, North Carolina, 28277

  • Forest Investigative Site 067

    Cherry Hill, New Jersey, 08003

  • Forest Investigative Site 033

    Chesterfield, Missouri, 63017

  • Forest Investigative Site 166

    Chiefland, Florida, 32626

  • Forest Investigative Site 149

    Cincinnati, Ohio, 45219

  • Forest Investigative Site 061

    Cincinnati, Ohio, 45231

  • Forest Investigative Site 040

    Cincinnati, Ohio, 45242

  • Forest Investigative Site 280

    Cincinnati, Ohio, 45267

  • Forest Investigative Site 111

    Clearwater, Florida, 33756

  • Forest Investigative Site 123

    Clearwater, Florida, 33765

  • Forest Investigative Site 327

    Clifton, New Jersey, 07012

  • Forest Investigative Site 008

    Coeur d'Alene, Idaho, 83814

  • Forest Investigative Site 181

    Colchester, Vermont, 05446

  • Forest Investigative Site 020

    Columbia, Maryland, 21044

  • Forest Investigative Site 009

    Columbus, Ohio, 43213

  • Forest Investigative Site 291

    Coral Gables, Florida, 33134

  • Forest Investigative Site 090

    Corsicana, Texas, 75110

  • Forest Investigative Site 135

    Council Bluffs, Iowa, 51503

  • Forest Investigative Site 075

    Crescent Springs, Kentucky, 41017

  • Forest Investigative Site 172

    Dallas, Texas, 75246

  • Forest Investigative Site 292

    Dawsonville, Georgia, 30534

  • Forest Investigative Site 353

    Dayton, Ohio, 45439

  • Forest Investigative Site 239

    DeFuniak Springs, Florida, 32435

  • Forest Investigative Site 341

    Detroit, Michigan, 48202

  • Forest Investigative Site 206

    Downers Grove, Illinois, 60515

  • Forest Investigative Site 120

    Downingtown, Pennsylvania, 19335

  • Forest Investigative Site 042

    Duluth, Georgia, 30096

  • Forest Investigative Site 119

    Eagle, Idaho, 83616

  • Forest Investigative Site 093

    Easley, South Carolina, 29640

  • Forest Investigative Site 303

    Edina, Minnesota, 55435

  • Forest Investigative Site 019

    Elizabeth City, North Carolina, 27909

  • Forest Investigative Site 136

    Elk Grove Village, Illinois, 60007

  • Forest Investigative Site 263

    Elwood, Indiana, 46036

  • Forest Investigative Site 062

    Erie, Pennsylvania, 16506

  • Forest Investigative Site 106

    Fall River, Massachusetts, 02720

  • Forest Investigative Site 050

    Fayetteville, Tennessee, 37334

  • Forest Investigative Site 131

    Florence, Alabama, 35630

  • Forest Investigative Site 001

    Fort Lauderdale, Florida, 33316

  • Forest Investigative Site 257

    Fort Mill, South Carolina, 29707

  • Forest Investigative Site 208

    Fort Smith, Arkansas, 72901

  • Forest Investigative Site 165

    Fort Walton Beach, Florida, 32547

  • Forest Investigative Site 267

    Fremont, Nebraska, 68025

  • Forest Investigative Site 337

    Fremont, Nebraska, 68028

  • Forest Investigative Site 060

    Fresno, California, 93721

  • Forest Investigative Site 329

    Fresno, California, 93726

  • Forest Investigative Site 056

    Fridley, Minnesota, 55432

  • Forest Investigative Site 245

    Fullerton, California, 92835

  • Forest Investigative Site 233

    Gaffney, South Carolina, 29340

  • Forest Investigative Site 102

    Gainesville, Florida, 32608

  • Forest Investigative Site 140

    Gainesville, Georgia, 30501

  • Forest Investigative Site 310

    Garden Grove, California, 92844

  • Forest Investigative Site 199

    Great Neck, New York, 11021

  • Forest Investigative Site 110

    Greenville, South Carolina, 29615

  • Forest Investigative Site 144

    Hackensack, New Jersey, 07601

  • Forest Investigative Site 351

    Hazard, Kentucky, 41701

  • Forest Investigative Site 079

    Henderson, Nevada, 89014

  • Forest Investigative Site 270

    Henderson, Nevada, 89052

  • Forest Investigative Site 003

    Hollywood, Florida, 33024

  • Forest Investigative Site 237

    Houston, Texas, 77030

  • Forest Investigative Site 271

    Houston, Texas, 77030

  • Forest Investigative Site 370

    Houston, Texas, 77030

  • Forest Investigative Site 195

    Houston, Texas, 77034

  • Forest Investigative Site 312

    Houston, Texas, 77079

  • Forest Investigative Site 332

    Huntsville, Texas, 77340

  • Forest Investigative Site 256

    Iowa City, Iowa, 52242

  • Forest Investigative Site 023

    Jacksonville, Florida, 32216

  • Forest Investigative Site 228

    Johnston, Rhode Island, 02919

  • Forest Investigative Site 328

    Kalamazoo, Michigan, 49009

  • Forest Investigative Site 077

    Kissimmee, Florida, 34741

  • Forest Investigative Site 330

    Kissimmee, Florida, 34741

  • Forest Investigative Site 342

    Lafayette, Indiana, 47904

  • Forest Investigative Site 273

    Lafayette, Louisiana, 70503

  • Forest Investigative Site 297

    Lakewood, California, 90712

  • Forest Investigative Site 030

    Lawrenceville, Georgia, 30046

  • Forest Investigative Site 128

    Lewiston, Maine, 04240

  • Forest Investigative Site 068

    Lexington, Kentucky, 40504

  • Forest Investigative Site 315

    Lincoln, Nebraska, 68506

  • Forest Investigative Site 108

    Lincoln, Nebraska, 68510

  • Forest Investigative Site 283

    Lincoln, Rhode Island, 02865

  • Forest Investigative Site 101

    Little Rock, Arkansas, 72205

  • Forest Investigative Site 063

    Livonia, Michigan, 48152

  • Forest Investigative Site 116

    Long Beach, California, 90822

  • Forest Investigative Site 232

    Longview, Texas, 75605

  • Forest Investigative Site 085

    Los Angeles, California, 90048

  • Forest Investigative Site 241

    Los Angeles, California, 90073

  • Forest Investigative Site 088

    Louisville, Kentucky, 40215

  • Forest Investigative Site 059

    Marion, Ohio, 43302

  • Forest Investigative Site 154

    Marion, Ohio, 43302

  • Forest Investigative Site 285

    Medford, Oregon, 97501

  • Forest Investigative Site 272

    Mesa, Arizona, 85206

  • Forest Investigative Site 027

    Miami, Florida, 33015

  • Forest Investigative Site 229

    Miami, Florida, 33136

  • Forest Investigative Site 115

    Miami, Florida, 33175

  • Forest Investigative Site 339

    Miami, Florida, 33186

  • Forest Investigative Site 293

    Michigan City, Indiana, 46360

  • Forest Investigative Site 029

    Missoula, Montana, 59808

  • Forest Investigative Site 073

    Mobile, Alabama, 36608

  • Forest Investigative Site 319

    Morgantown, West Virginia, 26505

  • Forest Investigative Site 264

    Muncie, Indiana, 47303

  • Forest Investigative Site 092

    Naples, Florida, 34119

  • Forest Investigative Site 071

    New York, New York, 10029

  • Forest Investigative Site 124

    Newark, Delaware, 19713

  • Forest Investigative Site 277

    Norristown, Pennsylvania, 19401

  • Forest Investigative Site 044

    North Dartmouth, Massachusetts, 02747

  • Forest Investigative Site 299

    Northridge, California, 91325

  • Forest Investigative Site 139

    Oak Lawn, Illinois, 60453

  • Forest Investigative Site 167

    Oklahoma City, Oklahoma, 73103

  • Forest Investigative Site 281

    Oklahoma City, Oklahoma, 73103

  • Forest Investigative Site 214

    Olathe, Kansas, 66061

  • Forest Investigative Site 345

    Omaha, Nebraska, 68114

  • Forest Investigative Site 070

    Opelousas, Louisiana, 70570

  • Forest Investigative Site 004

    Orlando, Florida, 32822

  • Forest Investigative Site 187

    Ormond Beach, Florida, 32174

  • Forest Investigative Site 053

    Owensboro, Kentucky, 42303

  • Forest Investigative Site 213

    Palo Alto, California, 94555

  • Forest Investigative Site 300

    Pelzer, South Carolina, 29669

  • Forest Investigative Site 069

    Pensacola, Florida, 32504

  • Forest Investigative Site 091

    Peoria, Arizona, 85381

  • Forest Investigative Site 227

    Peoria, Illinois, 61637

  • Forest Investigative Site 230

    Philadelphia, Pennsylvania, 19107

  • Forest Investigative Site 205

    Philadelphia, Pennsylvania, 19140

  • Forest Investigative Site 034

    Phoenix, Arizona, 85018

  • Forest Investigative Site 188

    Phoenix, Arizona, 85020

  • Forest Investigative Site 211

    Phoenix, Arizona, 85028

  • Forest Investigative Site 247

    Phoenix, Arizona, 85050

  • Forest Investigative Site 268

    Pismo Beach, California, 93449

  • Forest Investigative Site 336

    Pittsburgh, Pennsylvania, 15221

  • Forest Investigative Site 364

    Pittsburgh, Pennsylvania, 15240

  • Forest Investigative Site 344

    Pittsburgh, Pennsylvania, 15243

  • Forest Investigative Site 350

    Pittsfield, Massachusetts, 01201

  • Forest Investigative Site 161

    Ponte Vedra, Florida, 32081

  • Forest Investigative Site 087

    Port Orange, Florida, 32127

  • Forest Investigative Site 289

    Portland, Oregon, 97220

  • Forest Investigative Site 218

    Portland, Oregon, 97227

  • Forest Investigative Site 365

    Providence, Rhode Island, 02903

  • Forest Investigative Site 058

    Rapid City, South Dakota, 57702

  • Forest Investigative Site 202

    Richmond, Virginia, 23225

  • Forest Investigative Site 231

    Richmond, Virginia, 23229

  • Forest Investigative Site 045

    Richmond, Virginia, 23233

  • Forest Investigative Site 025

    Riverside, California, 92506

  • Forest Investigative Site 082

    Rochester, Minnesota, 55905

  • Forest Investigative Site 013

    Rochester, New York, 14618

  • Forest Investigative Site 204

    Rock Hill, South Carolina, 29732

  • Forest Investigative Site 143

    Roseville, California, 95661

  • Forest Investigative Site 104

    Sacramento, California, 95817

  • Forest Investigative Site 098

    Saint Charles, Missouri, 63301

  • Forest Investigative Site 109

    Saint Cloud, Florida, 34769

  • Forest Investigative Site 322

    Saint Joseph, Michigan, 49085

  • Forest Investigative Site 352

    San Diego, California, 92117

  • Forest Investigative Site 038

    San Diego, California, 92120

  • Forest Investigative Site 326

    San Jose, California, 95124

  • Forest Investigative Site 318

    Shelby, North Carolina, 28150

  • Forest Investigative Site 078

    Shelby, North Carolina, 28152

  • Forest Investigative Site 253

    Shelbyville, Tennessee, 37160

  • Forest Investigative Site 021

    Spartanburg, South Carolina, 29303

  • Forest Investigative Site 184

    Spokane, Washington, 99202

  • Forest Investigative Site 174

    Spokane, Washington, 99204

  • Forest Investigative Site 334

    Springfield, Illinois, 62703

  • Forest Investigative Site 117

    Springfield, Missouri, 65803

  • Forest Investigative Site 186

    St Louis, Missouri, 63141

  • Forest Investigative Site 288

    St Louis, Missouri, 63143

  • Forest Investigative Site 121

    St. Petersburg, Florida, 33704

  • Forest Investigative Site 357

    St. Petersburg, Florida, 33744

  • Forest Investigative Site 331

    Stamford, Connecticut, 06902

  • Forest Investigative Site 317

    Summit, New Jersey, 07901

  • Forest Investigative Site 097

    Sunset, Louisiana, 70584

  • Forest Investigative Site 066

    Syracuse, New York, 13210

  • Forest Investigative Site 217

    Tacoma, Washington, 98405

  • Forest Investigative Site 002

    Tamarac, Florida, 33312

  • Forest Investigative Site 287

    Tampa, Florida, 33607

  • Forest Investigative Site 052

    Tampa, Florida, 33613

  • Forest Investigative Site 010

    Tipton, Pennsylvania, 16684

  • Forest Investigative Site 346

    Toledo, Ohio, 43606

  • Forest Investigative Site 316

    Topeka, Kansas, 66606

  • Forest Investigative Site 209

    Torrance, California, 90502

  • Forest Investigative Site 072

    Towson, Maryland, 21204

  • Forest Investigative Site 236

    Tulsa, Oklahoma, 74135

  • Forest Investigative Site 049

    Tyler, Texas, 75708

  • Forest Investigative Site 012

    Union, South Carolina, 29379

  • Forest Investigative Site 064

    Uniontown, Pennsylvania, 15401

  • Forest Investigative Site 017

    Waterbury, Connecticut, 06708

  • Forest Investigative Site 146

    West Allis, Wisconsin, 53227

  • Forest Investigative Site 158

    West Seneca, New York, 14224

  • Forest Investigative Site 301

    Wichita, Kansas, 67205

  • Forest Investigative Site 176

    Wilmington, North Carolina, 28451

  • Forest Investigative Site 282

    Winston-Salem, North Carolina, 27103

  • Forest Investigative Site 314

    Winston-Salem, North Carolina, 27103

  • Forest Investigative Site 011

    Winter Park, Florida, 32789

  • Forest Investigative Site 348

    Winter Park, Florida, 32792

  • Forest Investigative Site 321

    Woodstock, Georgia, 30189

  • Forest Investigative Site 105

    Zanesville, Ohio, 43701

Other trials in United States

Ukraine23 sites

  • Forest Investigative Site 699

    Cherkasy, 18009

  • Forest Investigative Site 691

    Dnipropetrovsk, 49074

  • Forest Investigative Site 692

    Donetsk, 83003

  • Forest Investigative Site 689

    Donetsk, 83099

  • Forest Investigative Site 690

    Ivano-Frankivsk, 76018

  • Forest Investigative Site 697

    Kharkiv, 61035

  • Forest Investigative Site 693

    Kharkiv, 61039

  • Forest Investigative Site 682

    Kharkiv, 61124

  • Forest Investigative Site 709

    Kremenchuk

  • Forest Investigative Site 698

    Kyiv, 3049

  • Forest Investigative Site 683

    Kyiv, 3680

  • Forest Investigative Site 684

    Kyiv, 3680

  • Forest Investigative Site 687

    Kyiv, 3680

  • Forest Investigative Site 685

    Kyiv, 4050

  • Forest Investigative Site 681

    Lviv, 79013

  • Forest Investigative Site 708

    Mykolayiv, 54003

  • Forest Investigative Site 706

    Poltava, 36038

  • Forest Investigative Site 695

    Sumy, 40000

  • Forest Investigative Site 707

    Vinnitsa, 21001

  • Forest Investigative Site 696

    Zaporizhzhya, 69035

  • Forest Investigative Site 694

    Zaporizhzhya, 69106

  • Forest Investigative Site 705

    Zaporizhzhya, 69118

  • Forest Investigative Site 688

    Zaporizhzhya, 69600

Other trials in Ukraine

Argentina20 sites

  • Forest Investigative Site 403

    Buenos Aires, Buenos Aires, B1842DID

  • Forest Investigative Site 411

    Buenos Aires, C1015ABO

  • Forest Investigative Site 414

    Buenos Aires, C1122AAK

  • Forest Investigative Site 419

    Buenos Aires, C1426ABP

  • Forest Investigative Site 416

    Buenos Aires, C1428DDE

  • Forest Investigative Site 418

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425DES

  • Forest Investigative Site 415

    Derqui Pilar - Buenos Aires, B1629ODT

  • Forest Investigative Site 402

    Florida, Buenos Aires, B1602DOH

  • Forest Investigative Site 405

    La Plata, Buenos Aires, 1900

  • Forest Investigative Site 417

    La Plata, 1900

  • Forest Investigative Site 406

    Lanús Este, Buenos Aires, B1824 KAJ

  • Forest Investigative Site 413

    Mar del Plata, Buenos Aires, CP 7600

  • Forest Investigative Site 404

    Mendoza, Mendoza Province, M5500CCG

  • Forest Investigative Site 420

    Mendoza, 5500

  • Forest Investigative Site 407

    Paraná, Entre Ríos Province, E3100BHK

  • Forest Investigative Site 412

    Rosario, Santa Fe Province, S2000DBS

  • Forest Investigative Site 409

    Rosario, Santa Fe Province, S2000KZD

  • Forest Investigative Site 410

    San Juan Bautista, 1888

  • Forest Investigative Site 401

    San Miguel de Tucumán, T4000IFL

  • Forest Investigative Site 408

    Santa Fe, 3000

Other trials in Argentina

Russia17 sites

  • Forest Investigative Site 608

    Barnaul, 656045

  • Forest Investigative Site 602

    Kazan', 420015

  • Forest Investigative Site 618

    Kemerovo, 650000

  • Forest Investigative Site 609

    Krasnodar, 350012

  • Forest Investigative Site 614

    Krasnoyarsk, 660022

  • Forest Investigative Site 617

    Moscow, 125367

  • Forest Investigative Site 605

    Novosibirsk, 630099

  • Forest Investigative Site 606

    Saint Petersburg, 191025

  • Forest Investigative Site 612

    Saint Petersburg, 193231

  • Forest Investigative Site 619

    Saint Petersburg, 194044

  • Forest Investigative Site 604

    Saint Petersburg, 194358

  • Forest Investigative Site 611

    Saint Petersburg, 196084

  • Forest Investigative Site 610

    Saint Petersburg, 196247

  • Forest Investigative Site 601

    Saint Petersburg, 197110

  • Forest Investigative Site 600

    Saint Petersburg, 197706

  • Forest Investigative Site 607

    Tomsk, 634063

  • Forest Investigative Site 620

    Yaroslavl, 150003

Other trials in Russia

Philippines9 sites

  • Forest Investigative Site 569

    Cavite, 4114

  • Forest Investigative Site 567

    Iloilo City, 5000

  • Forest Investigative Site 568

    Iloilo City, 5000

  • Forest Investigative Site 565

    Manila, 1000

  • Forest Investigative Site 563

    Pasig, 1600

  • Forest Investigative Site 562

    Quezon City, 1100

  • Forest Investigative Site 564

    Quezon City, 1100

  • Forest Investigative Site 566

    Quezon City, 1109

  • Forest Investigative Site 561

    Quezon City, 1118

Other trials in Philippines

Peru8 sites

  • Forest Investigative Site 543

    Bellavista, Callao 2

  • Forest Investigative Site 550

    Lima, Lima 11

  • Forest Investigative Site 551

    Lima, Lima 13

  • Forest Investigative Site 545

    Lima, Lima 18

  • Forest Investigative Site 546

    Lima, Lima 27

  • Forest Investigative Site 549

    Lima, Lima 31

  • Forest Investigative Site 544

    Lima, Lima 33

  • Forest Investigative Site 541

    Pueblo Libre, Lima 21

Other trials in Peru

Romania8 sites

  • Forest Investigative Site 585

    Brasov, 500112

  • Forest Investigative Site 586

    Bucharest, 10457

  • Forest Investigative Site 587

    Bucharest, 30303

  • Forest Investigative Site 588

    Bucharest, 31298

  • Forest Investigative Site 584

    Bucharest, 50159

  • Forest Investigative Site 582

    Bucharest, 50554

  • Forest Investigative Site 581

    Iași, 700115

  • Forest Investigative Site 583

    Iași, 700115

Other trials in Romania

Serbia7 sites

  • Forest Investigative Site 622

    Belgrade, 11000

  • Forest Investigative Site 623

    Belgrade, 11000

  • Forest Investigative Site 624

    Belgrade, 11000

  • Forest Investigative Site 625

    Belgrade, 11000

  • Forest Investigative Site 627

    Kamenitz, 21204

  • Forest Investigative Site 629

    Knez-Selo, Nišava District, 18204

  • Forest Investigative Site 628

    Kragujevac, 34000

Other trials in Serbia

Canada5 sites

  • Forest Investigative Site 302

    Burlington, Ontario, L7N 3V2

  • Forest Investigative Site 235

    Calgary, Alberta, T2K5R7

  • Forest Investigative Site 185

    Montreal, Quebec, H2R 1V6

  • Forest Investigative Site 162

    North Vancouver, British Columbia, V7M 2H9

  • Forest Investigative Site 127

    Saskatoon, Saskatchewan, S7N0W8

Other trials in Canada

Malaysia4 sites

  • Forest Investigative Site 505

    Batu Caves, 68100

  • Forest Investigative Site 501

    Kuala Lumpur, 50588

  • Forest Investigative Site 504

    Kuala Lumpur, 59100

  • Forest Investigative Site 502

    Kuantan, 25100

Other trials in Malaysia

Mexico4 sites

  • Forest Investigative Site 524

    Guadalajara, 44100

  • Forest Investigative Site 526

    Mérida, Yucatán, 97070

  • Forest Investigative Site 522

    Monterrey, Nuevo León, 64460

  • Forest Investigative Site 521

    Monterrey, 64060

Other trials in Mexico

Taiwan4 sites

  • Forest Investigative Site 723

    Kaohsiung Hsien, 833

  • Forest Investigative Site 724

    Puzih City, 61363

  • Forest Investigative Site 725

    Taipei, 100

  • Forest Investigative Site 722

    Taipei, 11490

Other trials in Taiwan

Thailand4 sites

  • Forest Investigative Site 664

    Bangkok, 10400

  • Forest Investigative Site 663

    Bangkok, 11000

  • Forest Investigative Site 662

    Hat Yai, Changwat Songkhla, 90110

  • Forest Investigative Site 661

    Muang, 40002

Other trials in Thailand

Spain3 sites

  • Forest Investigative Site 641

    Cadiz, 11009

  • Forest Investigative Site 647

    Loja, 18300

  • Forest Investigative Site 644

    Salt, 17190

Other trials in Spain

Colombia2 sites

  • Forest Investigative Site 442

    Bogotá, 111111

  • Forest Investigative Site 443

    Bogotá, 111711

Other trials in Colombia

Italy2 sites

  • Forest Investigative Site 461

    Chieti, 66013

  • Forest Investigative Site 464

    Roma, 00168

Other trials in Italy

Chile1 site

  • Forest Investigative Site 421

    Talcahuano, 4270918

Other trials in Chile

About this study

Official title: Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS)

To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.

Being tested
Roflumilast, Placebo
Keywords
COPD, Exacerbations, Roflumilast, Daliresp
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiration Disorders

What participants receive

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

  • RoflumilastDrug

    Also called Daliresp

    Roflumilast 500 µg, oral administration, once per day

  • PlaceboDrug

    Dose-matched placebo, oral administration, once per day.

Study groups in NCT01443845
Study groupRoleWhat they receive
1ExperimentalRoflumilast
Receives: Drug: Roflumilast
2Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year.

    Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.

    Measured: Baseline to Week 52

Secondary outcomes (3)

  1. Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)

    Rate of moderate or severe COPD exacerbations, defined as requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.

    Measured: Week 0 (Visit 2) to Week 52

  2. Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics

    Rate of moderate or severe COPD exacerbations treated with antibiotics during the double-blind treatment period.

    Measured: Week 0 (Visit 2) to Week 52

  3. Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)

    Mean change from randomization (Visit 2) over 52 weeks of treatment in predose forced expiratory volume in 1 second (FEV1)

    Measured: Week 0 (Visit 2) 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 posted30 Sep 2011 (estimated)
  2. Study start30 Sep 2011
  3. Primary completion30 Nov 2015
  4. Study completion31 Jan 2016

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
2,354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01443845
Sponsor's protocol ID
ROF-MD-07
Status last verified
Mar 2017
First submitted
28 Sep 2011
Last updated
13 Apr 2017
Data monitoring committee
No

Publications

  • Martinez FJ, Rabe KF, Calverley PMA, Fabbri LM, Sethi S, Pizzichini E, McIvor A, Anzueto A, Alagappan VKT, Siddiqui S, Reisner C, Zetterstrand S, Roman J, Purkayastha D, Bagul N, Rennard SI. Determinants of Response to Roflumilast in Severe Chronic Obstructive Pulmonary Disease. Pooled Analysis of Two Randomized Trials. Am J Respir Crit Care Med. 2018 Nov 15;198(10):1268-1278. doi: 10.1164/rccm.201712-2493OC.

    PubMed 29763572

  • Karpefors M, Weatherall J. The Tendril Plot-a novel visual summary of the incidence, significance and temporal aspects of adverse events in clinical trials. J Am Med Inform Assoc. 2018 Aug 1;25(8):1069-1073. doi: 10.1093/jamia/ocy016.

    PubMed 29579254

  • Martinez FJ, Rabe KF, Sethi S, Pizzichini E, McIvor A, Anzueto A, Alagappan VK, Siddiqui S, Rekeda L, Miller CJ, Zetterstrand S, Reisner C, Rennard SI. Effect of Roflumilast and Inhaled Corticosteroid/Long-Acting beta2-Agonist on Chronic Obstructive Pulmonary Disease Exacerbations (RE(2)SPOND). A Randomized Clinical Trial. Am J Respir Crit Care Med. 2016 Sep 1;194(5):559-67. doi: 10.1164/rccm.201607-1349OC.

    PubMed 27585384

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Roflumilast in people with COPD and COPD Exacerbation, run by AstraZeneca at 338 sites in 17 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 7 inclusion and 5 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 338 sites in United States, Ukraine, Argentina, Russia, Philippines and 12 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 25 Jan 2017). 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?

Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. (time frame: Baseline 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 NCT01443845, which also lists 3 linked publications.

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 13 Apr 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in