AzTrials
AzTrials

COPDPhase 3TRITONNCT04320342

A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD

A Phase 3 study testing Beclomethasone Dipropionate, Glycopyrronium Bromide and Formoterol Fumarate in people with COPD and COPD Exacerbation, run by Chiesi Farmaceutici S.p.A. at 436 sites in 10 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

The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes in the target subject population. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
COPD, COPD Exacerbation
What is being tested?
Beclomethasone Dipropionate, Glycopyrronium Bromide and Formoterol Fumarate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,406 participants
Where
436 sitesin 10 countries
Study dates
27 Apr 2022to 12 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Signed and dated written informed consent must be obtained prior to initiating any study-related procedures
  • Outpatient
  • Male or female subjects aged ≥40 years
  • Female subjects:
  • WOCBP fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signing of the informed consent form and until the follow-up contact or ii. WOCBP with non-fertile male partners (contraception is not required in this case).
  • Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile as per definitions given in Appendix 5). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges)
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  • COPD diagnosis for at least 12 months before the screening visit in accordance with the definition by the GOLD 2020 Report
  • Current or ex-smokers who quit smoking at least 6 months prior to screening with a smoking history of at least 10 pack-years [pack-years = (number of cigarettes per day x number of years)/20]
  • COPD Assessment Test (CAT) score ≥10
  • A pre- and post-bronchodilator FEV1/FVC ratio <0.70 at screening
  • A post-bronchodilator FEV1 <50% predicted normal at screening and a documented history of ≥1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator FEV1 ≥50% and <80% of predicted normal at screening and a documented history of ≥2 moderate COPD exacerbations or ≥1 severe COPD exacerbation in the previous 12 months
  • Subjects receiving daily inhaled maintenance therapy for their COPD, at a stable dose for at least 3 months prior to the screening and randomization visits
  • Documentation (including imagery and report) of chest x-ray (CXR) or CT scan performed within 6 months prior to the screening visit, without evidence of significant abnormalities (other than those related to the presence of COPD).
  • A cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary.

Who cannot join

  • Female subjects who are pregnant (as evident by a positive urine hCG or serum β-hCG test) or lactating
  • Subjects using the following medications prior to the screening visit and during the run-in period:
  • Systemic/oral/parenteral corticosteroids in the prior 4 weeks
  • Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) or COPD exacerbation in the prior 4 weeks
  • Any long-term chronic maintenance use of antibiotic treatment in the prior 4 weeks
  • Oral xanthine derivatives (e.g. theophylline) in the prior 7 days
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  • A moderate or severe COPD exacerbation or a respiratory tract infection (e.g., pneumonia) that has not resolved ≤14 days prior to the screening visit or during the run-in period
  • Current treatment with non-cardioselective β-blockers
  • Requirement of long term (> 15 hours daily) oxygen therapy
  • Known respiratory disorders other than COPD which may impact the efficacy of the study drug according to investigator's judgement.
  • Lung transplant surgery or lung volume reduction surgery (subjects with lung volume reduction surgery are excluded if the procedure was performed within 1 year before the Screening visit)
  • Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator, would prevent use of anticholinergic agents
  • History of hypersensitivity to M3 receptor antagonists, β2 agonists, corticosteroids or any of the excipients contained in any of the study drugs used in the trial which may raise contra-indications or impact the efficacy of the study drug according to the investigator's judgement
  • Subject has severe, acute or uncontrolled cardiovascular condition (such as but not limited to unstable ischemic heart disease, NYHA Class IV, left ventricular failure, acute myocardial infarction or unstable angina) in the last 6 months
  • An abnormal and clinically significant 12-lead ECG at either the screening or randomization visit. This is characterized as but not limited to any of the following findings:
  • Atrial fibrillation (AF) with rapid ventricular response > 120 bpm
  • Ventricular tachycardias (sustained, non-sustained [>3 up to 30 sec])
  • Evidence of Mobitz Type II second degree or third-degree atrioventricular block
  • Prolonged QTcF (>450ms for males, or >470ms for females). This criterion is not applicable for subjects with a pacemaker or permanent AF.
  • Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug according to investigator's judgement
  • Unstable or uncontrolled concurrent disease which may impact the efficacy or safety of the study drug or the subject's participation in the study according to investigator's judgment
  • Malignancy that has not been in complete remission for at least 1 year or any untreated localized carcinomas
  • History of alcohol abuse and/or substance/drug abuse within 12 months prior to the screening visit
  • Receipt of any other investigational drug within 1 month or 5 half-lives (whichever is greater) prior to the screening visit or have been previously randomized in this trial, or are currently participating in another clinical trial
  • Currently in the acute phase of a pulmonary rehabilitation program within 4 weeks before the screening visit or planning to enroll in the acute phase of such a program during the study. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded
  • Mentally or legally incapacitated, or subjects incarcerated as a result of an official or judicial order
  • Major surgery in the 3 months prior to the screening visit or have a planned surgery during the trial
  • Non-satisfactory compliance with the eDiary (<65% or >135%) during the run-in period
  • Subjects requiring the use of spacer device or nebulizer for administration of maintenance COPD therapies.
  • Veins unsuitable for repeat venipuncture
  • Blood donation or blood loss (≥450mL) in the 4 weeks before randomization

Trial locations and contacts

436 sites in 10 countries.

436 sites in 10 countries

United States276 sites

  • Chiesi Clinical Trial Site 840223

    Adairsville, Georgia, 30103

  • Chiesi Clinical Trial Site 840445

    Akron, Ohio, 44313

  • Chiesi Clinical Trial Site 840116

    Altamonte Springs, Florida, 32701

  • Chiesi Clinical Trial Site 840222

    Anderson, South Carolina, 29621

  • Chiesi Clinical Trial Site 840435

    Anderson, South Carolina, 29621

  • Chiesi Clinical Trial Site 840441

    Aurora, Colorado, 80014

  • Chiesi Clinical Trial Site 840268

    Aventura, Florida, 33180

  • Chiesi Clinical Trial Site 840447

    Baltimore, Maryland, 21237

  • Chiesi Clinical Trial Site 840376

    Baltimore, Maryland, 21287

  • Chiesi Clinical Trial Site 840451

    Bangor, Maine, 04401

  • Chiesi Clinical Trial Site 840101

    Baytown, Texas, 77521

  • Chiesi Clinical Trial Site 840300

    Beaver, Pennsylvania, 15009

  • Chiesi Clinical Trial Site 840297

    Berlin, New Jersey, 08009

  • Chiesi Clinical Trial Site 840330

    Binghamton, New York, 13905

  • Chiesi Clinical Trial Site 840350

    Birmingham, Alabama, 35215-7502

  • Chiesi Clinical Trial Site 840114

    Boerne, Texas, 78006

  • Chiesi Clinical Trial Site 840229

    Boulder, Colorado, 80302

  • Chiesi Clinical Trial Site 840192

    Brandon, Florida, 33511

  • Chiesi Clinical Trial Site 840397

    Brooklyn, New York, 11235

  • Chiesi Clinical Trial Site 840310

    Brooksville, Florida, 34613

  • Chiesi Clinical Trial Site 840254

    Buffalo, New York, 14201

  • Chiesi Clinical Trial Site 840307

    Buffalo, New York, 14203

  • Chiesi Clinical Trial Site 840406

    Chandler, Arizona, 85224

  • Chiesi Clinical Trial Site 840431

    Charleston, South Carolina, 29406

  • Chiesi Clinical Trial Site 840215

    Charlotte, North Carolina, 28207

  • Chiesi Clinical Trial Site 840366

    Charlotte, North Carolina, 28210

  • Chiesi Clinical Trial Site 840158

    Charlotte, North Carolina, 28277

  • Chiesi Clinical Trial Site 840305

    Chattanooga, Tennessee, 37404

  • Chiesi Clinical Trial Site 840278

    Chesterfield, Missouri, 63017

  • Chiesi Clinical Trial Site 840321

    Chicago, Illinois, 60602

  • Chiesi Clinical Trial Site 840365

    Chicago Ridge, Illinois, 60415

  • Chiesi Clinical Trial Site 840240

    Chiefland, Florida, 32626

  • Chiesi Clinical Trial Site 840104

    Cincinnati, Ohio, 45231

  • Chiesi Clinical Trial Site 840357

    Cincinnati, Ohio, 45242

  • Chiesi Clinical Trial Site 840153

    Clearwater, Florida, 33756

  • Chiesi Clinical Trial Site 840337

    Colchester, Vermont, 05446

  • Chiesi Clinical Trial Site 840155

    Columbia, Missouri, 65203

  • Chiesi Clinical Trial Site 840334

    Columbia, South Carolina, 29201

  • Chiesi Clinical Trial Site 840130

    Columbia, South Carolina, 29204

  • Chiesi Clinical Trial Site 840430

    Columbia, South Carolina, 29223

  • Chiesi Clinical Trial Site 840218

    Columbus, Georgia, 31904

  • Chiesi Clinical Trial Site 840414

    Columbus, Georgia, 31904

  • Chiesi Clinical Trial Site 840124

    Columbus, Ohio, 43215

  • Chiesi Clinical Trial Site 840272

    Coral Gables, Florida, 33134

  • Chiesi Clinical Trial Site 840304

    Coral Gables, Florida, 33134

  • Chiesi Clinical Trial Site 840437

    Cordele, Georgia, 31015

  • Chiesi Clinical Trial Site 840318

    Council Bluffs, Iowa, 51503

  • Chiesi Clinical Trial Site 840404

    Covina, California, 91723

  • Chiesi Clinical Trial Site 840450

    Cranston, Rhode Island, 02920

  • Chiesi Clinical Trial Site 840207

    Crowley, Louisiana, 70526

  • Chiesi Clinical Trial Site 840332

    Cumberland, Rhode Island, 02864

  • Chiesi Clinical Trial Site 840193

    Cutler Bay, Florida, 33157

  • Chiesi Clinical Trial Site 840311

    Cutler Bay, Florida, 33189

  • Chiesi Clinical Trial Site 840335

    Cutler Bay, Florida, 33189

  • Chiesi Clinical Trial Site 840146

    Cypress, Texas, 77429

  • Chiesi Clinical Trial Site 840413

    Dallas, Texas, 75230

  • Chiesi Clinical Trial Site 840426

    Dayton, Ohio, 45424

  • Chiesi Clinical Trial Site 840141

    Daytona Beach, Florida, 32117

  • Chiesi Clinical Trial Site 840325

    Dearborn, Michigan, 48124

  • Chiesi Clinical Trial Site 840400

    Dearborn, Michigan, 48126

  • Chiesi Clinical Trial Site 840133

    DeLand, Florida, 32720

  • Chiesi Clinical Trial Site 840409

    Denver, North Carolina, 28037

  • Chiesi Clinical Trial Site 840269

    Doral, Florida, 33122

  • Chiesi Clinical Trial Site 840186

    Dothan, Alabama, 36303

  • Chiesi Clinical Trial Site 840308

    DuBois, Pennsylvania, 15801

  • Chiesi Clinical Trial Site 840403

    Durham, North Carolina, 27705

  • Chiesi Clinical Trial Site 840209

    Escondido, California, 92025

  • Chiesi Clinical Trial Site 840423

    Everett, Washington, 98208

  • Chiesi Clinical Trial Site 840214

    Fall River, Massachusetts, 02723

  • Chiesi Clinical Trial Site 840183

    Farmington Hills, Michigan, 48336

  • Chiesi Clinical Trial Site 840444

    Fayette, Mississippi, 39069

  • Chiesi Clinical Trial Site 840340

    Flint, Michigan, 48504

  • Chiesi Clinical Trial Site 840401

    Flint, Michigan, 48532

  • Chiesi Clinical Trial Site 840368

    Flushing, New York, 11355

  • Chiesi Clinical Trial Site 840258

    Foley, Alabama, 36535

  • Chiesi Clinical Trial Site 840211

    Fort Mill, South Carolina, 29707

  • Chiesi Clinical Trial Site 840351

    Franklin, Tennessee, 37067

  • Chiesi Clinical Trial Site 840182

    Gaffney, South Carolina, 29340

  • Chiesi Clinical Trial Site 840428

    Gastonia, North Carolina, 28054

  • Chiesi Clinical Trial Site 840111

    Greenville, South Carolina, 29615

  • Chiesi Clinical Trial Site 840407

    Hammond, Indiana, 46324

  • Chiesi Clinical Trial Site 840303

    Hialeah, Florida, 33010

  • Chiesi Clinical Trial Site 840163

    Hialeah, Florida, 33012

  • Chiesi Clinical Trial Site 840165

    Hialeah, Florida, 33012

  • Chiesi Clinical Trial Site 840238

    Hialeah, Florida, 33012

  • Chiesi Clinical Trial Site 840265

    Hialeah, Florida, 33012

  • Chiesi Clinical Trial Site 840241

    Hialeah, Florida, 33015

  • Chiesi Clinical Trial Site 840253

    Hialeah, Florida, 33015

  • Chiesi Clinical Trial Site 840184

    Hialeah, Florida, 33016

  • Chiesi Clinical Trial Site 840267

    Hialeah, Florida, 33016

  • Chiesi Clinical Trial Site 840354

    Hialeah Gardens, Florida, 33016

  • Chiesi Clinical Trial Site 840256

    Hialeah Gardens, Florida, 33066

  • Chiesi Clinical Trial Site 840284

    Houston, Texas, 77008

  • Chiesi Clinical Trial Site 840411

    Houston, Texas, 77008

  • Chiesi Clinical Trial Site 840389

    Houston, Texas, 77030

  • Chiesi Clinical Trial Site 840185

    Houston, Texas, 77084

  • Chiesi Clinical Trial Site 840224

    Houston, Texas, 77098

  • Chiesi Clinical Trial Site 840408

    Humble, Texas, 77396

  • Chiesi Clinical Trial Site 840236

    Huntersville, North Carolina, 28078

  • Chiesi Clinical Trial Site 840279

    Jasper, Alabama, 35501

  • Chiesi Clinical Trial Site 840156

    Jenkintown, Pennsylvania, 19046

  • Chiesi Clinical Trial Site 840306

    Johnson City, Tennessee, 37601

  • Chiesi Clinical Trial Site 840102

    Katy, Texas, 77494

  • Chiesi Clinical Trial Site 840274

    Katy, Texas, 77494

  • Chiesi Clinical Trial Site 840432

    Kerrville, Texas, 78028

  • Chiesi Clinical Trial Site 840302

    Kettering, Ohio, 45439

  • Chiesi Clinical Trial Site 840421

    Kingwood, West Virginia, 26537

  • Chiesi Clinical Trial Site 840200

    Kissimmee, Florida, 34741

  • Chiesi Clinical Trial Site 840171

    Knoxville, Tennessee, 37909

  • Chiesi Clinical Trial Site 840427

    La Palma, California, 90623

  • Chiesi Clinical Trial Site 840232

    Lakeland, Florida, 33803

  • Chiesi Clinical Trial Site 840160

    Lampasas, Texas, 76550

  • Chiesi Clinical Trial Site 840420

    Lancaster, South Carolina, 29720

  • Chiesi Clinical Trial Site 840213

    Las Vegas, Nevada, 840213

  • Chiesi Clinical Trial Site 840285

    Las Vegas, Nevada, 89106

  • Chiesi Clinical Trial Site 840299

    Las Vegas, Nevada, 89123

  • Chiesi Clinical Trial Site 840390

    Lawrenceville, Georgia, 30044

  • Chiesi Clinical Trial Site 840227

    Lawrenceville, Georgia, 30046

  • Chiesi Clinical Trial Site 840113

    Leesburg, Florida, 34748

  • Chiesi Clinical Trial Site 840281

    Lincoln, Nebraska, 68506

  • Chiesi Clinical Trial Site 840358

    Lomita, California, 90717

  • Chiesi Clinical Trial Site 840264

    Manassas, Virginia, 20110

  • Chiesi Clinical Trial Site 840386

    Mauldin, South Carolina, 29662

  • Chiesi Clinical Trial Site 840233

    Maumee, Ohio, 43537

  • Chiesi Clinical Trial Site 840424

    McAllen, Texas, 78503

  • Chiesi Clinical Trial Site 840119

    McKinney, Texas, 75069

  • Chiesi Clinical Trial Site 840203

    Medford, Oregon, 97504

  • Chiesi Clinical Trial Site 840372

    Miami, Florida, 33122

  • Chiesi Clinical Trial Site 840137

    Miami, Florida, 33125

  • Chiesi Clinical Trial Site 840289

    Miami, Florida, 33125

  • Chiesi Clinical Trial Site 840377

    Miami, Florida, 33125

  • Chiesi Clinical Trial Site 840387

    Miami, Florida, 33125

  • Chiesi Clinical Trial Site 840326

    Miami, Florida, 33126

  • Chiesi Clinical Trial Site 840175

    Miami, Florida, 33133

  • Chiesi Clinical Trial Site 840346

    Miami, Florida, 33133

  • Chiesi Clinical Trial Site 840347

    Miami, Florida, 33134

  • Chiesi Clinical Trial Site 840205

    Miami, Florida, 33135

  • Chiesi Clinical Trial Site 840247

    Miami, Florida, 33135

  • Chiesi Clinical Trial Site 840341

    Miami, Florida, 33135

  • Chiesi Clinical Trial Site 840148

    Miami, Florida, 33144

  • Chiesi Clinical Trial Site 840239

    Miami, Florida, 33144

  • Chiesi Clinical Trial Site 840312

    Miami, Florida, 33144

  • Chiesi Clinical Trial Site 840355

    Miami, Florida, 33144

  • Chiesi Clinical Trial Site 840388

    Miami, Florida, 33144

  • Chiesi Clinical Trial Site 840237

    Miami, Florida, 33155

  • Chiesi Clinical Trial Site 840261

    Miami, Florida, 33155

  • Chiesi Clinical Trial Site 840262

    Miami, Florida, 33155

  • Chiesi Clinical Trial Site 840280

    Miami, Florida, 33155

  • Chiesi Clinical Trial Site 840178

    Miami, Florida, 33165

  • Chiesi Clinical Trial Site 840292

    Miami, Florida, 33165

  • Chiesi Clinical Trial Site 840202

    Miami, Florida, 33166

  • Chiesi Clinical Trial Site 840275

    Miami, Florida, 33169

  • Chiesi Clinical Trial Site 840122

    Miami, Florida, 33173

  • Chiesi Clinical Trial Site 840352

    Miami, Florida, 33173

  • Chiesi Clinical Trial Site 840235

    Miami, Florida, 33174

  • Chiesi Clinical Trial Site 840360

    Miami, Florida, 33174

  • Chiesi Clinical Trial Site 840381

    Miami, Florida, 33174

  • Chiesi Clinical Trial Site 840243

    Miami, Florida, 33175

  • Chiesi Clinical Trial Site 840244

    Miami, Florida, 33175

  • Chiesi Clinical Trial Site 840257

    Miami, Florida, 33175

  • Chiesi Clinical Trial Site 840380

    Miami, Florida, 33175

  • Chiesi Clinical Trial Site 840382

    Miami, Florida, 33175

  • Chiesi Clinical Trial Site 840367

    Miami, Florida, 33176

  • Chiesi Clinical Trial Site 840162

    Miami, Florida, 33186

  • Chiesi Clinical Trial Site 840166

    Miami, Florida, 33186

  • Chiesi Clinical Trial Site 840370

    Miami, Florida, 33186

  • Chiesi Clinical Trial Site 840392

    Miami, Florida, 33186

  • Chiesi Clinical Trial Site 840319

    Miami Beach, Florida, 33141

  • Chiesi Clinical Trial Site 840328

    Miami Lakes, Florida, 33014

  • Chiesi Clinical Trial Site 840378

    Miami Lakes, Florida, 33014

  • Chiesi Clinical Trial Site 840288

    Miami Lakes, Florida, 33016

  • Chiesi Clinical Trial Site 840385

    Miami Lakes, Florida, 33016

  • Chiesi Clinical Trial Site 840353

    Miami Lakes, Florida, 33144

  • Chiesi Clinical Trial Site 840167

    Middleburg Heights, Ohio, 44130

  • Chiesi Clinical Trial Site 840273

    Missoula, Montana, 59808

  • Chiesi Clinical Trial Site 840433

    Mobile, Alabama, 36608

  • Chiesi Clinical Trial Site 840259

    Monroe, North Carolina, 28112

  • Chiesi Clinical Trial Site 840206

    Montgomery, Alabama, 36106

  • Chiesi Clinical Trial Site 840440

    Morgantown, North Carolina, 28655

  • Chiesi Clinical Trial Site 840201

    Morgantown, West Virginia, 26505

  • Chiesi Clinical Trial Site 840140

    Mt. Dora, Florida, 32757

  • Chiesi Clinical Trial Site 840249

    Muscle Shoals, Alabama, 35661

  • Chiesi Clinical Trial Site 840361

    Nashville, Tennessee, 37203

  • Chiesi Clinical Trial Site 840442

    Nederland, Texas, 77627

  • Chiesi Clinical Trial Site 840322

    New Bedford, Massachusetts, 02740

  • Chiesi Clinical Trial Site 840194

    New Bern, North Carolina, 28562

  • Chiesi Clinical Trial Site 840263

    New Port Richey, Florida, 34652

  • Chiesi Clinical Trial Site 840362

    New Windsor, New York, 12553

  • Chiesi Clinical Trial Site 840173

    Newport Beach, California, 92663

  • Chiesi Clinical Trial site 840250

    North Dartmouth, Massachusetts, 02747

  • Chiesi Clinical Trial Site 840132

    North Miami, Florida, 33161

  • Chiesi Clinical Trial Site 840161

    North Miami Beach, Florida, 33160

  • Chiesi Clinical Trial Site 840176

    North Richland Hills, Texas, 76180

  • Chiesi Clinical Trial Site 840208

    Northridge, California, 91324

  • Chiesi Clinical Trial Site 840277

    Northridge, California, 91324

  • Chiesi Clinical Trial Site 840399

    Norwalk, Connecticut, 06586

  • Chiesi Clinical Trial Site 840345

    Novi, Michigan, 48375

  • Chiesi Clinical Trial Site 840329

    Omaha, Nebraska, 68114

  • Chiesi Clinical Trial Site 840255

    Orlando, Florida, 32807

  • Chiesi Clinical Trial Site 840110

    Orlando, Florida, 32822

  • Chiesi Clinical Trial Site 840125

    Orlando, Florida, 32825

  • Chiesi Clinical Trial Site 840121

    Palmetto Bay, Florida, 33157

  • Chiesi Clinical Trial Site 840283

    Pearland, Texas, 77584

  • Chiesi Clinical Trial Site 840196

    Pembroke Pines, Florida, 33024

  • Chiesi Clinical Trial Site 840198

    Pembroke Pines, Florida, 33024

  • Chiesi Clinical Trial Site 840402

    Peoria, Arizona, 85381

  • Chiesi Clinical Trial Site 840327

    Pittsburgh, Pennsylvania, 15236

  • Chiesi Clinical Trial Site 840363

    Plantation, Florida, 33317

  • Chiesi Clinical Trial Site 840371

    Plantation, Florida, 33317

  • Chiesi Clinical Trial Site 840252

    Pompano Beach, Florida, 33064

  • Chiesi Clinical Trial Site 840105

    Port Charlotte, Florida, 33952

  • Chiesi Clinical Trial Site 840338

    Portsmouth, New Hampshire, 03810

  • Chiesi Clinical Trial Site 840120

    Raleigh, North Carolina, 27607

  • Chiesi Clinical Trial Site 840438

    Raleigh, North Carolina, 27607

  • Chiesi Clinical Trial Site 840429

    Raleigh, North Carolina, 27617

  • Chiesi Clinical Trial Site 840398

    Rapid City, South Dakota, 57702

  • Chiesi Clinical Trial Site 840364

    Redding, California, 96001

  • Chiesi Clinical Trial Site 840342

    Renton, Washington, 98055

  • Chiesi Clinical Trial Site 840159

    Richmond, Virginia, 23219

  • Chiesi Clinical Trial Site 840425

    Richmond, Virginia, 23226

  • Chiesi Clinical Trial Site 840316

    Richmond Heights, Missouri, 63117

  • Chiesi Clinical Trial Site 840448

    Ridgeland, Mississippi, 39157

  • Chiesi Clinical Trial Site 840138

    Rincon, Georgia, 31326

  • Chiesi Clinical Trial Site 840100

    Rock Hill, South Carolina, 29732

  • Chiesi Clinical Trial Site 840112

    Rocky Mount, North Carolina, 27804

  • Chiesi Clinical Trial Site 840226

    Sacramento, California, 95821

  • Chiesi Clinical Trial Site 840405

    Sacramento, California, 95823

  • Chiesi Clinical Trial Site 840150

    Saint Charles, Missouri, 63301

  • Chiesi Clinical Trial Site 840191

    San Antonio, Texas, 78063

  • Chiesi Clinical Trial Site 840320

    San Antonio, Texas, 78215

  • Chiesi Clinical Trial Site 840410

    San Antonio, Texas, 78229

  • Chiesi Clinical Trial Site 840107

    San Diego, California, 92120

  • Chiesi Clinical Trial Site 840373

    Santa Ana, California, 92705

  • Chiesi Clinical Trial Site 840294

    Sarasota, Florida, 34239

  • Chiesi Clinical Trial Site 840418

    Scotland, Pennsylvania, 15683

  • Chiesi Clinical Trial Site 840135

    Shelby, North Carolina, 28150

  • Chiesi Clinical Trial Site 840231

    Sherman, Texas, 75092

  • Chiesi Clinical Trial Site 840396

    Sherman, Texas, 75092

  • Chiesi Clinical Trial Site 840419

    Smithfield, Pennsylvania, 15478

  • Chiesi Clinical Trial Site 840287

    Southfield, Michigan, 48034

  • Chiesi Clinical Trial Site 840415

    Southfield, Michigan, 48075

  • Chiesi Clinical Trial Site 840375

    Spartanburg, South Carolina, 29303

  • Chiesi Clinical Trial Site 840394

    Splendora, Texas, 77372

  • Chiesi Clinical Trial Site 840282

    St Louis, Missouri, 63123

  • Chiesi Clinical Trial Site 840123

    St Louis, Missouri, 63141

  • Chiesi Clinical Trial Site 840142

    St Louis, Missouri, 63141

  • Chiesi Clinical Trial Site 840291

    St. Petersburg, Florida, 33704

  • Chiesi Clinical Trial Site 840417

    Stonecrest, Georgia, 30038

  • Chiesi Clinical Trial Site 840221

    Sugar Land, Texas, 77479

  • Chiesi Clinical Trial Site 840313

    Tampa, Florida, 33607

  • Chiesi Clinical Trial Site 840356

    Tampa, Florida, 33607

  • Chiesi Clinical Trial Site 840379

    Tampa, Florida, 33607

  • Chiesi Clinical Trial Site 840131

    Tampa, Florida, 33613

  • Chiesi Clinical Trial Site 840324

    Tampa, Florida, 33614

  • Chiesi Clinical Trial Site 840309

    Tampa, Florida, 33634

  • Chiesi Clinical Trial Site 840128

    The Bronx, New York, 10455

  • Chiesi Clinical Trial Site 840210

    The Villages, Florida, 32162

  • Chiesi Clinical Trial Site 840157

    Toledo, Ohio, 43617

  • Chiesi Clinical Trial Site 840139

    Tomball, Texas, 77375

  • Chiesi Clinical Trial Site 840314

    Tomball, Texas, 77375

  • Chiesi Clinical Trial Site 840333

    Toms River, New Jersey, 08755

  • Chiesi Clinical Trial Site 840349

    Tucson, Arizona, 85741

  • Chiesi Clinical Trial Site 840271

    Tullahoma, Tennessee, 37388

  • Chiesi Clinical Trial Site 840106

    Union, South Carolina, 29379

  • Chiesi Clinical Trial Site 840383

    Union City, Georgia, 30291

  • Chiesi Clinical Trial Site 840164

    Upland, California, 91786

  • Chiesi Clinical Trial Site 840108

    Valparaiso, Indiana, 76383

  • Chiesi Clinical Trial Site 840154

    Vancouver, Washington, 98664

  • Chiesi Clinical Trial Site 840295

    West Columbia, South Carolina, 29169

  • Chiesi Clinical Trial Site 840174

    West Covina, California, 91790

  • Chiesi Clinical Trial Site 840144

    Westminster, California, 92683

  • Chiesi Clinical Trial Site 840199

    Westminster, Maryland, 21157

  • Chiesi Clinical Trial Site 840189

    Wilmington, North Carolina, 28403

  • Chiesi Clinical Trial Site 840412

    Winston-Salem, North Carolina, 27103

  • Chiesi Clinical Trial Site 840129

    Winter Park, Florida, 32789

  • Chiesi Clinical Trial Site 840436

    Zachary, Louisiana, 70791

Other trials in United States

Argentina35 sites

  • Chiesi Clinical Trial Site 032125

    Buenos Aires, 1407

  • Chiesi Clinical Trial Site 032130

    Buenos Aires, C1425FVH

  • Chiesi Clinical Trial Site 032133

    Buenos Aires

  • Chiesi Clinical Trial Site 032115

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1056ABJ

  • Chiesi Clinical Trial Site 032113

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1426

  • Chiesi Clinical Trial Site 032107

    Ciudad Autonoma de Buenos Aire, Buenos Aires, B1837

  • Chiesi Clinical Trial Site 032112

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1426ABO

  • Chiesi Clinical Trial Site 032121

    Ciudad Autonoma de Buenos Aire, Buenos Aires, Cl425DTG

  • Chiesi Clinical Trial Site 032103

    Ciudad Autonoma de Buenos Aire, 1430

  • Chiesi Clinical Trial Site 032109

    Ciudad Autonoma de Buenos Aire, B1602DOH

  • Chiesi Clinical Trial Site 032120

    Concepción del Uruguay, Entre Ríos Province, E3260EPD

  • Chiesi Clinical Trial Site 032111

    Córdoba, Córdoba Province, X5008HHW

  • Chiesi Clinical Trial Site 032122

    Córdoba, 5000

  • Chiesi Clinical Trial Site 032108

    La Plata, Buenos Aires, 1900

  • Chiesi Clinical Trial Site 032131

    Lobos, 7240

  • Chiesi Clinical Trial Site 032118

    Mar del Plata, Buenos Aires, 3168

  • Chiesi Clinical Trial Site 032114

    Mar del Plata, Buenos Aires, B7600FZO

  • Chiesi Clinical Trial Site 032119

    Mar del Plata, 7600

  • Chiesi Clinical Trial Site 032105

    Mendoza, 5500

  • Chiesi Clinical Trial Site 032129

    Mendoza, 5500

  • Chiesi Clinical Trial Site 032126

    Mendoza, M5502IDE

  • Chiesi Clinical Trial Site 032102

    Monte Grande, Buenos Aires, 1842

  • Chiesi Clinical Trial Site 032123

    Paraná, 3100

  • Chiesi Clinical Trial Site 032106

    Quilmes, Buenos Aires, B1878FNR

  • Chiesi Clinical Trial Site 032101

    Rosario, Santa Fe Province, 2000

  • Chiesi Clinical Trial Site 032132

    Rosario, Santa Fe Province, S2121

  • Chiesi Clinical Trial Site 032128

    Rosario, S2002OJN

  • Chiesi Clinical Trial Site 032116

    San Fernando, Buenos Aires, 1646

  • Chiesi Clinical Trial Site 032110

    San Juan Bautista, Buenos Aires, B1853AIK

  • Chiesi Clinical Trial Site 032117

    San Miguel de Tucumán, Tucumán Province, T4000

  • Chiesi Clinical Trial Site 032134

    San Miguel de Tucumán, 4000

  • Chiesi Clinical Trial Site 032136

    San Miguel de Tucumán, 4000

  • Chiesi Clinical Trial Site 032127

    San Rafael, 5600

  • Chiesi Clinical Trial Site 032124

    Santa Fe, 3000

  • Chiesi Clinical Trial Site 032100

    Vicente López, Buenos Aires, 1602

Other trials in Argentina

Bulgaria30 sites

  • Chiesi Clinical Trial Site 100125

    Gabrovo

  • Chiesi Clinical Trial Site 100109

    Haskovo

  • Chiesi Clinical Trial Site 100129

    Kozloduy, 3320

  • Chiesi Clinical Trial Site 100111

    Lovech

  • Chiesi Clinical Trial Site 100115

    Montana

  • Chiesi Clinical Trial Site 100132

    Pleven, 5808

  • Chiesi Clinical Trial Site 100101

    Pleven

  • Chiesi Clinical Trial Site 100131

    Plovdiv, 4003

  • Chiesi Clinical Trial Site 100102

    Plovdiv

  • Chiesi Clinical Trial Site 100126

    Plovdiv

  • Chiesi Clinical Trial Site 100128

    Razgrad, 7200

  • Chiesi Clinical Trial Site 100104

    Rousse

  • Chiesi Clinical Trial Site 100113

    Rousse

  • Chiesi Clinical Trial Site 100100

    Sofia

  • Chiesi Clinical Trial Site 100110

    Sofia

  • Chiesi Clinical Trial Site 100112

    Sofia

  • Chiesi Clinical Trial Site 100116

    Sofia

  • Chiesi Clinical Trial Site 100117

    Sofia

  • Chiesi Clinical Trial Site 100118

    Sofia

  • Chiesi Clinical Trial Site 100119

    Sofia

  • Chiesi Clinical Trial Site 100121

    Sofia

  • Chiesi Clinical Trial Site 100123

    Sofia

  • Chiesi Clinical Trial Site 100124

    Sofia

  • Chiesi Clinical Trial Site 100127

    Sofia

  • Chiesi Clinical Trial Site 100103

    Stara Zagora

  • Chiesi Clinical Trial Site 100107

    Stara Zagora

  • Chiesi Clinical Trial Site 100130

    Varna, 9020

  • Chiesi Clinical Trial Site 100122

    Veliko Tarnovo

  • Chiesi Clinical Trial Site 100106

    Vidin

  • Chiesi Clinical Trial Site 100114

    Vidin

Other trials in Bulgaria

Poland27 sites

  • Chiesi Clinical Trial Site 616125

    Bialystok, 15-003

  • Chiesi Clinical Trial Site 616119

    Bialystok

  • Chiesi Clinical Trial Site 616100

    Giżycko

  • Chiesi Clinical Trial Site 616113

    Grudziądz

  • Chiesi Clinical Trial Site 616116

    Katowice

  • Chiesi Clinical Trial Site 616122

    Krakow, 30-149

  • Chiesi Clinical Trial Site 616106

    Krakow

  • Chiesi Clinical Trial Site 616109

    Krakow

  • Chiesi Clinical Trial Site 616118

    Krakow

  • Chiesi Clinical Trial Site 616103

    Lodz

  • Chiesi Clinical Trial Site 616128

    Olsztyn

  • Chiesi Clinical Trial Site 616105

    Ostróda

  • Chiesi Clinical Trial Site 616117

    Ostrowiec

  • Chiesi Clinical Trial Site 616123

    Poznan, 60-214

  • Chiesi Clinical Trial Site 616107

    Poznan

  • Chiesi Clinical Trial Site 616110

    Poznan

  • Chiesi Clinical Trial Site 616108

    Rzeszów

  • Chiesi Clinical Trial Site 616114

    Skierniewice

  • Chiesi Clinical Trial Site 616120

    Skorzewo, 60-185

  • Chiesi Clinical Trial Site 616102

    Sosnowiec

  • Chiesi Clinical Trial Site 616111

    Tarnów

  • Chiesi Clinical Trial Site 616115

    Torun

  • Chiesi Clinical Trial Site 616127

    Warsaw, 00-215

  • Chiesi Clinical Trial Site 616126

    Wroclaw, 54-239

  • Chiesi Clinical Trial Site 616104

    Wroclaw

  • Chiesi Clinical Trial Site 616112

    Wroclaw

  • Chiesi Clinical Trial Site 616101

    Zawadzkie

Other trials in Poland

Romania20 sites

  • Chiesi Clinical Trial Site 642109

    Bacau, 600252

  • Chiesi Clinical Trial Site 642107

    Bragadiru, Ilfov, 077025

  • Chiesi Clinical Trial Site 642106

    Bragadiru, 077025

  • Chiesi Clinical Trial Site 642117

    Brasov, 500283

  • Chiesi Clinical Trial Site 642108

    Bucharest, 012071

  • Chiesi Clinical Trial Site 642103

    Bucharest, 020125

  • Chiesi Clinical Trial Site 642113

    Bucharest, 11025

  • Chiesi Clinical Trial Site 642115

    Caracal, 235200

  • Chiesi Clinical Trial Site 642104

    Cluj-Napoca, Cluj, 400371

  • Chiesi Clinical Trial Site 642111

    Cluj-Napoca, 400275

  • Chiesi Clinical Trial Site 642105

    Constanța, 900433

  • Chiesi Clinical Trial Site 642110

    Craiova, 200515

  • Chiesi Clinical Trial Site 642118

    Craiova, 200515

  • Chiesi Clinical Trial Site 642120

    Deva, Hunedoara County, 330162

  • Chiesi Clinical Trial Site 642101

    Iași, 700141

  • Chiesi Clinical Trial Site 642102

    Oradea, Bihor County, 410169

  • Chiesi Clinical Trial Site 642114

    Reșca, 237143

  • Chiesi Clinical Trial Site 642112

    Satu Mare, 44055

  • Chiesi Clinical Trial Site 642119

    Timișoara, Timiș County, 300336

  • Chiesi Clinical Trial Site 642116

    Timișoara, 300134

Other trials in Romania

Mexico16 sites

  • Chiesi Clinical Trial Site 484116

    Chihuahua City, 31217

  • Chiesi Clinical Trial Site 484105

    Chihuahua City

  • Chiesi Clinical Trial Site 484109

    Chihuahua City

  • Chiesi Clinical Trial Site 484103

    Cuauhtémoc, Mexico City

  • Chiesi Clinical Trial Site 484113

    Guadalajara, Jalisco, 44610

  • Chiesi Clinical Trial Site 484100

    Guadalajara, Jalisco

  • Chiesi Clinical Trial Site 484102

    Guadalajara, Jalisco

  • Chiesi Clinical Trial Site 484104

    Guadalajara, Jalisco

  • Chiesi Clinical Trial Site 484106

    Guadalajara, Jalisco

  • Chiesi Clinical Trial Site 484112

    Guadalajara, Jalisco

  • Chiesi Clinical Trial Site 484115

    Guadalupe, Jalisco, 44200

  • Chiesi Clinical Trial Site 484101

    Monterrey, Nuevo León

  • Chiesi Clinical Trial Site 484111

    Monterrey, Nuevo León

  • Chiesi Clinical Trial Site 484107

    Morelia, Michoacán

  • Chiesi Clinical Trial Site 484110

    Tijuana, Estado de Baja California

  • Chiesi Clinical Trial Site 484108

    Tlalpan

Other trials in Mexico

Hungary14 sites

  • Chiesi Clinical Trial Site 348107

    Balassagyarmat, Nógrád megye

  • Chiesi Clinical Trial Site 348124

    Csorna, GS, 9300

  • Chiesi Clinical Trial Site 348118

    Debrecen

  • Chiesi Clinical Trial Site 348120

    Gödöllő, Pest County

  • Chiesi Clinical Trial Site 348112

    Hajdúnánás

  • Chiesi Clinical Trial Site 348116

    Hatvan

  • Chiesi Clinical Trial Site 348121

    Komló, BA, 7300

  • Chiesi Clinical Trial Site 348103

    Monor

  • Chiesi Clinical Trial Site 348104

    Nyíregyháza, Szabolcs-Szatmár-Bereg

  • Chiesi Clinical Trial Site 348109

    Nyíregyháza, Szabolcs-Szatmár-Bereg

  • Chiesi Clinical Trial Site 348122

    Pécs, BA, 7626

  • Chiesi Clinical Trial Site 348125

    Sellye, 7960

  • Chiesi Clinical Trial Site 348126

    Szolnok, JN, 5000

  • Chiesi Clinical Trial Site 348105

    Szombathely, Vas County

Other trials in Hungary

Czechia11 sites

  • Chiesi Clinical Trial Site 203101

    Brandýs nad Labem

  • Chiesi Clinical Trial Site 203107

    Jindřichův Hradec

  • Chiesi Clinical Trial Site 203109

    Miroslav

  • Chiesi Clinical Trial Site 203116

    Prague, 11000

  • Chiesi Clinical Trial Site 203115

    Prague, 140 00

  • Chiesi Clinical Trial Site 203114

    Prague

  • Chiesi Clinical Trial Site 203112

    Rokycany

  • Chiesi Clinical Trial Site 203108

    Strakonice

  • Chiesi Clinical Trial Site 203105

    Tábor

  • Chiesi Clinical Trial Site 203104

    Teplice

  • Chiesi Clinical Trial Site 203110

    Varnsdorf

Other trials in Czechia

Canada6 sites

  • Chiesi Clinical Trial Site 124102

    Burlington, Ontario, L7N 3V2

  • Chiesi Clinical Trial Site 124103

    Edmonton, Alberta, T5A 4L8

  • Chiesi Clinical Trial Site 124104

    Greater Sudbury, Ontario, P3C 1X3

  • Chiesi Clinical Trial Site 124105

    Sherwood Park, Alberta, T8H 0N2

  • Chiesi Clinical Trial Site 124106

    Trois-Rivières, Quebec, G8T 7A1

  • Chiesi Clinical Trial Site 124100

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Puerto Rico1 site

  • Chiesi Clinical Trial Site 840393

    Guaynabo, 00968

Other trials in Puerto Rico

About this study

Official title: A Phase III, 52-week, Multinational, Multicenter, Randomized, Double-blind, 2-arm Parallel Group Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide (CHF 5993) With the Fixed Dose Dual Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate (CHF 1535), Both Administered Via pMDI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes in the target subject population.

Read the detailed description

This is a phase III, multinational, multicenter, randomized, double-blind active controlled 2-arm parallel group study to compare efficacy, safety, and tolerability of CHF 5993 pMDI with CHF 1535 pMDI with respect to lung function, incidence of moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes.

After screening, eligible subjects will enter 2-week run-in period using their regular COPD maintenance therapies after which they will be randomized to one of 2 study treatment groups. Following randomization, subjects will be assessed after 4 weeks then at 6-week intervals thereafter for a period of 52 weeks. A follow-up safety phone call will be performed a week after the last clinic visit. A subset of subjects consenting to participate in the pharmacokinetic substudy will undergo additional assessments (totaling 3 visits) during the scheduled study visits.

During the study, daily symptoms, rescue medication use and compliance with the study drug will be recorded via a subject electronic diary. Subject concomitant medications, adverse events, and healthcare resource utilization will be assessed and recorded throughout the study. At intermittent study visits, subjects will undergo vital signs examinations including weight, spirometry measurements, and 12-lead ECG. Symptoms and COPD health status will be assessed through disease specific questionnaires. Routine hematology, blood chemistry, and serum pregnancy testing will be performed before enrollment and at end of study.

Being tested
Beclomethasone Dipropionate, Glycopyrronium Bromide, Formoterol Fumarate
Keywords
Lung Function, Safety Profile, Beclomethasone Dipropionate, Glycopyrronium Bromide, Formoterol Fumarate
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

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

  • Beclomethasone DipropionateDrug

    Also called BDP

    Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg

  • Glycopyrronium BromideDrug

    Also called glycopyrrolate, GB

    Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg

  • Formoterol FumarateDrug

    Also called FF

    Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg

Study groups in NCT04320342
Study groupRoleWhat they receive
BDP/FF/GB - CHF 5993ExperimentalTwo inhalations twice daily of BDP/FF/GB (100/6/12.5μg) for a period of 52 weeks via pressurized metered dose inhaler
Receives: Drug: Beclomethasone Dipropionate; Drug: Glycopyrronium Bromide; Drug: Formoterol Fumarate
BDP/FF - CHF 1535Active comparatorTwo inhalations twice daily of BDP/FF (100/6μg) for a period of 52 weeks via pressurized metered dose inhaler
Receives: Drug: Beclomethasone Dipropionate; Drug: Formoterol Fumarate

What is being measured

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

  1. Change from baseline in pre-dose morning Forced Expiratory Volume in the 1st second (FEV1) at Week 28

    Measured: Week 28

Secondary outcomes (21)

  1. Change from baseline in 2-hour post-dose morning FEV1 at Week 28

    Measured: Week 28

  2. Rate of moderate and severe COPD exacerbations over 52 weeks of treatment

    Annualized rate of moderate and severe COPD exacerbations as observed during the 52-week study treatment period.

    Measured: 52-week treatment period

  3. Change from baseline in pre-dose morning FEV1 at designated clinic visits

    Measured: Week 4, Week 10, Week 40, & Week 52

  4. Change from baseline in 2-hour post-dose morning FEV1 designated clinic visits

    Measured: Day 1, Week 4, Week 10, Week 40, & Week 52

  5. Change from pre-dose to 2-hour post-dose morning FEV1 at designated clinic visits

    Measured: Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52

  6. FEV1 response (change from baseline in pre-dose morning FEV1 ≥100ml) at designated clinic visits

    Measured: Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52

  7. Time to first moderate or severe COPD exacerbation

    Measured: 52-week treatment period

  8. Rate of severe COPD exacerbations over 52 weeks of treatment

    Annualized rate of severe COPD exacerbations as observed during 52-week treatment period

    Measured: 52-week treatment period

  9. Time to first severe COPD exacerbation

    Measured: 52-week treatment period

  10. Saint George's Respiratory Questionnaire (SGRQ) response (a decrease from baseline in total score ≥4) at designated clinic visits

    Measured: Week 4, Week 10, Week 28, Week 40, & Week 52

  11. Change from baseline in the SGRQ total score and domain scores at each designated clinic visit

    Measured: Week 4, Week 10, Week 28, Week 40, & Week 52

  12. Change from baseline to each inter-visit period in the percentage of days without intake of rescue medication

    Change from baseline (defined as the 2-week run-in period prior to randomization) to each inter-visit period (defined as the period of time between designated clinic visits) in percentage of days without rescue medication

    Measured: Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52

  13. Change from baseline to each inter-visit period in the average use of rescue medication (number of puffs/day)

    Change from baseline (defined as the 2-week run-in period prior to randomization) in the average number of puffs per day of rescue medication for each inter-visit period (defined as the period of time between designated clinic visits).

    Measured: Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52

  14. Change from baseline in pre-dose morning Forced Vital Capacity (FVC) at designated clinic visits

    Measured: Week 4, Week 10, Week 28, Week 40, & Week 52

  15. Change from baseline in 2-hour post-dose morning FVC at designated clinic visits

    Change from baseline (defined as the pre-dose value on Day 1) in 2-hour post-dose morning FVC at designated clinic visits

    Measured: Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52

  16. Change from pre-dose to 2-hour post-dose morning FVC at designated clinic visits

    Measured: Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52

  17. Change from baseline to each inter-visit period in the average E-RS total score and domain scores

    Change from baseline (defined as the 2-week run-in period prior to randomization) in the average E-RS total score and E-RS domain scores for the period of time between designated clinic visits.

    Measured: Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52

  18. Change from baseline in COPD Assessment Test (CAT) score at designated clinic visit

    The CAT is composed of 8 questions to measure the impact of COPD on daily life, which are scored from 0 to 5 with higher scores reflecting greater impact.

    Measured: Week 4, Week 10, Week 28, Week 40, & Week 52

  19. CAT response (decrease from baseline ≥2 points) at designated clinic visits

    Measured: Week 4, Week 10, Week 28, Week 40, & Week 52

  20. Modified Medical Research Council (mMRC) dyspnea scale at designated clinic visits

    Descriptive statistics of the mMRC dyspnea scale score at designated clinic visits. The mMRC dyspnea scale is graded from 0 to 4, with higher grades reflecting greater severity.

    Measured: Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52

  21. Change from baseline in health-related quality of life (decrease from baseline in total SGRQ score ≥4) over 52 weeks of treatment.

    Measured: 52-week treatment period

Timeline

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

  1. First posted25 Mar 2020
  2. Study start27 Apr 2022
  3. Primary completion12 Jan 2026
  4. Study completion12 Jan 2026

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
3,406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04320342
Sponsor's protocol ID
CLI-05993AA3-06
Other IDs
2020-002389-16, 2023-510172-31-00, 2023
Acronym
TRITON
Status last verified
Sep 2026
First submitted
23 Mar 2020
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.

    PubMed 22743675

  • Lopez AD, Shibuya K, Rao C, Mathers CD, Hansell AL, Held LS, Schmid V, Buist S. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J. 2006 Feb;27(2):397-412. doi: 10.1183/09031936.06.00025805. No abstract available.

    PubMed 16452599

  • Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Barker-Collo S, Bartels DH, Bell ML, Benjamin EJ, Bennett D, Bhalla K, Bikbov B, Bin Abdulhak A, Birbeck G, Blyth F, Bolliger I, Boufous S, Bucello C, Burch M, Burney P, Carapetis J, Chen H, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahodwala N, De Leo D, Degenhardt L, Delossantos A, Denenberg J, Des Jarlais DC, Dharmaratne SD, Dorsey ER, Driscoll T, Duber H, Ebel B, Erwin PJ, Espindola P, Ezzati M, Feigin V, Flaxman AD, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabriel SE, Gakidou E, Gaspari F, Gillum RF, Gonzalez-Medina D, Halasa YA, Haring D, Harrison JE, Havmoeller R, Hay RJ, Hoen B, Hotez PJ, Hoy D, Jacobsen KH, James SL, Jasrasaria R, Jayaraman S, Johns N, Karthikeyan G, Kassebaum N, Keren A, Khoo JP, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lipnick M, Lipshultz SE, Ohno SL, Mabweijano J, MacIntyre MF, Mallinger L, March L, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGrath J, Mensah GA, Merriman TR, Michaud C, Miller M, Miller TR, Mock C, Mocumbi AO, Mokdad AA, Moran A, Mulholland K, Nair MN, Naldi L, Narayan KM, Nasseri K, Norman P, O'Donnell M, Omer SB, Ortblad K, Osborne R, Ozgediz D, Pahari B, Pandian JD, Rivero AP, Padilla RP, Perez-Ruiz F, Perico N, Phillips D, Pierce K, Pope CA 3rd, Porrini E, Pourmalek F, Raju M, Ranganathan D, Rehm JT, Rein DB, Remuzzi G, Rivara FP, Roberts T, De Leon FR, Rosenfeld LC, Rushton L, Sacco RL, Salomon JA, Sampson U, Sanman E, Schwebel DC, Segui-Gomez M, Shepard DS, Singh D, Singleton J, Sliwa K, Smith E, Steer A, Taylor JA, Thomas B, Tleyjeh IM, Towbin JA, Truelsen T, Undurraga EA, Venketasubramanian N, Vijayakumar L, Vos T, Wagner GR, Wang M, Wang W, Watt K, Weinstock MA, Weintraub R, Wilkinson JD, Woolf AD, Wulf S, Yeh PH, Yip P, Zabetian A, Zheng ZJ, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2095-128. doi: 10.1016/S0140-6736(12)61728-0.

    PubMed 23245604

  • Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.

    PubMed 17132052

  • Montes de Oca M, Perez-Padilla R, Talamo C, Halbert RJ, Moreno D, Lopez MV, Muino A, Jose Roberto BJ, Valdivia G, Pertuze J, Ana Maria BM; PLATINO Team. Acute bronchodilator responsiveness in subjects with and without airflow obstruction in five Latin American cities: the PLATINO study. Pulm Pharmacol Ther. 2010 Feb;23(1):29-35. doi: 10.1016/j.pupt.2009.09.005. Epub 2009 Oct 8.

    PubMed 19818867

  • Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.

    PubMed 10377201

  • Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.

    PubMed 19720809

  • Lane DC, Stemkowski S, Stanford RH, Tao Z. Initiation of Triple Therapy with Multiple Inhalers in Chronic Obstructive Pulmonary Disease: An Analysis of Treatment Patterns from a U.S. Retrospective Database Study. J Manag Care Spec Pharm. 2018 Nov;24(11):1165-1172. doi: 10.18553/jmcp.2018.24.11.1165.

    PubMed 30362922

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Beclomethasone Dipropionate, Glycopyrronium Bromide and Formoterol Fumarate in people with COPD and COPD Exacerbation, run by Chiesi Farmaceutici S.p.A. at 436 sites in 10 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 14 inclusion and 31 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 436 sites in United States, Argentina, Bulgaria, Poland, Romania and 5 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline in pre-dose morning Forced Expiratory Volume in the 1st second (FEV1) at Week 28 (time frame: Week 28). 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 NCT04320342, which also lists 33 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 21 Sep 2026.

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TRITON Clinical Trial NCT04320342 | AzTrials