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
TRITON
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)
2 other identifiers
interventional
3,433
10 countries
436
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2022
Typical duration for phase_3
436 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedStudy Start
First participant enrolled
April 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2026
CompletedJanuary 30, 2026
January 1, 2026
3.7 years
March 23, 2020
January 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in pre-dose morning Forced Expiratory Volume in the 1st second (FEV1) at Week 28
Week 28
Secondary Outcomes (21)
Change from baseline in 2-hour post-dose morning FEV1 at Week 28
Week 28
Rate of moderate and severe COPD exacerbations over 52 weeks of treatment
52-week treatment period
Change from baseline in pre-dose morning FEV1 at designated clinic visits
Week 4, Week 10, Week 40, & Week 52
Change from baseline in 2-hour post-dose morning FEV1 designated clinic visits
Day 1, Week 4, Week 10, Week 40, & Week 52
Change from pre-dose to 2-hour post-dose morning FEV1 at designated clinic visits
Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52
- +16 more secondary outcomes
Study Arms (2)
BDP/FF/GB - CHF 5993
EXPERIMENTALTwo inhalations twice daily of BDP/FF/GB (100/6/12.5μg) for a period of 52 weeks via pressurized metered dose inhaler
BDP/FF - CHF 1535
ACTIVE COMPARATORTwo inhalations twice daily of BDP/FF (100/6μg) for a period of 52 weeks via pressurized metered dose inhaler
Interventions
Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg
Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg
Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg
Eligibility Criteria
You may qualify if:
- 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)
- 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.
You may not qualify if:
- 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
- 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:
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (436)
Chiesi Clinical Trial Site 840350
Birmingham, Alabama, 35215-7502, United States
Chiesi Clinical Trial Site 840186
Dothan, Alabama, 36303, United States
Chiesi Clinical Trial Site 840258
Foley, Alabama, 36535, United States
Chiesi Clinical Trial Site 840279
Jasper, Alabama, 35501, United States
Chiesi Clinical Trial Site 840433
Mobile, Alabama, 36608, United States
Chiesi Clinical Trial Site 840206
Montgomery, Alabama, 36106, United States
Chiesi Clinical Trial Site 840249
Muscle Shoals, Alabama, 35661, United States
Chiesi Clinical Trial Site 840406
Chandler, Arizona, 85224, United States
Chiesi Clinical Trial Site 840402
Peoria, Arizona, 85381, United States
Chiesi Clinical Trial Site 840349
Tucson, Arizona, 85741, United States
Chiesi Clinical Trial Site 840404
Covina, California, 91723, United States
Chiesi Clinical Trial Site 840209
Escondido, California, 92025, United States
Chiesi Clinical Trial Site 840427
La Palma, California, 90623, United States
Chiesi Clinical Trial Site 840358
Lomita, California, 90717, United States
Chiesi Clinical Trial Site 840173
Newport Beach, California, 92663, United States
Chiesi Clinical Trial Site 840208
Northridge, California, 91324, United States
Chiesi Clinical Trial Site 840277
Northridge, California, 91324, United States
Chiesi Clinical Trial Site 840364
Redding, California, 96001, United States
Chiesi Clinical Trial Site 840226
Sacramento, California, 95821, United States
Chiesi Clinical Trial Site 840405
Sacramento, California, 95823, United States
Chiesi Clinical Trial Site 840107
San Diego, California, 92120, United States
Chiesi Clinical Trial Site 840373
Santa Ana, California, 92705, United States
Chiesi Clinical Trial Site 840164
Upland, California, 91786, United States
Chiesi Clinical Trial Site 840174
West Covina, California, 91790, United States
Chiesi Clinical Trial Site 840144
Westminster, California, 92683, United States
Chiesi Clinical Trial Site 840441
Aurora, Colorado, 80014, United States
Chiesi Clinical Trial Site 840229
Boulder, Colorado, 80302, United States
Chiesi Clinical Trial Site 840399
Norwalk, Connecticut, 06586, United States
Chiesi Clinical Trial Site 840116
Altamonte Springs, Florida, 32701, United States
Chiesi Clinical Trial Site 840268
Aventura, Florida, 33180, United States
Chiesi Clinical Trial Site 840192
Brandon, Florida, 33511, United States
Chiesi Clinical Trial Site 840310
Brooksville, Florida, 34613, United States
Chiesi Clinical Trial Site 840240
Chiefland, Florida, 32626, United States
Chiesi Clinical Trial Site 840153
Clearwater, Florida, 33756, United States
Chiesi Clinical Trial Site 840272
Coral Gables, Florida, 33134, United States
Chiesi Clinical Trial Site 840304
Coral Gables, Florida, 33134, United States
Chiesi Clinical Trial Site 840193
Cutler Bay, Florida, 33157, United States
Chiesi Clinical Trial Site 840311
Cutler Bay, Florida, 33189, United States
Chiesi Clinical Trial Site 840335
Cutler Bay, Florida, 33189, United States
Chiesi Clinical Trial Site 840141
Daytona Beach, Florida, 32117, United States
Chiesi Clinical Trial Site 840133
DeLand, Florida, 32720, United States
Chiesi Clinical Trial Site 840269
Doral, Florida, 33122, United States
Chiesi Clinical Trial Site 840303
Hialeah, Florida, 33010, United States
Chiesi Clinical Trial Site 840163
Hialeah, Florida, 33012, United States
Chiesi Clinical Trial Site 840165
Hialeah, Florida, 33012, United States
Chiesi Clinical Trial Site 840238
Hialeah, Florida, 33012, United States
Chiesi Clinical Trial Site 840265
Hialeah, Florida, 33012, United States
Chiesi Clinical Trial Site 840241
Hialeah, Florida, 33015, United States
Chiesi Clinical Trial Site 840253
Hialeah, Florida, 33015, United States
Chiesi Clinical Trial Site 840184
Hialeah, Florida, 33016, United States
Chiesi Clinical Trial Site 840267
Hialeah, Florida, 33016, United States
Chiesi Clinical Trial Site 840354
Hialeah Gardens, Florida, 33016, United States
Chiesi Clinical Trial Site 840256
Hialeah Gardens, Florida, 33066, United States
Chiesi Clinical Trial Site 840200
Kissimmee, Florida, 34741, United States
Chiesi Clinical Trial Site 840232
Lakeland, Florida, 33803, United States
Chiesi Clinical Trial Site 840113
Leesburg, Florida, 34748, United States
Chiesi Clinical Trial Site 840372
Miami, Florida, 33122, United States
Chiesi Clinical Trial Site 840137
Miami, Florida, 33125, United States
Chiesi Clinical Trial Site 840289
Miami, Florida, 33125, United States
Chiesi Clinical Trial Site 840377
Miami, Florida, 33125, United States
Chiesi Clinical Trial Site 840387
Miami, Florida, 33125, United States
Chiesi Clinical Trial Site 840326
Miami, Florida, 33126, United States
Chiesi Clinical Trial Site 840175
Miami, Florida, 33133, United States
Chiesi Clinical Trial Site 840346
Miami, Florida, 33133, United States
Chiesi Clinical Trial Site 840347
Miami, Florida, 33134, United States
Chiesi Clinical Trial Site 840205
Miami, Florida, 33135, United States
Chiesi Clinical Trial Site 840247
Miami, Florida, 33135, United States
Chiesi Clinical Trial Site 840341
Miami, Florida, 33135, United States
Chiesi Clinical Trial Site 840148
Miami, Florida, 33144, United States
Chiesi Clinical Trial Site 840239
Miami, Florida, 33144, United States
Chiesi Clinical Trial Site 840312
Miami, Florida, 33144, United States
Chiesi Clinical Trial Site 840355
Miami, Florida, 33144, United States
Chiesi Clinical Trial Site 840388
Miami, Florida, 33144, United States
Chiesi Clinical Trial Site 840237
Miami, Florida, 33155, United States
Chiesi Clinical Trial Site 840261
Miami, Florida, 33155, United States
Chiesi Clinical Trial Site 840262
Miami, Florida, 33155, United States
Chiesi Clinical Trial Site 840280
Miami, Florida, 33155, United States
Chiesi Clinical Trial Site 840178
Miami, Florida, 33165, United States
Chiesi Clinical Trial Site 840292
Miami, Florida, 33165, United States
Chiesi Clinical Trial Site 840202
Miami, Florida, 33166, United States
Chiesi Clinical Trial Site 840275
Miami, Florida, 33169, United States
Chiesi Clinical Trial Site 840122
Miami, Florida, 33173, United States
Chiesi Clinical Trial Site 840352
Miami, Florida, 33173, United States
Chiesi Clinical Trial Site 840235
Miami, Florida, 33174, United States
Chiesi Clinical Trial Site 840360
Miami, Florida, 33174, United States
Chiesi Clinical Trial Site 840381
Miami, Florida, 33174, United States
Chiesi Clinical Trial Site 840243
Miami, Florida, 33175, United States
Chiesi Clinical Trial Site 840244
Miami, Florida, 33175, United States
Chiesi Clinical Trial Site 840257
Miami, Florida, 33175, United States
Chiesi Clinical Trial Site 840380
Miami, Florida, 33175, United States
Chiesi Clinical Trial Site 840382
Miami, Florida, 33175, United States
Chiesi Clinical Trial Site 840367
Miami, Florida, 33176, United States
Chiesi Clinical Trial Site 840162
Miami, Florida, 33186, United States
Chiesi Clinical Trial Site 840166
Miami, Florida, 33186, United States
Chiesi Clinical Trial Site 840370
Miami, Florida, 33186, United States
Chiesi Clinical Trial Site 840392
Miami, Florida, 33186, United States
Chiesi Clinical Trial Site 840319
Miami Beach, Florida, 33141, United States
Chiesi Clinical Trial Site 840328
Miami Lakes, Florida, 33014, United States
Chiesi Clinical Trial Site 840378
Miami Lakes, Florida, 33014, United States
Chiesi Clinical Trial Site 840288
Miami Lakes, Florida, 33016, United States
Chiesi Clinical Trial Site 840385
Miami Lakes, Florida, 33016, United States
Chiesi Clinical Trial Site 840353
Miami Lakes, Florida, 33144, United States
Chiesi Clinical Trial Site 840140
Mt. Dora, Florida, 32757, United States
Chiesi Clinical Trial Site 840263
New Port Richey, Florida, 34652, United States
Chiesi Clinical Trial Site 840132
North Miami, Florida, 33161, United States
Chiesi Clinical Trial Site 840161
North Miami Beach, Florida, 33160, United States
Chiesi Clinical Trial Site 840255
Orlando, Florida, 32807, United States
Chiesi Clinical Trial Site 840110
Orlando, Florida, 32822, United States
Chiesi Clinical Trial Site 840125
Orlando, Florida, 32825, United States
Chiesi Clinical Trial Site 840121
Palmetto Bay, Florida, 33157, United States
Chiesi Clinical Trial Site 840196
Pembroke Pines, Florida, 33024, United States
Chiesi Clinical Trial Site 840198
Pembroke Pines, Florida, 33024, United States
Chiesi Clinical Trial Site 840363
Plantation, Florida, 33317, United States
Chiesi Clinical Trial Site 840371
Plantation, Florida, 33317, United States
Chiesi Clinical Trial Site 840252
Pompano Beach, Florida, 33064, United States
Chiesi Clinical Trial Site 840105
Port Charlotte, Florida, 33952, United States
Chiesi Clinical Trial Site 840294
Sarasota, Florida, 34239, United States
Chiesi Clinical Trial Site 840291
St. Petersburg, Florida, 33704, United States
Chiesi Clinical Trial Site 840313
Tampa, Florida, 33607, United States
Chiesi Clinical Trial Site 840356
Tampa, Florida, 33607, United States
Chiesi Clinical Trial Site 840379
Tampa, Florida, 33607, United States
Chiesi Clinical Trial Site 840131
Tampa, Florida, 33613, United States
Chiesi Clinical Trial Site 840324
Tampa, Florida, 33614, United States
Chiesi Clinical Trial Site 840309
Tampa, Florida, 33634, United States
Chiesi Clinical Trial Site 840210
The Villages, Florida, 32162, United States
Chiesi Clinical Trial Site 840129
Winter Park, Florida, 32789, United States
Chiesi Clinical Trial Site 840223
Adairsville, Georgia, 30103, United States
Chiesi Clinical Trial Site 840218
Columbus, Georgia, 31904, United States
Chiesi Clinical Trial Site 840414
Columbus, Georgia, 31904, United States
Chiesi Clinical Trial Site 840437
Cordele, Georgia, 31015, United States
Chiesi Clinical Trial Site 840390
Lawrenceville, Georgia, 30044, United States
Chiesi Clinical Trial Site 840227
Lawrenceville, Georgia, 30046, United States
Chiesi Clinical Trial Site 840138
Rincon, Georgia, 31326, United States
Chiesi Clinical Trial Site 840417
Stonecrest, Georgia, 30038, United States
Chiesi Clinical Trial Site 840383
Union City, Georgia, 30291, United States
Chiesi Clinical Trial Site 840321
Chicago, Illinois, 60602, United States
Chiesi Clinical Trial Site 840365
Chicago Ridge, Illinois, 60415, United States
Chiesi Clinical Trial Site 840407
Hammond, Indiana, 46324, United States
Chiesi Clinical Trial Site 840108
Valparaiso, Indiana, 76383, United States
Chiesi Clinical Trial Site 840318
Council Bluffs, Iowa, 51503, United States
Chiesi Clinical Trial Site 840207
Crowley, Louisiana, 70526, United States
Chiesi Clinical Trial Site 840436
Zachary, Louisiana, 70791, United States
Chiesi Clinical Trial Site 840451
Bangor, Maine, 04401, United States
Chiesi Clinical Trial Site 840447
Baltimore, Maryland, 21237, United States
Chiesi Clinical Trial Site 840376
Baltimore, Maryland, 21287, United States
Chiesi Clinical Trial Site 840199
Westminster, Maryland, 21157, United States
Chiesi Clinical Trial Site 840214
Fall River, Massachusetts, 02723, United States
Chiesi Clinical Trial Site 840322
New Bedford, Massachusetts, 02740, United States
Chiesi Clinical Trial site 840250
North Dartmouth, Massachusetts, 02747, United States
Chiesi Clinical Trial Site 840325
Dearborn, Michigan, 48124, United States
Chiesi Clinical Trial Site 840400
Dearborn, Michigan, 48126, United States
Chiesi Clinical Trial Site 840183
Farmington Hills, Michigan, 48336, United States
Chiesi Clinical Trial Site 840340
Flint, Michigan, 48504, United States
Chiesi Clinical Trial Site 840401
Flint, Michigan, 48532, United States
Chiesi Clinical Trial Site 840345
Novi, Michigan, 48375, United States
Chiesi Clinical Trial Site 840287
Southfield, Michigan, 48034, United States
Chiesi Clinical Trial Site 840415
Southfield, Michigan, 48075, United States
Chiesi Clinical Trial Site 840444
Fayette, Mississippi, 39069, United States
Chiesi Clinical Trial Site 840448
Ridgeland, Mississippi, 39157, United States
Chiesi Clinical Trial Site 840278
Chesterfield, Missouri, 63017, United States
Chiesi Clinical Trial Site 840155
Columbia, Missouri, 65203, United States
Chiesi Clinical Trial Site 840316
Richmond Heights, Missouri, 63117, United States
Chiesi Clinical Trial Site 840150
Saint Charles, Missouri, 63301, United States
Chiesi Clinical Trial Site 840282
St Louis, Missouri, 63123, United States
Chiesi Clinical Trial Site 840123
St Louis, Missouri, 63141, United States
Chiesi Clinical Trial Site 840142
St Louis, Missouri, 63141, United States
Chiesi Clinical Trial Site 840273
Missoula, Montana, 59808, United States
Chiesi Clinical Trial Site 840281
Lincoln, Nebraska, 68506, United States
Chiesi Clinical Trial Site 840329
Omaha, Nebraska, 68114, United States
Chiesi Clinical Trial Site 840213
Las Vegas, Nevada, 840213, United States
Chiesi Clinical Trial Site 840285
Las Vegas, Nevada, 89106, United States
Chiesi Clinical Trial Site 840299
Las Vegas, Nevada, 89123, United States
Chiesi Clinical Trial Site 840338
Portsmouth, New Hampshire, 03810, United States
Chiesi Clinical Trial Site 840297
Berlin, New Jersey, 08009, United States
Chiesi Clinical Trial Site 840333
Toms River, New Jersey, 08755, United States
Chiesi Clinical Trial Site 840330
Binghamton, New York, 13905, United States
Chiesi Clinical Trial Site 840397
Brooklyn, New York, 11235, United States
Chiesi Clinical Trial Site 840254
Buffalo, New York, 14201, United States
Chiesi Clinical Trial Site 840307
Buffalo, New York, 14203, United States
Chiesi Clinical Trial Site 840368
Flushing, New York, 11355, United States
Chiesi Clinical Trial Site 840362
New Windsor, New York, 12553, United States
Chiesi Clinical Trial Site 840128
The Bronx, New York, 10455, United States
Chiesi Clinical Trial Site 840215
Charlotte, North Carolina, 28207, United States
Chiesi Clinical Trial Site 840366
Charlotte, North Carolina, 28210, United States
Chiesi Clinical Trial Site 840158
Charlotte, North Carolina, 28277, United States
Chiesi Clinical Trial Site 840409
Denver, North Carolina, 28037, United States
Chiesi Clinical Trial Site 840403
Durham, North Carolina, 27705, United States
Chiesi Clinical Trial Site 840428
Gastonia, North Carolina, 28054, United States
Chiesi Clinical Trial Site 840236
Huntersville, North Carolina, 28078, United States
Chiesi Clinical Trial Site 840259
Monroe, North Carolina, 28112, United States
Chiesi Clinical Trial Site 840440
Morgantown, North Carolina, 28655, United States
Chiesi Clinical Trial Site 840194
New Bern, North Carolina, 28562, United States
Chiesi Clinical Trial Site 840120
Raleigh, North Carolina, 27607, United States
Chiesi Clinical Trial Site 840438
Raleigh, North Carolina, 27607, United States
Chiesi Clinical Trial Site 840429
Raleigh, North Carolina, 27617, United States
Chiesi Clinical Trial Site 840112
Rocky Mount, North Carolina, 27804, United States
Chiesi Clinical Trial Site 840135
Shelby, North Carolina, 28150, United States
Chiesi Clinical Trial Site 840189
Wilmington, North Carolina, 28403, United States
Chiesi Clinical Trial Site 840412
Winston-Salem, North Carolina, 27103, United States
Chiesi Clinical Trial Site 840445
Akron, Ohio, 44313, United States
Chiesi Clinical Trial Site 840104
Cincinnati, Ohio, 45231, United States
Chiesi Clinical Trial Site 840357
Cincinnati, Ohio, 45242, United States
Chiesi Clinical Trial Site 840124
Columbus, Ohio, 43215, United States
Chiesi Clinical Trial Site 840426
Dayton, Ohio, 45424, United States
Chiesi Clinical Trial Site 840302
Kettering, Ohio, 45439, United States
Chiesi Clinical Trial Site 840233
Maumee, Ohio, 43537, United States
Chiesi Clinical Trial Site 840167
Middleburg Heights, Ohio, 44130, United States
Chiesi Clinical Trial Site 840157
Toledo, Ohio, 43617, United States
Chiesi Clinical Trial Site 840203
Medford, Oregon, 97504, United States
Chiesi Clinical Trial Site 840300
Beaver, Pennsylvania, 15009, United States
Chiesi Clinical Trial Site 840308
DuBois, Pennsylvania, 15801, United States
Chiesi Clinical Trial Site 840156
Jenkintown, Pennsylvania, 19046, United States
Chiesi Clinical Trial Site 840327
Pittsburgh, Pennsylvania, 15236, United States
Chiesi Clinical Trial Site 840418
Scotland, Pennsylvania, 15683, United States
Chiesi Clinical Trial Site 840419
Smithfield, Pennsylvania, 15478, United States
Chiesi Clinical Trial Site 840450
Cranston, Rhode Island, 02920, United States
Chiesi Clinical Trial Site 840332
Cumberland, Rhode Island, 02864, United States
Chiesi Clinical Trial Site 840222
Anderson, South Carolina, 29621, United States
Chiesi Clinical Trial Site 840435
Anderson, South Carolina, 29621, United States
Chiesi Clinical Trial Site 840431
Charleston, South Carolina, 29406, United States
Chiesi Clinical Trial Site 840334
Columbia, South Carolina, 29201, United States
Chiesi Clinical Trial Site 840130
Columbia, South Carolina, 29204, United States
Chiesi Clinical Trial Site 840430
Columbia, South Carolina, 29223, United States
Chiesi Clinical Trial Site 840211
Fort Mill, South Carolina, 29707, United States
Chiesi Clinical Trial Site 840182
Gaffney, South Carolina, 29340, United States
Chiesi Clinical Trial Site 840111
Greenville, South Carolina, 29615, United States
Chiesi Clinical Trial Site 840420
Lancaster, South Carolina, 29720, United States
Chiesi Clinical Trial Site 840386
Mauldin, South Carolina, 29662, United States
Chiesi Clinical Trial Site 840100
Rock Hill, South Carolina, 29732, United States
Chiesi Clinical Trial Site 840375
Spartanburg, South Carolina, 29303, United States
Chiesi Clinical Trial Site 840106
Union, South Carolina, 29379, United States
Chiesi Clinical Trial Site 840295
West Columbia, South Carolina, 29169, United States
Chiesi Clinical Trial Site 840398
Rapid City, South Dakota, 57702, United States
Chiesi Clinical Trial Site 840305
Chattanooga, Tennessee, 37404, United States
Chiesi Clinical Trial Site 840351
Franklin, Tennessee, 37067, United States
Chiesi Clinical Trial Site 840306
Johnson City, Tennessee, 37601, United States
Chiesi Clinical Trial Site 840171
Knoxville, Tennessee, 37909, United States
Chiesi Clinical Trial Site 840361
Nashville, Tennessee, 37203, United States
Chiesi Clinical Trial Site 840271
Tullahoma, Tennessee, 37388, United States
Chiesi Clinical Trial Site 840101
Baytown, Texas, 77521, United States
Chiesi Clinical Trial Site 840114
Boerne, Texas, 78006, United States
Chiesi Clinical Trial Site 840146
Cypress, Texas, 77429, United States
Chiesi Clinical Trial Site 840413
Dallas, Texas, 75230, United States
Chiesi Clinical Trial Site 840284
Houston, Texas, 77008, United States
Chiesi Clinical Trial Site 840411
Houston, Texas, 77008, United States
Chiesi Clinical Trial Site 840389
Houston, Texas, 77030, United States
Chiesi Clinical Trial Site 840185
Houston, Texas, 77084, United States
Chiesi Clinical Trial Site 840224
Houston, Texas, 77098, United States
Chiesi Clinical Trial Site 840408
Humble, Texas, 77396, United States
Chiesi Clinical Trial Site 840102
Katy, Texas, 77494, United States
Chiesi Clinical Trial Site 840274
Katy, Texas, 77494, United States
Chiesi Clinical Trial Site 840432
Kerrville, Texas, 78028, United States
Chiesi Clinical Trial Site 840160
Lampasas, Texas, 76550, United States
Chiesi Clinical Trial Site 840424
McAllen, Texas, 78503, United States
Chiesi Clinical Trial Site 840119
McKinney, Texas, 75069, United States
Chiesi Clinical Trial Site 840442
Nederland, Texas, 77627, United States
Chiesi Clinical Trial Site 840176
North Richland Hills, Texas, 76180, United States
Chiesi Clinical Trial Site 840283
Pearland, Texas, 77584, United States
Chiesi Clinical Trial Site 840191
San Antonio, Texas, 78063, United States
Chiesi Clinical Trial Site 840320
San Antonio, Texas, 78215, United States
Chiesi Clinical Trial Site 840410
San Antonio, Texas, 78229, United States
Chiesi Clinical Trial Site 840231
Sherman, Texas, 75092, United States
Chiesi Clinical Trial Site 840396
Sherman, Texas, 75092, United States
Chiesi Clinical Trial Site 840394
Splendora, Texas, 77372, United States
Chiesi Clinical Trial Site 840221
Sugar Land, Texas, 77479, United States
Chiesi Clinical Trial Site 840139
Tomball, Texas, 77375, United States
Chiesi Clinical Trial Site 840314
Tomball, Texas, 77375, United States
Chiesi Clinical Trial Site 840337
Colchester, Vermont, 05446, United States
Chiesi Clinical Trial Site 840264
Manassas, Virginia, 20110, United States
Chiesi Clinical Trial Site 840159
Richmond, Virginia, 23219, United States
Chiesi Clinical Trial Site 840425
Richmond, Virginia, 23226, United States
Chiesi Clinical Trial Site 840423
Everett, Washington, 98208, United States
Chiesi Clinical Trial Site 840342
Renton, Washington, 98055, United States
Chiesi Clinical Trial Site 840154
Vancouver, Washington, 98664, United States
Chiesi Clinical Trial Site 840421
Kingwood, West Virginia, 26537, United States
Chiesi Clinical Trial Site 840201
Morgantown, West Virginia, 26505, United States
Chiesi Clinical Trial Site 032115
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1056ABJ, Argentina
Chiesi Clinical Trial Site 032113
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1426, Argentina
Chiesi Clinical Trial Site 032107
Ciudad Autonoma de Buenos Aire, Buenos Aires, B1837, Argentina
Chiesi Clinical Trial Site 032112
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1426ABO, Argentina
Chiesi Clinical Trial Site 032121
Ciudad Autonoma de Buenos Aire, Buenos Aires, Cl425DTG, Argentina
Chiesi Clinical Trial Site 032108
La Plata, Buenos Aires, 1900, Argentina
Chiesi Clinical Trial Site 032118
Mar del Plata, Buenos Aires, 3168, Argentina
Chiesi Clinical Trial Site 032114
Mar del Plata, Buenos Aires, B7600FZO, Argentina
Chiesi Clinical Trial Site 032102
Monte Grande, Buenos Aires, 1842, Argentina
Chiesi Clinical Trial Site 032106
Quilmes, Buenos Aires, B1878FNR, Argentina
Chiesi Clinical Trial Site 032116
San Fernando, Buenos Aires, 1646, Argentina
Chiesi Clinical Trial Site 032110
San Juan Bautista, Buenos Aires, B1853AIK, Argentina
Chiesi Clinical Trial Site 032100
Vicente López, Buenos Aires, 1602, Argentina
Chiesi Clinical Trial Site 032111
Córdoba, Córdoba Province, X5008HHW, Argentina
Chiesi Clinical Trial Site 032120
Concepción del Uruguay, Entre Ríos Province, E3260EPD, Argentina
Chiesi Clinical Trial Site 032101
Rosario, Santa Fe Province, 2000, Argentina
Chiesi Clinical Trial Site 032132
Rosario, Santa Fe Province, S2121, Argentina
Chiesi Clinical Trial Site 032117
San Miguel de Tucumán, Tucumán Province, T4000, Argentina
Chiesi Clinical Trial Site 032125
Buenos Aires, 1407, Argentina
Chiesi Clinical Trial Site 032130
Buenos Aires, C1425FVH, Argentina
Chiesi Clinical Trial Site 032133
Buenos Aires, Argentina
Chiesi Clinical Trial Site 032103
Ciudad Autonoma de Buenos Aire, 1430, Argentina
Chiesi Clinical Trial Site 032109
Ciudad Autonoma de Buenos Aire, B1602DOH, Argentina
Chiesi Clinical Trial Site 032122
Córdoba, 5000, Argentina
Chiesi Clinical Trial Site 032131
Lobos, 7240, Argentina
Chiesi Clinical Trial Site 032119
Mar del Plata, 7600, Argentina
Chiesi Clinical Trial Site 032105
Mendoza, 5500, Argentina
Chiesi Clinical Trial Site 032129
Mendoza, 5500, Argentina
Chiesi Clinical Trial Site 032126
Mendoza, M5502IDE, Argentina
Chiesi Clinical Trial Site 032123
Paraná, 3100, Argentina
Chiesi Clinical Trial Site 032128
Rosario, S2002OJN, Argentina
Chiesi Clinical Trial Site 032134
San Miguel de Tucumán, 4000, Argentina
Chiesi Clinical Trial Site 032136
San Miguel de Tucumán, 4000, Argentina
Chiesi Clinical Trial Site 032127
San Rafael, 5600, Argentina
Chiesi Clinical Trial Site 032124
Santa Fe, 3000, Argentina
Chiesi Clinical Trial Site 100125
Gabrovo, Bulgaria
Chiesi Clinical Trial Site 100109
Haskovo, Bulgaria
Chiesi Clinical Trial Site 100129
Kozloduy, 3320, Bulgaria
Chiesi Clinical Trial Site 100111
Lovech, Bulgaria
Chiesi Clinical Trial Site 100115
Montana, Bulgaria
Chiesi Clinical Trial Site 100132
Pleven, 5808, Bulgaria
Chiesi Clinical Trial Site 100101
Pleven, Bulgaria
Chiesi Clinical Trial Site 100131
Plovdiv, 4003, Bulgaria
Chiesi Clinical Trial Site 100102
Plovdiv, Bulgaria
Chiesi Clinical Trial Site 100126
Plovdiv, Bulgaria
Chiesi Clinical Trial Site 100128
Razgrad, 7200, Bulgaria
Chiesi Clinical Trial Site 100104
Rousse, Bulgaria
Chiesi Clinical Trial Site 100113
Rousse, Bulgaria
Chiesi Clinical Trial Site 100100
Sofia, Bulgaria
Chiesi Clinical Trial Site 100110
Sofia, Bulgaria
Chiesi Clinical Trial Site 100112
Sofia, Bulgaria
Chiesi Clinical Trial Site 100116
Sofia, Bulgaria
Chiesi Clinical Trial Site 100117
Sofia, Bulgaria
Chiesi Clinical Trial Site 100118
Sofia, Bulgaria
Chiesi Clinical Trial Site 100119
Sofia, Bulgaria
Chiesi Clinical Trial Site 100121
Sofia, Bulgaria
Chiesi Clinical Trial Site 100123
Sofia, Bulgaria
Chiesi Clinical Trial Site 100124
Sofia, Bulgaria
Chiesi Clinical Trial Site 100127
Sofia, Bulgaria
Chiesi Clinical Trial Site 100103
Stara Zagora, Bulgaria
Chiesi Clinical Trial Site 100107
Stara Zagora, Bulgaria
Chiesi Clinical Trial Site 100130
Varna, 9020, Bulgaria
Chiesi Clinical Trial Site 100122
Veliko Tarnovo, Bulgaria
Chiesi Clinical Trial Site 100106
Vidin, Bulgaria
Chiesi Clinical Trial Site 100114
Vidin, Bulgaria
Chiesi Clinical Trial Site 124103
Edmonton, Alberta, T5A 4L8, Canada
Chiesi Clinical Trial Site 124105
Sherwood Park, Alberta, T8H 0N2, Canada
Chiesi Clinical Trial Site 124102
Burlington, Ontario, L7N 3V2, Canada
Chiesi Clinical Trial Site 124104
Greater Sudbury, Ontario, P3C 1X3, Canada
Chiesi Clinical Trial Site 124100
Windsor, Ontario, N8X 1T3, Canada
Chiesi Clinical Trial Site 124106
Trois-Rivières, Quebec, G8T 7A1, Canada
Chiesi Clinical Trial Site 203101
Brandýs nad Labem, Czechia
Chiesi Clinical Trial Site 203107
Jindřichův Hradec, Czechia
Chiesi Clinical Trial Site 203109
Miroslav, Czechia
Chiesi Clinical Trial Site 203116
Prague, 11000, Czechia
Chiesi Clinical Trial Site 203115
Prague, 140 00, Czechia
Chiesi Clinical Trial Site 203114
Prague, Czechia
Chiesi Clinical Trial Site 203112
Rokycany, Czechia
Chiesi Clinical Trial Site 203108
Strakonice, Czechia
Chiesi Clinical Trial Site 203105
Tábor, Czechia
Chiesi Clinical Trial Site 203104
Teplice, Czechia
Chiesi Clinical Trial Site 203110
Varnsdorf, Czechia
Chiesi Clinical Trial Site 348121
Komló, BA, 7300, Hungary
Chiesi Clinical Trial Site 348122
Pécs, BA, 7626, Hungary
Chiesi Clinical Trial Site 348124
Csorna, GS, 9300, Hungary
Chiesi Clinical Trial Site 348126
Szolnok, JN, 5000, Hungary
Chiesi Clinical Trial Site 348107
Balassagyarmat, Nógrád megye, Hungary
Chiesi Clinical Trial Site 348120
Gödöllő, Pest County, Hungary
Chiesi Clinical Trial Site 348104
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Chiesi Clinical Trial Site 348109
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Chiesi Clinical Trial Site 348105
Szombathely, Vas County, Hungary
Chiesi Clinical Trial Site 348118
Debrecen, Hungary
Chiesi Clinical Trial Site 348112
Hajdúnánás, Hungary
Chiesi Clinical Trial Site 348116
Hatvan, Hungary
Chiesi Clinical Trial Site 348103
Monor, Hungary
Chiesi Clinical Trial Site 348125
Sellye, 7960, Hungary
Chiesi Clinical Trial Site 484110
Tijuana, Estado de Baja California, Mexico
Chiesi Clinical Trial Site 484113
Guadalajara, Jalisco, 44610, Mexico
Chiesi Clinical Trial Site 484100
Guadalajara, Jalisco, Mexico
Chiesi Clinical Trial Site 484102
Guadalajara, Jalisco, Mexico
Chiesi Clinical Trial Site 484104
Guadalajara, Jalisco, Mexico
Chiesi Clinical Trial Site 484106
Guadalajara, Jalisco, Mexico
Chiesi Clinical Trial Site 484112
Guadalajara, Jalisco, Mexico
Chiesi Clinical Trial Site 484115
Guadalupe, Jalisco, 44200, Mexico
Chiesi Clinical Trial Site 484103
Cuauhtémoc, Mexico City, Mexico
Chiesi Clinical Trial Site 484107
Morelia, Michoacán, Mexico
Chiesi Clinical Trial Site 484101
Monterrey, Nuevo León, Mexico
Chiesi Clinical Trial Site 484111
Monterrey, Nuevo León, Mexico
Chiesi Clinical Trial Site 484116
Chihuahua City, 31217, Mexico
Chiesi Clinical Trial Site 484105
Chihuahua City, Mexico
Chiesi Clinical Trial Site 484109
Chihuahua City, Mexico
Chiesi Clinical Trial Site 484108
Tlalpan, Mexico
Chiesi Clinical Trial Site 616125
Bialystok, 15-003, Poland
Chiesi Clinical Trial Site 616119
Bialystok, Poland
Chiesi Clinical Trial Site 616100
Giżycko, Poland
Chiesi Clinical Trial Site 616113
Grudziądz, Poland
Chiesi Clinical Trial Site 616116
Katowice, Poland
Chiesi Clinical Trial Site 616122
Krakow, 30-149, Poland
Chiesi Clinical Trial Site 616106
Krakow, Poland
Chiesi Clinical Trial Site 616109
Krakow, Poland
Chiesi Clinical Trial Site 616118
Krakow, Poland
Chiesi Clinical Trial Site 616103
Lodz, Poland
Chiesi Clinical Trial Site 616128
Olsztyn, Poland
Chiesi Clinical Trial Site 616117
Ostrowiec, Poland
Chiesi Clinical Trial Site 616105
Ostróda, Poland
Chiesi Clinical Trial Site 616123
Poznan, 60-214, Poland
Chiesi Clinical Trial Site 616107
Poznan, Poland
Chiesi Clinical Trial Site 616110
Poznan, Poland
Chiesi Clinical Trial Site 616108
Rzeszów, Poland
Chiesi Clinical Trial Site 616114
Skierniewice, Poland
Chiesi Clinical Trial Site 616120
Skorzewo, 60-185, Poland
Chiesi Clinical Trial Site 616102
Sosnowiec, Poland
Chiesi Clinical Trial Site 616111
Tarnów, Poland
Chiesi Clinical Trial Site 616115
Torun, Poland
Chiesi Clinical Trial Site 616127
Warsaw, 00-215, Poland
Chiesi Clinical Trial Site 616126
Wroclaw, 54-239, Poland
Chiesi Clinical Trial Site 616104
Wroclaw, Poland
Chiesi Clinical Trial Site 616112
Wroclaw, Poland
Chiesi Clinical Trial Site 616101
Zawadzkie, Poland
Chiesi Clinical Trial Site 840393
Guaynabo, 00968, Puerto Rico
Chiesi Clinical Trial Site 642102
Oradea, Bihor County, 410169, Romania
Chiesi Clinical Trial Site 642104
Cluj-Napoca, Cluj, 400371, Romania
Chiesi Clinical Trial Site 642120
Deva, Hunedoara County, 330162, Romania
Chiesi Clinical Trial Site 642107
Bragadiru, Ilfov, 077025, Romania
Chiesi Clinical Trial Site 642119
Timișoara, Timiș County, 300336, Romania
Chiesi Clinical Trial Site 642109
Bacau, 600252, Romania
Chiesi Clinical Trial Site 642106
Bragadiru, 077025, Romania
Chiesi Clinical Trial Site 642117
Brasov, 500283, Romania
Chiesi Clinical Trial Site 642108
Bucharest, 012071, Romania
Chiesi Clinical Trial Site 642103
Bucharest, 020125, Romania
Chiesi Clinical Trial Site 642113
Bucharest, 11025, Romania
Chiesi Clinical Trial Site 642115
Caracal, 235200, Romania
Chiesi Clinical Trial Site 642111
Cluj-Napoca, 400275, Romania
Chiesi Clinical Trial Site 642105
Constanța, 900433, Romania
Chiesi Clinical Trial Site 642110
Craiova, 200515, Romania
Chiesi Clinical Trial Site 642118
Craiova, 200515, Romania
Chiesi Clinical Trial Site 642101
Iași, 700141, Romania
Chiesi Clinical Trial Site 642114
Reșca, 237143, Romania
Chiesi Clinical Trial Site 642112
Satu Mare, 44055, Romania
Chiesi Clinical Trial Site 642116
Timișoara, 300134, Romania
Related Publications (33)
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.
PMID: 22743675BACKGROUNDLopez 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.
PMID: 16452599BACKGROUNDLozano 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.
PMID: 23245604BACKGROUNDMathers 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.
PMID: 17132052BACKGROUNDMontes 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.
PMID: 19818867BACKGROUNDBestall 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.
PMID: 10377201BACKGROUNDJones 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.
PMID: 19720809BACKGROUNDLane 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.
PMID: 30362922BACKGROUNDLipson DA, Barnhart F, Brealey N, Brooks J, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Martinez FJ, Singh D, Tabberer M, Wise RA, Pascoe SJ; IMPACT Investigators. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. N Engl J Med. 2018 May 3;378(18):1671-1680. doi: 10.1056/NEJMoa1713901. Epub 2018 Apr 18.
PMID: 29668352BACKGROUNDWelte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, Kessler R. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Oct 15;180(8):741-50. doi: 10.1164/rccm.200904-0492OC. Epub 2009 Jul 30.
PMID: 19644045BACKGROUNDHanania NA, Crater GD, Morris AN, Emmett AH, O'Dell DM, Niewoehner DE. Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD. Respir Med. 2012 Jan;106(1):91-101. doi: 10.1016/j.rmed.2011.09.002. Epub 2011 Oct 29.
PMID: 22040533BACKGROUNDJung KS, Park HY, Park SY, Kim SK, Kim YK, Shim JJ, Moon HS, Lee KH, Yoo JH, Lee SD; Korean Academy of Tuberculosis and Respiratory Diseases study group; Korea Chronic Obstructive Pulmonary Disease study group. Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: a randomized controlled study. Respir Med. 2012 Mar;106(3):382-9. doi: 10.1016/j.rmed.2011.09.004. Epub 2011 Oct 4.
PMID: 21975275BACKGROUNDLipson DA, Barnacle H, Birk R, Brealey N, Locantore N, Lomas DA, Ludwig-Sengpiel A, Mohindra R, Tabberer M, Zhu CQ, Pascoe SJ. FULFIL Trial: Once-Daily Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Aug 15;196(4):438-446. doi: 10.1164/rccm.201703-0449OC.
PMID: 28375647BACKGROUNDFerguson GT, Rabe KF, Martinez FJ, Fabbri LM, Wang C, Ichinose M, Bourne E, Ballal S, Darken P, DeAngelis K, Aurivillius M, Dorinsky P, Reisner C. Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, phase 3 randomised controlled trial. Lancet Respir Med. 2018 Oct;6(10):747-758. doi: 10.1016/S2213-2600(18)30327-8. Epub 2018 Sep 16.
PMID: 30232048BACKGROUNDSingh D, Papi A, Corradi M, Pavlisova I, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Vestbo J. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting beta2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Lancet. 2016 Sep 3;388(10048):963-73. doi: 10.1016/S0140-6736(16)31354-X. Epub 2016 Sep 1.
PMID: 27598678BACKGROUNDVestbo J, Papi A, Corradi M, Blazhko V, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Singh D. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. Lancet. 2017 May 13;389(10082):1919-1929. doi: 10.1016/S0140-6736(17)30188-5. Epub 2017 Apr 3.
PMID: 28385353BACKGROUNDPapi A, Vestbo J, Fabbri L, Corradi M, Prunier H, Cohuet G, Guasconi A, Montagna I, Vezzoli S, Petruzzelli S, Scuri M, Roche N, Singh D. Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial. Lancet. 2018 Mar 17;391(10125):1076-1084. doi: 10.1016/S0140-6736(18)30206-X. Epub 2018 Feb 9.
PMID: 29429593BACKGROUNDWedzicha JA, Singh D, Vestbo J, Paggiaro PL, Jones PW, Bonnet-Gonod F, Cohuet G, Corradi M, Vezzoli S, Petruzzelli S, Agusti A; FORWARD Investigators. Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations. Respir Med. 2014 Aug;108(8):1153-62. doi: 10.1016/j.rmed.2014.05.013. Epub 2014 Jun 6.
PMID: 24953015BACKGROUNDJones PW, Tabberer M, Chen WH. Creating scenarios of the impact of COPD and their relationship to COPD Assessment Test (CAT) scores. BMC Pulm Med. 2011 Aug 11;11:42. doi: 10.1186/1471-2466-11-42.
PMID: 21835018BACKGROUNDMullerova H, Dransfield MT, Thomashow B, Jones PW, Rennard S, Karlsson N, Fageras M, Metzdorf N, Petruzzelli S, Rommes J, Sciurba FC, Tabberer M, Merrill D, Tal-Singer R. Clinical Development and Research Applications of the Chronic Obstructive Pulmonary Disease Assessment Test. Am J Respir Crit Care Med. 2020 May 1;201(9):1058-1067. doi: 10.1164/rccm.201907-1369PP. No abstract available.
PMID: 31815521BACKGROUNDKon SS, Canavan JL, Jones SE, Nolan CM, Clark AL, Dickson MJ, Haselden BM, Polkey MI, Man WD. Minimum clinically important difference for the COPD Assessment Test: a prospective analysis. Lancet Respir Med. 2014 Mar;2(3):195-203. doi: 10.1016/S2213-2600(14)70001-3. Epub 2014 Feb 4.
PMID: 24621681BACKGROUNDMiller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PMID: 16055882BACKGROUNDMiller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten C, Gustafsson P, Jensen R, Macintyre N, McKay RT, Pedersen OF, Pellegrino R, Viegi G, Wanger J. Standardisation of lung function testing: the authors' replies to readers' comments. Eur Respir J. 2010 Dec;36(6):1496-8. doi: 10.1183/09031936.00130010. No abstract available.
PMID: 21119213BACKGROUNDAnthonisen NR, Manfreda J, Warren CP, Hershfield ES, Harding GK, Nelson NA. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 1987 Feb;106(2):196-204. doi: 10.7326/0003-4819-106-2-196.
PMID: 3492164BACKGROUNDSeemungal TA, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998 May;157(5 Pt 1):1418-22. doi: 10.1164/ajrccm.157.5.9709032.
PMID: 9603117BACKGROUNDJones PW. St. George's Respiratory Questionnaire: MCID. COPD. 2005 Mar;2(1):75-9. doi: 10.1081/copd-200050513.
PMID: 17136966BACKGROUNDJones P, Lareau S, Mahler DA. Measuring the effects of COPD on the patient. Respir Med. 2005 Dec;99 Suppl B:S11-8. doi: 10.1016/j.rmed.2005.09.011. Epub 2005 Oct 19.
PMID: 16236492BACKGROUNDJones PW, Gelhorn H, Wilson H, Karlsson N, Menjoge S, Mullerova H, Rennard SI, Tal-Singer R, Merrill D, Tabberer M. Responder Analyses for Treatment Effects in COPD Using the St George's Respiratory Questionnaire. Chronic Obstr Pulm Dis. 2017 Mar 2;4(2):124-131. doi: 10.15326/jcopdf.4.2.2017.0130.
PMID: 28848921BACKGROUNDRoland NJ, Bhalla RK, Earis J. The local side effects of inhaled corticosteroids: current understanding and review of the literature. Chest. 2004 Jul;126(1):213-9. doi: 10.1378/chest.126.1.213.
PMID: 15249465BACKGROUNDEllepola AN, Samaranayake LP. Inhalational and topical steroids, and oral candidosis: a mini review. Oral Dis. 2001 Jul;7(4):211-6.
PMID: 11575870BACKGROUNDRoger JH, Bratton DJ, Mayer B, Abellan JJ, Keene ON. Treatment policy estimands for recurrent event data using data collected after cessation of randomised treatment. Pharm Stat. 2019 Jan;18(1):85-95. doi: 10.1002/pst.1910. Epub 2018 Nov 8.
PMID: 30406948BACKGROUNDFerenci P, Lockwood A, Mullen K, Tarter R, Weissenborn K, Blei AT. Hepatic encephalopathy--definition, nomenclature, diagnosis, and quantification: final report of the working party at the 11th World Congresses of Gastroenterology, Vienna, 1998. Hepatology. 2002 Mar;35(3):716-21. doi: 10.1053/jhep.2002.31250.
PMID: 11870389BACKGROUNDBajaj JS, Cordoba J, Mullen KD, Amodio P, Shawcross DL, Butterworth RF, Morgan MY; International Society for Hepatic Encephalopathy and Nitrogen Metabolism (ISHEN). Review article: the design of clinical trials in hepatic encephalopathy--an International Society for Hepatic Encephalopathy and Nitrogen Metabolism (ISHEN) consensus statement. Aliment Pharmacol Ther. 2011 Apr;33(7):739-47. doi: 10.1111/j.1365-2036.2011.04590.x. Epub 2011 Feb 9.
PMID: 21306407BACKGROUND
Related Links
- Global Initiative for Chronic Obstructive Lung Disease: Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (2020 Report)
- ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
- COPD Assessment Test (CAT)
- Measuring shortness of breath (dyspnea) in COPD.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Siler, MD
Midwest Chest Consultants
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2020
First Posted
March 25, 2020
Study Start
April 28, 2022
Primary Completion
January 12, 2026
Study Completion
January 12, 2026
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share