COPDPhase 3NCT02465567

Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)

A Phase 3 study testing BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg and BGF MDI 160/14.4/9.6 μg in people with COPD, run by Pearl Therapeutics, Inc. at 741 sites in 26 countries.

Completed

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

Official record

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Trial summary

This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: COPD
What is being tested?: BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg and BGF MDI 160/14.4/9.6 μg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8,588 participants
Where: 741 sitesin 26 countries
Study dates: 30 Jun 2015to 26 Jul 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

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

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS),
Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <65% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).
Subjects with history of exacerbations.
Please refer to the study protocol for the complete inclusion criteria list.

Who cannot join

Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening)
Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening)
Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia.

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Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated.
Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs.
Please refer to the study protocol for the complete inclusion criteria list.

Trial locations and contacts

741 sites in 26 countries.

Country

City, postcode or hospital

723 sites in 26 countries

United States300 sites

Research Site
Abingdon, Virginia, 24210
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Altoona, Pennsylvania, 16602
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Andalusia, Alabama, 36420
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Anderson, South Carolina, 29621
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Arlington, Texas, 76012
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Arlington, Texas, 76014
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Asheville, North Carolina, 28801
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Athens, Alabama, 35611
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Atlanta, Georgia, 30308
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Atlanta, Georgia, 30328
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Atlanta, Georgia, 30331
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Atlanta, Georgia, 30345
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Bakersfield, California, 93301
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Baltimore, Maryland, 21224
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Baltimore, Maryland, 21236
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Baltimore, Maryland, 21237
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Bangor, Maine, 04401
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Belleville, Illinois, 62220
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Bellevue, Nebraska, 68005
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Bellevue, Nebraska, 68123
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Bellevue, Washington, 98007
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Belton, Missouri, 64012
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Beverly Hills, California, 90212
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Billings, Montana, 59102
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Biloxi, Mississippi, 39531
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Birmingham, Alabama, 35209
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Birmingham, Alabama, 35235
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Birmingham, Alabama, 35243
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Blue Ash, Ohio, 45242
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Blue Ridge, Georgia, 30513
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Boerne, Texas, 78006
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Boynton Beach, Florida, 33435
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Brandon, Florida, 33511
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Bronxville, New York, 10708
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Brooklyn, New York, 11229
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Buckley, Michigan, 49620
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Burke, Virginia, 22015
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Burlington, North Carolina, 27215
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Cadillac, Michigan, 49601
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Canton, Michigan, 48187
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Caro, Michigan, 48723
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Carrollton, Texas, 75007
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Cerritos, California, 90703
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Champaign, Illinois, 61820
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Charleston, South Carolina, 29406
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Charleston, South Carolina, 29412
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Charlotte, North Carolina, 28207
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Charlotte, North Carolina, 28210
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Charlotte, North Carolina, 28277
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Chattanooga, Tennessee, 37404
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Chesterfield, Missouri, 63017
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Chicago, Illinois, 60607
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Cincinnati, Ohio, 45231
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Cincinnati, Ohio, 45245
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Clearwater, Florida, 33756
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Clearwater, Florida, 33765
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Clermont, Florida, 34711
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Colorado Springs, Colorado, 80910
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Colorado Springs, Colorado, 80922
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Columbia, Maryland, 21044
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Columbia, South Carolina, 29201
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Columbus, Georgia, 31904
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Columbus, Ohio, 43123
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Conway, Arkansas, 72032
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Coral Gables, Florida, 33134
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Corsicana, Texas, 75110
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Council Bluffs, Iowa, 51503
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Crowley, Louisiana, 70526
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Cypress, Texas, 77429
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Dacula, Georgia, 30019
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Dayton, Ohio, 45419
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Dayton, Ohio, 45459
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Daytona Beach, Florida, 32117
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Dothan, Alabama, 36303
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Dublin, Ohio, 43016
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Duluth, Georgia, 30096
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Duncanville, Texas, 75116
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Easley, South Carolina, 29640
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East Providence, Rhode Island, 02914
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Edina, Minnesota, 55435
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Edmond, Oklahoma, 73034
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El Cajon, California, 92020
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El Paso, Texas, 79903
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Elizabeth City, North Carolina, 27909
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Erie, Pennsylvania, 16508
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Escondido, California, 92025
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Fargo, North Dakota, 58104
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Farmington Hills, Michigan, 48336
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Flint, Michigan, 48504
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Florence, Alabama, 35630
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Foley, Alabama, 36535
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Fort Collins, Colorado, 80525
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Fort Lauderdale, Florida, 33308
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Fort Mitchell, Kentucky, 41017
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Fort Worth, Texas, 76104
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Fort Worth, Texas, 76109
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Fresno, California, 93702
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Fridley, Minnesota, 55432
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Gaffney, South Carolina, 29340
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Gaffney, South Carolina, 29341
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Gainesville, Florida, 32607
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Gastonia, North Carolina, 28054
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Gold River, California, 95670
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Greenfield, Wisconsin, 53228
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Greensboro, North Carolina, 27408
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Greenville, South Carolina, 29615
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Greer, South Carolina, 29650
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Greer, South Carolina, 29651
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Gulf Shores, Alabama, 36542
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Hawaiian Gardens, California, 90716
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Hendersonville, North Carolina, 28739
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Hendersonville, Tennessee, 37075
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Hialeah, Florida, 33012
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Hialeah, Florida, 33029
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Hickory, North Carolina, 28601
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Hodges, South Carolina, 29653
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Hollywood, Florida, 33024
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Homestead, Florida, 33030
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Houston, Texas, 77008
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Houston, Texas, 77043
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Houston, Texas, 77058
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Houston, Texas, 77070
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Houston, Texas, 77074
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Houston, Texas, 77079
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Houston, Texas, 77084
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Houston, Texas, 77089
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Houston, Texas, 77099
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Huntersville, North Carolina, 28078
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Huntington Beach, California, 92647
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Huntington Park, California, 90255-6046
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Huntsville, Texas, 77340
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Jamaica, New York, 11435
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Jasper, Alabama, 35501
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Johnson City, Tennessee, 37601
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Katy, Texas, 77450
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Kerrville, Texas, 78028
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Kettering, Ohio, 45429
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Killeen, Texas, 76543
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Kingwood, Texas, 77339
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Kissimmee, Florida, 34741
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Kissimmee, Florida, 34744
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Knoxville, Tennessee, 37912
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La Mirada, California, 90638
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Lafayette, Colorado, 80026
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Lafayette, Louisiana, 70508
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Lake Charles, Louisiana, 70601
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Lakewood, California, 90712
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Lampasas, Texas, 76550
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Lancaster, South Carolina, 29720
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Las Vegas, Nevada, 89106
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Lawrenceville, Georgia, 30046
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Leesburg, Florida, 34748
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Lenoir, North Carolina, 28645
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Lewisville, Texas, 75067
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Little Rock, Arkansas, 72205
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Little Rock, Arkansas, 72209
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Longview, Texas, 75605
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Los Angeles, California, 90017
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Los Angeles, California, 90025
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Los Angeles, California, 90036
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Los Angeles, California, 90048
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Loxahatchee Groves, Florida, 33470
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Lufkin, Texas, 75904
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Marlborough, Massachusetts, 01752
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Marlton, New Jersey, 08053
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Maumee, Ohio, 43537
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McKinney, Texas, 75069
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McKinney, Texas, 75071
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Medford, Oregon, 97504
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Methuen, Massachusetts, 01844
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Miami, Florida, 33012
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Miami, Florida, 33125
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Miami, Florida, 33126
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Miami, Florida, 33144
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Miami, Florida, 33155
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Miami, Florida, 33165
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Miami, Florida, 33174
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Miami, Florida, 33175
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Miami, Florida, 33186
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Miami Lakes, Florida, 33014
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Michigan City, Indiana, 46360
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Midvale, Utah, 84047
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Minneapolis, Minnesota, 55407
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Mobile, Alabama, 36608
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Monroe, North Carolina, 28112
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Monroeville, Pennsylvania, 15665
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Montgomery, Alabama, 36106
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Mooresville, North Carolina, 28117
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Morganton, North Carolina, 28655
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Morgantown, West Virginia, 26505
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Mount Airy, North Carolina, 27030
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Mt. Pleasant, South Carolina, 29464
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New Bern, North Carolina, 28562
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New Orleans, Louisiana, 70115
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New Windsor, New York, 12553
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New York, New York, 10016
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Newport Beach, California, 92663
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Newport News, Virginia, 23606
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Norcross, Georgia, 30071
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North Dartmouth, Massachusetts, 02747
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North Little Rock, Arkansas, 72117
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Northridge, California, 91324
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O'Fallon, Illinois, 62269
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Oklahoma City, Oklahoma, 73103
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Old Point Station, South Carolina, 29707
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Opelousas, Louisiana, 70570
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Ormond Beach, Florida, 32174
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Owensboro, Kentucky, 42303
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Paducah, Kentucky, 42003
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Palm Springs, California, 92262
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Panama City, Florida, 32405
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Pearland, Texas, 77584
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Pembroke Pines, Florida, 33029
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Pensacola, Florida, 32503
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Peoria, Arizona, 85381
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Pflugerville, Texas, 78660
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Philadelphia, Pennsylvania, 19114
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Phoenix, Arizona, 85012
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Phoenix, Arizona, 85018
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Phoenix, Arizona, 85020
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Phoenixville, Pennsylvania, 19460
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Pittsburgh, Pennsylvania, 15236
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Pittsburgh, Pennsylvania, 15241
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Pittsburgh, Pennsylvania, 15243
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Plano, Texas, 75093
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Port Charlotte, Florida, 33952
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Port Huron, Michigan, 48060
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Portland, Oregon, 97202
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Portsmouth, New Hampshire, 03801
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Poway, California, 92064
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Providence, Rhode Island, 02908
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Quartz Hill, California, 93536
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Raleigh, North Carolina, 27612
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Rancho Mirage, California, 92270
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Rapid City, South Dakota, 57702
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Reno, Nevada, 89519
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Richland, Washington, 99352
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Richmond, Virginia, 23114
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Richmond, Virginia, 23219
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Richmond, Virginia, 23220
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Richmond, Virginia, 23225
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Richmond, Virginia, 23230
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Richmond, Virginia, 23235
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Rincon, Georgia, 31326
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Riverdale, Georgia, 30274
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Riverside, California, 92506
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Rochester, Michigan, 48307
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Rock Hill, South Carolina, 29732
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Rolling Hills Estates, California, 90274
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Sacramento, California, 95821
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Sacramento, California, 95823
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Sacramento, California, 95831
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Saint Charles, Missouri, 63301
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Salt Lake City, Utah, 84102
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San Antonio, Texas, 78229
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San Antonio, Texas, 78258
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San Diego, California, 92117
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San Diego, California, 92120
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Santa Ana, California, 92704
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Santa Ana, California, 92705
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Santa Monica, California, 90404
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Sarasota, Florida, 34239
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Savannah, Georgia, 31406
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Scottdale, Pennsylvania, 15683
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Scottsboro, Alabama, 35768
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Scottsdale, Arizona, 85258
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Sealy, Texas, 77474
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Seneca, South Carolina, 29678
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Sheffield, Alabama, 35660
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Shelby, North Carolina, 28150
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Sherman, Texas, 75092
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Skokie, Illinois, 60076
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Southfield, Michigan, 48034
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Spartanburg, South Carolina, 29301
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Spartanburg, South Carolina, 29303
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Splendora, Texas, 77372
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Spokane, Washington, 99202
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Spokane, Washington, 99216
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St Louis, Missouri, 63141
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St Louis, Missouri, 63143
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St. Petersburg, Florida, 33704
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St. Petersburg, Florida, 33707
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St. Petersburg, Florida, 33710
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Stockton, California, 95207
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Sunset, Louisiana, 70584
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Tacoma, Washington, 98405
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Tampa, Florida, 33603
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Tampa, Florida, 33607
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The Bronx, New York, 10455
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The Bronx, New York, 10457
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The Bronx, New York, 10459
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The Bronx, New York, 10461
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The Bronx, New York, 10468
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The Woodlands, Texas, 77380
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Toledo, Ohio, 43617
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Toms River, New Jersey, 08755
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Torrance, California, 90503
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Troy, Michigan, 48085
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Tulsa, Oklahoma, 74136
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Tustin, California, 92780

Other trials in United States

Germany71 sites

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Aschaffenburg, 63739
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Augsburg, 86150
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Bad Wörishofen, 86825
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Bamberg, 96049
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Bergisch Gladbach, 51429
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Berlin, 10117
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Berlin, 10119
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Berlin, 10367
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Berlin, 10717
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Berlin, 10787
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Berlin, 10969
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Berlin, 12157
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Berlin, 12159
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Berlin, 12203
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Berlin, 13187
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Berlin, 14059
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Bonn, 53119
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Bonn, 53123
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Cologne, 51069
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Cottbus, 03044
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Darmstadt, 64283
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Deggendorf, 94469
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Deggingen, 73326
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Dortmund, 44263
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Düren, 52349
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Erlangen, 91052
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Essen, 45355
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Essen, 45359
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Frankfurt, 60596
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Frankfurt am Main, 60389
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Frankfurt am Main, 60596
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Gelsenkirchen, 45879
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Grosshansdof, 22927
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Halle, 06108
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Hamburg, 20354
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Hamburg, 22299
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Hanover, 30167
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Hanover, 30625
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Hanover, D-30173
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Ibbenbueren, 49477
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Kiel, 24105
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Koblenz, 56068
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Landsberg, 86899
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Leipzig, 04103
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Leipzig, 04107
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Leipzig, 04157
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Leipzig, 04207
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Leipzig, 04275
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Leipzig, 04357
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Lübeck, 23552
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Magdeburg, 39120
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Mainz, 55131
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Marburg, 35037
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München, 80339
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München, 80539
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Münster, 48145
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Neu-Isenburg, 63263
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Peine, 31224
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Potsdam, 14469
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Radebeul, 01445
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Rosenheim, 83022
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Rüdersdorf, 15562
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Rüsselsheim am Main, D-65428
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Schleswig, 24837
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Schwedt, 16303
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Wardenburg, 26203
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Weinheim, 69469
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Wiesbaden, 65189
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Wiesloch, 69168
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Witten, 58452
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Zerbst, 39261

Other trials in Germany

China39 sites

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Baotou, 14010
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Beijing, 100020
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Beijing, 100034
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Beijing, 100050
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Beijing, CN-100029
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Changsha, 410004
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Changsha, 410005
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Changsha, 410078
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Chengdu, 610041
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Guangzhou, 510080
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Guangzhou, 510150
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Guangzhou, 510220
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Guiyang, 550004
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Haikou, 570208
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Hangzhou, 310003
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Hangzhou, 310006
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Hohhot, 010017
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Hohhot, 010050
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Hohhot, 610078
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Lanzhou, 730000
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Linhai, 317000
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Nanchang, 330006
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Nanjing, 210000
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Nanjing, 210006
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Nanjing, CN-210000
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Pingxiang, 337055
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Shanghai, 200135
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Shanghai, 201199
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Shenyang, 110001
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Shenzhen, 518020
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Shenzhen, 518029
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Shijiazhuang, 050051
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Shijiazhuang, 50051
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Wuhan, 430033
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Xi'an, 710004
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Xiangtan, 411100
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Xuzhou, 221006
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Yanji, 133000
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Zhanjiang, 524001

Other trials in China

Argentina35 sites

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Buenos Aires, 1015
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Buenos Aires, C1121ABE
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Buenos Aires, C1414AIF
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Buenos Aires, C1425BEN
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CABA, C1056ABJ
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Capital Federal, C1122AAK
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Ciudad Autónoma de Bs. As., 1426
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Ciudad Autonoma de Buenos Aire, C1028AAP
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Ciudad Autonoma de Buenos Aire, C1120AAC
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Ciudad Autonomade Buenos Aires, 1426
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Ciudad Capital, 5500
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Ciudad de Buenos Aire, C1425BEN
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Córdoba, X5003DCE
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Córdoba, X5008HHW
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Florida, B1602DQD
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La Plata, 1900
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Lanus, B1824KAJ
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Mar del Plata, 7600
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Mar del Plata, B7600FZN
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Mendoza, 5500
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Mendoza, M5500GIP
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Mendoza, M5500GPD
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Monte Grande, 1842
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Paraná, E3100XAI
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Quilmes, B1878FNR
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Rosario, 2000
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Rosario, 2002
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Rosario, S2000DEJ
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San Fernando, 1646
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San Juan Bautista, 1888
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San Miguel de Tucumán, 4000
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San Miguel de Tucumán, T4000IAR
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Santa Fe, S3000ASF
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Santa Fe, S3000FWO
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Santa Rosa, L6300EAN

Other trials in Argentina

Spain29 sites

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A Coruña, 15011A
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Alcobendas, 28100
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Alicante, 03004
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Alzira, 46410
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Badalona(Barcelona), 08916
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Barcelona, 08003
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Barcelona, 08006
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Barcelona, 08023
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Barcelona, 08028
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Barcelona, 08041
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Barcelona, 08550
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Cartagena, 30202
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Girona, 17005
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Laredo, 39770
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Lleida, 25198
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Madrid, 28007
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Madrid, 28040
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Málaga, 29010
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Marbella (Málaga), 29603
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Mataró, 08303
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Mérida (Badajoz), 06800
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Pamplona, 31008
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Peralada, 17491
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Ponferrada, 24411
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Sabadell, 08208
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Salamanca, 37007
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Sant Boi de Llobregat, 08830
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Valencia, 46015
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Zaragoza, 50009

Other trials in Spain

Canada24 sites

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Ajax, Ontario, L1S 2J5
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Burlington, Ontario, L7N 3V2
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Edmonton, Alberta, T5A 4L8
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Gatineau, Quebec, J8Y 6S8
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Greater Sudbury, Ontario, P3A 1W8
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Hamilton, Ontario, L8N 4A6
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Lévis, Quebec, G6W 0M5
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Mirabel, Quebec, J7J 2K8
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Mississauga, Ontario, L4V 1P1
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Montreal, Quebec, H1M 1B1
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Montreal, Quebec, H2X 1P1
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Pointe-Claire, Quebec, H9R 3J1
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Québec, Quebec, G1G 3Y8
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Québec, Quebec, G1V 4G5
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Saint-Charles-Borromée, Quebec, J6E 2B4
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Saint-Jérôme, Quebec, J7Z 5T3
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Sarnia, Ontario, N7T4X3
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Saskatoon, Saskatchewan, S7N 0W8
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Sherwood Park, Alberta, T8L 0N2
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Truro, Nova Scotia, B2N 1L2
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Vancouver, British Columbia, V5X04
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Vancouver, CA, V5Z 4E1
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Windsor, Ontario, N8X 1T3
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Winnipeg, Manitoba, R2K 3S8

Other trials in Canada

United Kingdom21 sites

Research Site
Belfast, BT7 2EB
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Birmingham, B15 2WB
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Birmingham, B9 5SS
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Blackpool, FY3 7EN
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Blackpool, FY4 3AD
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Bradford, BND9 6RJ
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Chesterfield, S40 4AA
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Corby, NN17 2UR
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Edinburgh, EH16 4SA
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Glasgow, G69 7AD
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Kenilworth, CV8 1JD
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Liverpool, L14 3PE
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London, EC1M 6BQ
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London, NW3 2PF
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Middlesex, HA2 2RN
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Norwich, NR4 7TJ
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Peterborough, PE8 6PL
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Romford, RM1 3PJ
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Shipley, BD18 3SA
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Sidcup, DA14 6LT
Research Site
Wokingham, RG40 1XS

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About this study

Official title: A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)

Read the detailed description

A randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations over a 52-week treatment period in subjects with moderate to very severe COPD.

Conditions: COPD
Being tested: BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg, BGF MDI 160/14.4/9.6 μg, BFF MDI 320/9.6 μg
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.

BGF MDI 320/14.4/9.6 μgDrug
Also called BGF
Budensonide, Glycopyrronium, and Formoterol Fumarate
GFF MDI 14.4/9.6 μgDrug
Also called GFF
Glycopyrronium, and Formoterol Fumarate
BGF MDI 160/14.4/9.6 μgDrug
Also called BGF
Budensonide, Glycopyrronium, and Formoterol Fumarate
BFF MDI 320/9.6 μgDrug
Also called BFF
Budensonide, and Formoterol Fumarate

Study groups in NCT02465567
Study group	Role	What they receive
BGF (PT010) MDI 320/14.4/9.6 μg	Experimental	BGF MDI 320/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler [MDI]) Receives: Drug: BGF MDI 320/14.4/9.6 μg
BGF (PT010) MDI 160/14.4/9.6 μg	Experimental	BGF MDI 160/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler [MDI]) Receives: Drug: BGF MDI 160/14.4/9.6 μg
BFF (PT009) MDI 320/9.6 μg	Experimental	BFF MDI 320/9.6 μg Budesonide, Formoterol Fumarate Aerosol Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT009) Receives: Drug: BFF MDI 320/9.6 μg
GFF (PT003) MDI 14.4/9.6 μg	Experimental	GFF MDI 14.4/9.6 μg Glycopyrronium, Formoterol Fumarate Aerosol Budesonide and Formoterol Fumarate Inhalation Aerosol (PT003) Receives: Drug: GFF MDI 14.4/9.6 μg

What is being measured

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

Adjusted Rate of Moderate or Severe Exacerbations
Adjusted Rate of Moderate or Severe Exacerbations
Measured: 52-week treatment period

Secondary outcomes (5)

Time to First Moderate or Severe COPD Exacerbation
Time to first moderate or severe COPD exacerbation (proportion with event reported as median time was not reached, statistical analyses are based upon time to event)
Measured: 52 Weeks
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
Measured: 24 Weeks
Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score
Percentage of subjects achieving a minimal clinically important difference (MCID) of 4 units or more in SGRQ (St. George's Respiratory Questionnaire) total score at Week 24
Measured: at Week 24
Time to Death (All Cause)
Subject Deaths (all cause)
Measured: 52 Weeks
Rate of Severe COPD Exacerbations
Rate of severe COPD exacerbations
Measured: 52 Weeks

Timeline

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

30 Jun 201526 Jul 2019

First posted8 Jun 2015 (estimated)
Study start30 Jun 2015
Primary completion26 Jul 2019
Study completion26 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for COPDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 8,588 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02465567
Sponsor's protocol ID: PT010005
Status last verified: Jan 2021
First submitted: 29 May 2015
Last updated: 2 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Deslee G, Russo H, Fabry-Vendrand C, Koskas D, Thabut G, Bell JP, Caplen M, Bhatt PD, Carioto J, Pyenson B, Burgel PR. Impact of Increased Use of Single-Inhaler Triple Therapies on COPD Exacerbation Rates, Mortality, and Total Costs: PROMETHEUS France. Int J Chron Obstruct Pulmon Dis. 2025 Nov 17;20:3753-3763. doi: 10.2147/COPD.S539055. eCollection 2025.
PubMed 41281771
Muro S, Seki M, Hurst JR, Petullo D, Marshall J, Bowen K, Darken PF, Duncan EA, Megally A, Patel M. Triple Therapy with Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate versus Dual Therapies for Patients with COPD and Phenotypic Features of Asthma: A Pooled Post Hoc Analysis of KRONOS and ETHOS. Int J Chron Obstruct Pulmon Dis. 2024 Dec 12;19:2729-2737. doi: 10.2147/COPD.S478349. eCollection 2024.
PubMed 39691156
Singh D, Martinez FJ, Hurst JR, Han MK, Gale CP, Fredriksson M, Kisielewicz D, Mushunje A, Movitz C, Ojili N, Parikh H, Arya N, Bowen K, Patel M. Effect of Triple Therapy on Cardiovascular and Severe Cardiopulmonary Events in Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis of a Randomized, Double-Blind, Phase 3 Clinical Trial (ETHOS). Am J Respir Crit Care Med. 2025 Feb;211(2):205-214. doi: 10.1164/rccm.202312-2311OC.
PubMed 39213002
Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
PubMed 35815359
Rhodes K, Jenkins M, de Nigris E, Aurivillius M, Ouwens M. Relationship between risk, cumulative burden of exacerbations and mortality in patients with COPD: modelling analysis using data from the ETHOS study. BMC Med Res Methodol. 2022 May 25;22(1):150. doi: 10.1186/s12874-022-01616-7.
PubMed 35614467
Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Aurivillius M, Reisner C, Dorinsky P; ETHOS Investigators. Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD. N Engl J Med. 2020 Jul 2;383(1):35-48. doi: 10.1056/NEJMoa1916046. Epub 2020 Jun 24.
PubMed 32579807
Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Reisner C, Dorinsky P. A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 mug and 160/18/9.6 mug using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol. Respir Med. 2019 Oct-Nov;158:59-66. doi: 10.1016/j.rmed.2019.08.010. Epub 2019 Aug 22.
PubMed 31605923

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)
ClinicalTrials.gov ID: NCT02465567
Acronym / sponsor ID: PT010005
Conditions: COPD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 8,588 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 30 Jun 2015 (actual)
Primary completion: 26 Jul 2019 (actual)
Study completion: 26 Jul 2019 (actual)
First posted: 8 Jun 2015 (estimated)
Results: Posted 2 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
BGF (PT010) MDI 320/14.4/9.6 μg	Experimental	Drug: BGF MDI 320/14.4/9.6 μgBGF MDI 320/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler [MDI])
BGF (PT010) MDI 160/14.4/9.6 μg	Experimental	Drug: BGF MDI 160/14.4/9.6 μgBGF MDI 160/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler [MDI])
BFF (PT009) MDI 320/9.6 μg	Experimental	Drug: BFF MDI 320/9.6 μgBFF MDI 320/9.6 μg Budesonide, Formoterol Fumarate Aerosol Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT009)
GFF (PT003) MDI 14.4/9.6 μg	Experimental	Drug: GFF MDI 14.4/9.6 μgGFF MDI 14.4/9.6 μg Glycopyrronium, Formoterol Fumarate Aerosol Budesonide and Formoterol Fumarate Inhalation Aerosol (PT003)

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS),
Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <65% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).
Subjects with history of exacerbations.

Key exclusion criteria (9 listed)

Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening)
Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BGF MDI 320/14.4/9.6 μgAlso: BGFBudensonide, Glycopyrronium, and Formoterol Fumarate	Drug	BGF (PT010) MDI 320/14.4/9.6 μg
GFF MDI 14.4/9.6 μgAlso: GFFGlycopyrronium, and Formoterol Fumarate	Drug	GFF (PT003) MDI 14.4/9.6 μg
BGF MDI 160/14.4/9.6 μgAlso: BGFBudensonide, Glycopyrronium, and Formoterol Fumarate	Drug	BGF (PT010) MDI 160/14.4/9.6 μg
BFF MDI 320/9.6 μgAlso: BFFBudensonide, and Formoterol Fumarate	Drug	BFF (PT009) MDI 320/9.6 μg

Primary outcome

Adjusted Rate of Moderate or Severe Exacerbations
Time frame: 52-week treatment period
Adjusted Rate of Moderate or Severe Exacerbations

5 secondary outcomes

Time to First Moderate or Severe COPD Exacerbation
Time frame: 52 Weeks
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks
Time frame: 24 Weeks
Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score
Time frame: at Week 24
Time to Death (All Cause)
Time frame: 52 Weeks
Rate of Severe COPD Exacerbations
Time frame: 52 Weeks

Results and safety

Results posted to the registry on 2 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BGF MDI 320/14.4/9.6 μg	2,157	1,708
BGF MDI 160/14.4/9.6 μg	2,137	1,713
GFF MDI 14.4/9.6 μg	2,143	1,580
BFF MDI 320/9.6 μg	2,151	1,643

Primary outcome: Adjusted Rate of Moderate or Severe Exacerbations

Time frame: 52-week treatment period. Least squares mean (Standard Error). Unit: Moderate or Severe Exacerbations

Measure	BGF MDI 320/14.4/9.6 μg n = 2137	BGF MDI 160/14.4/9.6 μg n = 2121	GFF MDI 14.4/9.6 μg n = 2120	BFF MDI 320/9.6 μg n = 2131
Value	1.08 (0.04)	1.07 (0.04)	1.42 (0.05)	1.24 (0.04)

BGF MDI 320/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg: Rate Ratio: 0.76 (95% CI 0.69 to 0.83), p <0.0001, Negative Binomial Regression
BGF MDI 320/14.4/9.6 μg vs BFF MDI 320/9.6 μg: Rate Ratio: 0.87 (95% CI 0.79 to 0.95), p = 0.0027, Negative Binomial Regression
BGF MDI 160/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg: Rate Ratio: 0.75 (95% CI 0.69 to 0.83), p <0.0001, Negative Binomial Regression

Population analysed: mITT Population

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BGF MDI 320/14.4/9.6 μg	426 of 2,144 (19.9%)	337 of 2,144 (15.7%)	27 of 2,144
BGF MDI 160/14.4/9.6 μg	445 of 2,124 (21%)	361 of 2,124 (17%)	42 of 2,124
GFF MDI 14.4/9.6 μg	433 of 2,125 (20.4%)	292 of 2,125 (13.7%)	47 of 2,125
BFF MDI 320/9.6 μg	440 of 2,136 (20.6%)	336 of 2,136 (15.7%)	35 of 2,136

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41281771Deslee G, Russo H, Fabry-Vendrand C, Koskas D, Thabut G, Bell JP, Caplen M, Bhatt PD, Carioto J, Pyenson B, Burgel PR. Impact of Increased Use of Single-Inhaler Triple Therapies on COPD Exacerbation Rates, Mortality, and Total Costs: PROMETHEUS France. Int J Chron Obstruct Pulmon Dis. 2025 Nov 17;20:3753-3763. doi: 10.2147/COPD.S539055. eCollection 2025.
Derived from this study: PubMed 39691156Muro S, Seki M, Hurst JR, Petullo D, Marshall J, Bowen K, Darken PF, Duncan EA, Megally A, Patel M. Triple Therapy with Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate versus Dual Therapies for Patients with COPD and Phenotypic Features of Asthma: A Pooled Post Hoc Analysis of KRONOS and ETHOS. Int J Chron Obstruct Pulmon Dis. 2024 Dec 12;19:2729-2737. doi: 10.2147/COPD.S478349. eCollection 2024.
Derived from this study: PubMed 39213002Singh D, Martinez FJ, Hurst JR, Han MK, Gale CP, Fredriksson M, Kisielewicz D, Mushunje A, Movitz C, Ojili N, Parikh H, Arya N, Bowen K, Patel M. Effect of Triple Therapy on Cardiovascular and Severe Cardiopulmonary Events in Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis of a Randomized, Double-Blind, Phase 3 Clinical Trial (ETHOS). Am J Respir Crit Care Med. 2025 Feb;211(2):205-214. doi: 10.1164/rccm.202312-2311OC.
Derived from this study: PubMed 35815359Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
Derived from this study: PubMed 35614467Rhodes K, Jenkins M, de Nigris E, Aurivillius M, Ouwens M. Relationship between risk, cumulative burden of exacerbations and mortality in patients with COPD: modelling analysis using data from the ETHOS study. BMC Med Res Methodol. 2022 May 25;22(1):150. doi: 10.1186/s12874-022-01616-7.
Derived from this study: PubMed 32579807Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Aurivillius M, Reisner C, Dorinsky P; ETHOS Investigators. Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD. N Engl J Med. 2020 Jul 2;383(1):35-48. doi: 10.1056/NEJMoa1916046. Epub 2020 Jun 24.
Derived from this study: PubMed 31605923Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Reisner C, Dorinsky P. A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 mug and 160/18/9.6 mug using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol. Respir Med. 2019 Oct-Nov;158:59-66. doi: 10.1016/j.rmed.2019.08.010. Epub 2019 Aug 22.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul M Dorinsky, MD study director

Pearl Therapeutics

741 sites in 26 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg and BGF MDI 160/14.4/9.6 μg in people with COPD, run by Pearl Therapeutics, Inc. at 741 sites in 26 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 6 inclusion and 9 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 741 sites in United States, Germany, China, Argentina, Spain and 21 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?

Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Adjusted Rate of Moderate or Severe Exacerbations (time frame: 52-week treatment period). 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 NCT02465567, which also lists 7 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 2 Feb 2021.