Chronic Obstructive Pulmonary DisorderPhase 3telosNCT02766608
Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD
A Phase 3 study testing BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg and FF MDI 9.6 μg in people with Chronic Obstructive Pulmonary Disorder, run by Pearl Therapeutics, Inc. at 259 sites in 8 countries.
Trial summary
This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disorder
- What is being tested?
- BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg and FF MDI 9.6 μg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,389 participants
- Where
- 259 sitesin 8 countries
- Study dates
- 31 May 2016to 1 Dec 2017
- 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
- Give their signed written informed consent to participate
- Are at least 40 years of age and no older than 80 years
- COPD patients who are symptomatic
- Must be receiving one or more inhaled bronchodilators as maintenance therapy
Who cannot join
- Current diagnosis of asthma,
- COPD due to α1-Antitrypsin Deficiency
- Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months
- Long-term-oxygen therapy (≥ 12 hours a day).
Trial locations and contacts
259 sites in 8 countries.
259 sites in 8 countries
United States83 sites
Research Site
Anaheim, California, 92801
Research Site
Anderson, South Carolina, 29621
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Athens, Alabama, 35611
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Bellevue, Washington, 98004
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Bellevue, Washington, 98007
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Birmingham, Alabama, 35243
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Blue Ridge, Georgia, 30513
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Boulder, Colorado, 80301
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Channelview, Texas, 77530
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Charlotte, North Carolina, 28207
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Clearwater, Florida, 33756
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Clearwater, Florida, 33765
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Colorado Springs, Colorado, 80907
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Columbus, Ohio, 43213
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Columbus, Ohio, 43215
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Dayton, Ohio, 45459
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DeLand, Florida, 32720
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Dothan, Alabama, 36305
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Dublin, Ohio, 43016
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Easley, South Carolina, 29640
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Edina, Minnesota, 55435
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Fargo, North Dakota, 58103
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Farmington Hills, Michigan, 48336
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Fridley, Minnesota, 55432
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Gaffney, South Carolina, 29341
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Gastonia, North Carolina, 28054
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Gold River, California, 95670
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Greensboro, North Carolina, 27408
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Greenville, South Carolina, 29615
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Grove City, Ohio, 43123
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Hamden, Connecticut, 06517
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Henderson, Nevada, 89014
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Henderson, Nevada, 89052
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Hialeah, Florida, 33016
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Huntersville, North Carolina, 28078
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Jackson Heights, New York, 11236
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Johnson City, Tennessee, 37601
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Kingsport, Tennessee, 37660
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Larchmont, New York, 10803
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Las Vegas, Nevada, 89118
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Littleton, Colorado, 80127
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Live Oak, Texas, 78233
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Medford, Oregon, 97504
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Meridian, Idaho, 83646
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Miami, Florida, 33134
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Miami, Florida, 33175
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Miami, Florida, 33186
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Minneapolis, Minnesota, 55407
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Mt. Pleasant, South Carolina, 29464
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New Braunfels, Texas, 78130
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Newport News, Virginia, 23606
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North Dartmouth, Massachusetts, 02747
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Oklahoma City, Oklahoma, 73103
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Old Point Station, South Carolina, 29707
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Palm Springs, California, 92262
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Panama City, Florida, 32405
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Phoenix, Arizona, 85006
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Phoenix, Arizona, 85020
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Pittsburgh, Pennsylvania, 15236
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Pittsburgh, Pennsylvania, 15243
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Port Orange, Florida, 32127
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Port Orange, Florida, 32129
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Richmond, Virginia, 23294
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Rock Hill, South Carolina, 29732
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Sacramento, California, 95823
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Saint Charles, Missouri, 63301
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San Antonio, Texas, 78212
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San Antonio, Texas, 78229
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San Diego, California, 92120
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Seneca, South Carolina, 29678
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South Burlington, Vermont, 05403
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Spartanburg, South Carolina, 29303
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St Louis, Missouri, 63141
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Sugar Land, Texas, 77479
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Tacoma, Washington, 98405
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Tampa, Florida, 33603
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Towson, Maryland, 21204
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Tucson, Arizona, 85745
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Union, South Carolina, 29379
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Westminster, Maryland, 21157
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Winston-Salem, North Carolina, 27103
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Winter Park, Florida, 32789-4681
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Woodbury, Minnesota, 55125
Russia47 sites
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Barnaul, 656045
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Chelyabinsk, 454106
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Ivanovo, 153005
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Izhevsk, 426035
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Kazan', 420008
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Kazan', 420012
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Kirov, 610027
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Moscow, 119991
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Moscow, 123423
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Moscow, 123995
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Moscow, 125315
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Moscow, 129090
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Nizhny Novgorod, 603126
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Novosibirsk, 630008
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Novosibirsk, 630051
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Novosibirsk, 630084
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Novosibirsk, 630087
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Omsk, 644043
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Omsk, 644112
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Penza, 440026
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Penza, 440067
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Perm, 614000
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Pytigorsk, 357538
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Rostov-on-Don, 344068
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Ryazan, 390026
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Saint Petersburg, 193231
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Saint Petersburg, 194044
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Saint Petersburg, 194291
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Saint Petersburg, 194354
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Saint Petersburg, 196084
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Saint Petersburg, 196143
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Saint Petersburg, 196247
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Saint Petersburg, 196601
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Saint Petersburg, 197022
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Saint Petersburg, 197089
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Saint Petersburg, 197342
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Saint Petersburg, 198260
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Saratov, 410012
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Smolensk, 214006
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Smolensk, 214019
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Ulyanovsk, 432009
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Vladimir, 600023
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Voronezh, 394066
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Yaroslavl, 150002
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Yaroslavl, 150062
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Yekaterinburg, 620039
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Yekaterinburg, 620149
Poland42 sites
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Bialystok, 15-003
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Bialystok, 15-044
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Bialystok, 15-430
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Bielsko-Biala, 43-300
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Chełm, 22-100
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Elblag, 82-300
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Gdansk, 80-952
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Grudziądz, 86-300
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Katowice, 40-648
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Kościan, 64-000
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Krakow, 30-901
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Krakow, 31-159
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Legnica, 59-220
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Lodz, 90-141
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Lodz, 91-363
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Lublin, 20-093
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Nowy Duninów, 09-505
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Ostrów Wielkopolski, 63-400
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Ostrowiec Świętokrzyski, 27-400
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Piekary Śląskie, 41-94O
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Piła, 64-920
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Poznan, 60-685
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Poznan, 60-693
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Poznan, 60-823
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Proszowice, 32-100
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Puławy, 24-100
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Ruda Śląska, 41-709
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Rzeszów, 35-051
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Rzeszów, 35-205
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Siedlce, 08-110
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Sochaczew, 96-500
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Suwałki, 16-400
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Szczecin, 70-111
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Tarnów, 33-100
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Trzebnica, 55-100
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Warsaw, 01-518
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Warsaw, 02-777
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Wieluń, 98-300
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Wołomin, 05-200
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Wroclaw, 53-301
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Zabrze, 41-800
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Zamość, 22-400
Canada20 sites
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Ajax, Ontario, L1S 2J5
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Burlington, Ontario, L7M 4Y1
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Edmonton, Alberta, T6L 5X8
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Greater Sudbury, Ontario, P3A 1W8
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Mirabel, Quebec, J7J 2K8
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Montreal, Quebec, H1M 1B1
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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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Québec, Quebec, G3K 2P8
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Québec, G1W 4R4
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Saint-Charles-Borromée, Quebec, J6E 2B4
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Saskatoon, Saskatchewan, S7N 0W8
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Toronto, Ontario, M3J 2C5
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Trois-Rivières, Quebec, G8T 7A1
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Truro, Nova Scotia, B2N 1L2
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Victoriaville, Quebec, G6P 6P6
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Windsor, Ontario, N8X 1T3
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Windsor, Ontario, N8X 5A6
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Winnipeg, Manitoba, R2K 3S8
Czechia18 sites
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Boskovice, 680 01
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Brandýs nad Labem, 250 01
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Jindřichův Hradec, 37701
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Liberec, 525947
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Lovosice, 410 02
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Nový Bor, 473 01
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Ostrava-Hrabuvka, 700 30
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Ostrava-Poruba, 708 68
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Prague, 140 00
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Prague, 140 59
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Prague, 15000
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Prague, 16900
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Prague, 190 00
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Rokycany, 337 22
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Strakonice, 38601
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Teplice, 415 01
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Varnsdorf, 407 47
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Žatec, 43801
Germany18 sites
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Bamberg, 96049
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Berlin, 10119
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Berlin, 10629
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Berlin, 10787
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Berlin, 12157
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Berlin, 13156
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Berlin, 14059
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Cologne, 51069
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Darmstadt, 64283
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Essen, 45355
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Frankfurt, 60596
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Hamburg, 20253
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Hamburg, 20354
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Leipzig, 04109
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Leipzig, 04207
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Lübeck, 23552
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Rodgau-Dudenhofen, 63110
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Schwerin, 19055
Hungary17 sites
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Balassagyarmat, 2660
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Budapest, 1135
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Cegléd, 2700
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Csorna, 9300
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Gödöllő, 2100
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Hajdúnánás, 4080
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Hatvan, 3000
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Komárom, 2900
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Makó, 6900
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Miskolc, 3529
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Nyíregyháza, 4400
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Pécs, 7626
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Pécs, 7635
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Siófok, 8600
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Százhalombatta, 2440
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Szeged, H-6722
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Szolnok, 5000
South Korea14 sites
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Anyang-si, 14068
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Busan, 49201
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Incheon, 21431
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Jeonju, 54907
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Seongnam-si, 13620
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Seoul, 02559
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Seoul, 02841
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Seoul, 03080
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Seoul, 03181
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Seoul, 03722
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Seoul, 04401
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Seoul, 04551
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Seoul, 06591
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Seoul, 08308
About this study
Official title: A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005, PT008, and Open-label Symbicort® Turbuhaler®, as an Active Control, on Lung Function Over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD
This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.
Read the detailed description
This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be to one of the following five treatment groups:BFF MDI 320/9.6 μg BID (N=660), BFF MDI 160/9.6 μg BID, FF MDI 9.6 μg BID, BD MDI 320 μg BID, Symbicort®, TBH 400/12 μg BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 24 weeks.
- Conditions
- Chronic Obstructive Pulmonary Disorder
- Being tested
- BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg, FF MDI 9.6 μg, BD MDI 320 μg, Symbicort® TBH 400/12 μg BID
- Keywords
- COPD
- 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.
BFF MDI 320/9.6 μgDrug
Also called Budesonide and Formoterol Fumarate Inhalation Aerosol
Blinded Treatment
BFF MDI 160/9.6 μgDrug
Also called Budesonide and Formoterol Fumarate Inhalation Aerosol
Blinded Treatment
FF MDI 9.6 μgDrug
Also called Formoterol Fumarate Inhalation Aerosol
Blinded Treatment
BD MDI 320 μgDrug
Also called Budesonide Inhalation Aerosol
Blinded Treatment
Symbicort® TBH 400/12 μg BIDDrug
Also called Symbicort® Turbuhaler
Open Label
| Study group | Role | What they receive |
|---|---|---|
| BFF MDI 320/9.6 μg | Experimental | Budesonide and Formoterol Fumarate Inhalation Aerosol 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID Receives: Drug: BFF MDI 320/9.6 μg |
| BFF MDI 160/9.6 μg | Experimental | Budesonide and Formoterol Fumarate Inhalation Aerosol-80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID Receives: Drug: BFF MDI 160/9.6 μg |
| FF MDI 9.6 μg | Experimental | Formoterol Fumarate Inhalation Aerosol-4.8 μg per actuation MDI/ 120 inhalations Taken as 2 inhalations BID Receives: Drug: FF MDI 9.6 μg |
| BD MDI 320 μg | Experimental | Budesonide inhalation Aerosol 160 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID Receives: Drug: BD MDI 320 μg |
| Symbicort® TBH 400/12 μg | Other | Symbicort Turbuhaler 400/12 μg Taken as 2 inhalations BID Receives: Drug: Symbicort® TBH 400/12 μg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI)
Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI)
Measured: at Week 24
Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI)
Changes from baseline in FEV1 AUC0-4 were normalized by taking the area under the curve value and dividing by the length of time under consideration (usually 4 hours). This normalization represents a weighted average of the change from baseline in FEV1 over the 4-hour period.
Measured: at Week 24
Secondary outcomes (11)
Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI).
Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation (BFF MDI vs FF MDI).
Measured: over 24 Weeks (timepoints of 4, 12 & 20 weeks)
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24
The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI, FF MDI, BD MDI, \& Symbicort TBH on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.
Measured: at Week 24
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI)
Change from baseline in morning pre-dose trough FEV1(Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)
Measured: at Week 24
Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI)
Peak change from baseline in FEV1 (Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)
Measured: at Week 24
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI)
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks (BFF MDI vs BD MDI)
Measured: over 24 Weeks
FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Measured: Day 1 - 5 Minutes
FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Measured: Day 1 - 15 Minutes
FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Measured: Day 1 - 30 Minutes
FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Measured: Day 1 - 1 Hour
FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Measured: Day 1 - 2 Hours
FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Measured: Day 1 - 4 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study start31 May 2016
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
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 (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DisorderStudies 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
- 2,389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766608
- Sponsor's protocol ID
- PT009002
- Acronym
- telos
- Status last verified
- Jul 2019
- First submitted
- 6 May 2016
- Last updated
- 24 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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 35815359Ferguson GT, Papi A, Anzueto A, Kerwin EM, Cappelletti C, Duncan EA, Nyberg J, Dorinsky P. Budesonide/formoterol MDI with co-suspension delivery technology in COPD: the TELOS study. Eur Respir J. 2018 Sep 16;52(3):1801334. doi: 10.1183/13993003.01334-2018. Print 2018 Sep.
PubMed 30220648
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005, PT008, and Open-label Symbicort® Turbuhaler®, as an Active Control, on Lung Function Over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD
- ClinicalTrials.gov ID
- NCT02766608
- Acronym / sponsor ID
- telos / PT009002
- Conditions
- Chronic Obstructive Pulmonary Disorder
- Keywords
- COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,389 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 10 May 2016 (estimated)
- Results
- Posted 24 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.
Detailed description
This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be to one of the following five treatment groups:BFF MDI 320/9.6 μg BID (N=660), BFF MDI 160/9.6 μg BID, FF MDI 9.6 μg BID, BD MDI 320 μg BID, Symbicort®, TBH 400/12 μg BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BFF MDI 320/9.6 μg | Experimental | Drug: BFF MDI 320/9.6 μgBudesonide and Formoterol Fumarate Inhalation Aerosol 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID |
| BFF MDI 160/9.6 μg | Experimental | Drug: BFF MDI 160/9.6 μgBudesonide and Formoterol Fumarate Inhalation Aerosol-80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID |
| FF MDI 9.6 μg | Experimental | Drug: FF MDI 9.6 μgFormoterol Fumarate Inhalation Aerosol-4.8 μg per actuation MDI/ 120 inhalations Taken as 2 inhalations BID |
| BD MDI 320 μg | Experimental | Drug: BD MDI 320 μgBudesonide inhalation Aerosol 160 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID |
| Symbicort® TBH 400/12 μg | Other | Drug: Symbicort® TBH 400/12 μg BIDSymbicort Turbuhaler 400/12 μg Taken as 2 inhalations BID |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Give their signed written informed consent to participate
- Are at least 40 years of age and no older than 80 years
- COPD patients who are symptomatic
- Must be receiving one or more inhaled bronchodilators as maintenance therapy
Key exclusion criteria (4 listed)
- Current diagnosis of asthma,
- COPD due to α1-Antitrypsin Deficiency
- Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months
- Long-term-oxygen therapy (≥ 12 hours a day).
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 |
|---|---|---|
| BFF MDI 320/9.6 μgAlso: Budesonide and Formoterol Fumarate Inhalation AerosolBlinded Treatment | Drug | BFF MDI 320/9.6 μg |
| BFF MDI 160/9.6 μgAlso: Budesonide and Formoterol Fumarate Inhalation AerosolBlinded Treatment | Drug | BFF MDI 160/9.6 μg |
| FF MDI 9.6 μgAlso: Formoterol Fumarate Inhalation AerosolBlinded Treatment | Drug | FF MDI 9.6 μg |
| BD MDI 320 μgAlso: Budesonide Inhalation AerosolBlinded Treatment | Drug | BD MDI 320 μg |
| Symbicort® TBH 400/12 μg BIDAlso: Symbicort® TurbuhalerOpen Label | Drug | Symbicort® TBH 400/12 μg |
Primary outcome
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI)
Time frame: at Week 24
Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI)
Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI)
Time frame: at Week 24
Changes from baseline in FEV1 AUC0-4 were normalized by taking the area under the curve value and dividing by the length of time under consideration (usually 4 hours). This normalization represents a weighted average of the change from baseline in FEV1 over the 4-hour period.
11 secondary outcomes
Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI).
Time frame: over 24 Weeks (timepoints of 4, 12 & 20 weeks)
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24
Time frame: at Week 24
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI)
Time frame: at Week 24
Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI)
Time frame: at Week 24
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI)
Time frame: over 24 Weeks
FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination
Time frame: Day 1 - 5 Minutes
FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination
Time frame: Day 1 - 15 Minutes
FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination
Time frame: Day 1 - 30 Minutes
FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination
Time frame: Day 1 - 1 Hour
FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination
Time frame: Day 1 - 2 Hours
FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination
Time frame: Day 1 - 4 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 30220648Ferguson GT, Papi A, Anzueto A, Kerwin EM, Cappelletti C, Duncan EA, Nyberg J, Dorinsky P. Budesonide/formoterol MDI with co-suspension delivery technology in COPD: the TELOS study. Eur Respir J. 2018 Sep 16;52(3):1801334. doi: 10.1183/13993003.01334-2018. Print 2018 Sep.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
259 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg and FF MDI 9.6 μg in people with Chronic Obstructive Pulmonary Disorder, run by Pearl Therapeutics, Inc. at 259 sites in 8 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 4 inclusion and 4 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 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 259 sites in United States, Russia, Poland, Canada, Czechia and 3 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 24 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI) (time frame: at Week 24). The study lists 2 primary outcomes in all. 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 NCT02766608, which also lists 2 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 24 Sep 2019.