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
telos
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
1 other identifier
interventional
2,389
8 countries
259
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2016
259 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2016
CompletedFirst Posted
Study publicly available on registry
May 10, 2016
CompletedStudy Start
First participant enrolled
May 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedResults Posted
Study results publicly available
September 24, 2019
CompletedSeptember 24, 2019
July 1, 2019
1.5 years
May 6, 2016
November 30, 2018
September 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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.
at Week 24
Secondary Outcomes (11)
Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI).
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
at Week 24
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI)
at Week 24
Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI)
at Week 24
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI)
over 24 Weeks
- +6 more secondary outcomes
Other Outcomes (1)
Substudy: 12-hour PFT Endpoint FEV1 AUC0-12
at Week 12
Study Arms (5)
BFF MDI 320/9.6 μg
EXPERIMENTALBudesonide 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
EXPERIMENTALBudesonide and Formoterol Fumarate Inhalation Aerosol-80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
FF MDI 9.6 μg
EXPERIMENTALFormoterol Fumarate Inhalation Aerosol-4.8 μg per actuation MDI/ 120 inhalations Taken as 2 inhalations BID
BD MDI 320 μg
EXPERIMENTALBudesonide inhalation Aerosol 160 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Symbicort® TBH 400/12 μg
OTHERSymbicort Turbuhaler 400/12 μg Taken as 2 inhalations BID
Interventions
Blinded Treatment
Blinded Treatment
Blinded Treatment
Open Label
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (259)
Research Site
Athens, Alabama, 35611, United States
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Birmingham, Alabama, 35243, United States
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Dothan, Alabama, 36305, United States
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Phoenix, Arizona, 85006, United States
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Phoenix, Arizona, 85020, United States
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Tucson, Arizona, 85745, United States
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Anaheim, California, 92801, United States
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Gold River, California, 95670, United States
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Palm Springs, California, 92262, United States
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Sacramento, California, 95823, United States
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San Diego, California, 92120, United States
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Boulder, Colorado, 80301, United States
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Colorado Springs, Colorado, 80907, United States
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Littleton, Colorado, 80127, United States
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Hamden, Connecticut, 06517, United States
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Clearwater, Florida, 33756, United States
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Clearwater, Florida, 33765, United States
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DeLand, Florida, 32720, United States
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Hialeah, Florida, 33016, United States
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Miami, Florida, 33134, United States
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Miami, Florida, 33175, United States
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Miami, Florida, 33186, United States
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Panama City, Florida, 32405, United States
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Port Orange, Florida, 32127, United States
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Port Orange, Florida, 32129, United States
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Tampa, Florida, 33603, United States
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Winter Park, Florida, 32789-4681, United States
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Blue Ridge, Georgia, 30513, United States
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Meridian, Idaho, 83646, United States
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Towson, Maryland, 21204, United States
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Westminster, Maryland, 21157, United States
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North Dartmouth, Massachusetts, 02747, United States
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Farmington Hills, Michigan, 48336, United States
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Edina, Minnesota, 55435, United States
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Fridley, Minnesota, 55432, United States
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Minneapolis, Minnesota, 55407, United States
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Woodbury, Minnesota, 55125, United States
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Saint Charles, Missouri, 63301, United States
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St Louis, Missouri, 63141, United States
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Henderson, Nevada, 89014, United States
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Henderson, Nevada, 89052, United States
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Las Vegas, Nevada, 89118, United States
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Jackson Heights, New York, 11236, United States
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Larchmont, New York, 10803, United States
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Charlotte, North Carolina, 28207, United States
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Gastonia, North Carolina, 28054, United States
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Greensboro, North Carolina, 27408, United States
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Huntersville, North Carolina, 28078, United States
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Winston-Salem, North Carolina, 27103, United States
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Fargo, North Dakota, 58103, United States
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Columbus, Ohio, 43213, United States
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Columbus, Ohio, 43215, United States
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Dayton, Ohio, 45459, United States
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Dublin, Ohio, 43016, United States
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Grove City, Ohio, 43123, United States
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Oklahoma City, Oklahoma, 73103, United States
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Medford, Oregon, 97504, United States
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Pittsburgh, Pennsylvania, 15236, United States
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Pittsburgh, Pennsylvania, 15243, United States
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Anderson, South Carolina, 29621, United States
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Easley, South Carolina, 29640, United States
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Gaffney, South Carolina, 29341, United States
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Greenville, South Carolina, 29615, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Old Point Station, South Carolina, 29707, United States
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Rock Hill, South Carolina, 29732, United States
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Seneca, South Carolina, 29678, United States
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Spartanburg, South Carolina, 29303, United States
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Union, South Carolina, 29379, United States
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Johnson City, Tennessee, 37601, United States
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Kingsport, Tennessee, 37660, United States
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Channelview, Texas, 77530, United States
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Live Oak, Texas, 78233, United States
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New Braunfels, Texas, 78130, United States
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San Antonio, Texas, 78212, United States
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San Antonio, Texas, 78229, United States
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Sugar Land, Texas, 77479, United States
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South Burlington, Vermont, 05403, United States
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Newport News, Virginia, 23606, United States
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Richmond, Virginia, 23294, United States
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Bellevue, Washington, 98004, United States
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Bellevue, Washington, 98007, United States
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Tacoma, Washington, 98405, United States
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Edmonton, Alberta, T6L 5X8, Canada
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Winnipeg, Manitoba, R2K 3S8, Canada
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Truro, Nova Scotia, B2N 1L2, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Burlington, Ontario, L7M 4Y1, Canada
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Greater Sudbury, Ontario, P3A 1W8, Canada
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Toronto, Ontario, M3J 2C5, Canada
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Windsor, Ontario, N8X 1T3, Canada
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Windsor, Ontario, N8X 5A6, Canada
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Mirabel, Quebec, J7J 2K8, Canada
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Montreal, Quebec, H1M 1B1, Canada
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Pointe-Claire, Quebec, H9R 3J1, Canada
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Québec, Quebec, G1G 3Y8, Canada
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Québec, Quebec, G1V 4G5, Canada
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Québec, Quebec, G3K 2P8, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Trois-Rivières, Quebec, G8T 7A1, Canada
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Victoriaville, Quebec, G6P 6P6, Canada
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Saskatoon, Saskatchewan, S7N 0W8, Canada
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Québec, G1W 4R4, Canada
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Boskovice, 680 01, Czechia
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Brandýs nad Labem, 250 01, Czechia
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Jindřichův Hradec, 37701, Czechia
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Liberec, 525947, Czechia
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Lovosice, 410 02, Czechia
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Nový Bor, 473 01, Czechia
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Ostrava-Hrabuvka, 700 30, Czechia
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Ostrava-Poruba, 708 68, Czechia
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Prague, 140 00, Czechia
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Prague, 140 59, Czechia
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Prague, 15000, Czechia
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Prague, 16900, Czechia
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Prague, 190 00, Czechia
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Rokycany, 337 22, Czechia
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Strakonice, 38601, Czechia
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Teplice, 415 01, Czechia
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Varnsdorf, 407 47, Czechia
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Žatec, 43801, Czechia
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Bamberg, 96049, Germany
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Berlin, 10119, Germany
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Berlin, 10629, Germany
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Berlin, 10787, Germany
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Berlin, 12157, Germany
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Berlin, 13156, Germany
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Berlin, 14059, Germany
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Cologne, 51069, Germany
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Darmstadt, 64283, Germany
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Essen, 45355, Germany
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Frankfurt, 60596, Germany
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Hamburg, 20253, Germany
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Hamburg, 20354, Germany
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Leipzig, 04109, Germany
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Leipzig, 04207, Germany
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Lübeck, 23552, Germany
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Rodgau-Dudenhofen, 63110, Germany
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Schwerin, 19055, Germany
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Balassagyarmat, 2660, Hungary
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Budapest, 1135, Hungary
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Cegléd, 2700, Hungary
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Csorna, 9300, Hungary
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Gödöllő, 2100, Hungary
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Hajdúnánás, 4080, Hungary
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Hatvan, 3000, Hungary
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Komárom, 2900, Hungary
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Makó, 6900, Hungary
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Miskolc, 3529, Hungary
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Nyíregyháza, 4400, Hungary
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Pécs, 7626, Hungary
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Pécs, 7635, Hungary
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Siófok, 8600, Hungary
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Százhalombatta, 2440, Hungary
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Szeged, H-6722, Hungary
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Szolnok, 5000, Hungary
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Bialystok, 15-003, Poland
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Bialystok, 15-044, Poland
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Bialystok, 15-430, Poland
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Bielsko-Biala, 43-300, Poland
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Chełm, 22-100, Poland
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Elblag, 82-300, Poland
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Gdansk, 80-952, Poland
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Grudziądz, 86-300, Poland
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Katowice, 40-648, Poland
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Kościan, 64-000, Poland
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Krakow, 30-901, Poland
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Krakow, 31-159, Poland
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Legnica, 59-220, Poland
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Lodz, 90-141, Poland
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Lodz, 91-363, Poland
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Lublin, 20-093, Poland
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Nowy Duninów, 09-505, Poland
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Ostrowiec Świętokrzyski, 27-400, Poland
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Ostrów Wielkopolski, 63-400, Poland
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Piekary Śląskie, 41-94O, Poland
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Piła, 64-920, Poland
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Poznan, 60-685, Poland
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Poznan, 60-693, Poland
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Poznan, 60-823, Poland
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Proszowice, 32-100, Poland
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Puławy, 24-100, Poland
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Ruda Śląska, 41-709, Poland
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Rzeszów, 35-051, Poland
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Rzeszów, 35-205, Poland
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Siedlce, 08-110, Poland
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Sochaczew, 96-500, Poland
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Suwałki, 16-400, Poland
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Szczecin, 70-111, Poland
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Tarnów, 33-100, Poland
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Trzebnica, 55-100, Poland
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Warsaw, 01-518, Poland
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Warsaw, 02-777, Poland
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Wieluń, 98-300, Poland
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Wołomin, 05-200, Poland
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Wroclaw, 53-301, Poland
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Zabrze, 41-800, Poland
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Zamość, 22-400, Poland
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Barnaul, 656045, Russia
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Chelyabinsk, 454106, Russia
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Ivanovo, 153005, Russia
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Izhevsk, 426035, Russia
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Kazan', 420008, Russia
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Kazan', 420012, Russia
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Kirov, 610027, Russia
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Moscow, 119991, Russia
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Moscow, 123423, Russia
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Moscow, 123995, Russia
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Moscow, 125315, Russia
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Moscow, 129090, Russia
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Nizhny Novgorod, 603126, Russia
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Novosibirsk, 630008, Russia
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Novosibirsk, 630051, Russia
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Novosibirsk, 630084, Russia
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Novosibirsk, 630087, Russia
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Omsk, 644043, Russia
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Omsk, 644112, Russia
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Penza, 440026, Russia
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Penza, 440067, Russia
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Perm, 614000, Russia
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Pytigorsk, 357538, Russia
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Rostov-on-Don, 344068, Russia
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Ryazan, 390026, Russia
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Saint Petersburg, 193231, Russia
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Saint Petersburg, 194044, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 196084, Russia
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Saint Petersburg, 196143, Russia
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Saint Petersburg, 196247, Russia
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Saint Petersburg, 196601, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197089, Russia
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Saint Petersburg, 197342, Russia
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Saint Petersburg, 198260, Russia
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Saratov, 410012, Russia
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Smolensk, 214006, Russia
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Smolensk, 214019, Russia
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Ulyanovsk, 432009, Russia
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Vladimir, 600023, Russia
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Voronezh, 394066, Russia
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Yaroslavl, 150002, Russia
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Yaroslavl, 150062, Russia
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Yekaterinburg, 620039, Russia
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Yekaterinburg, 620149, Russia
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Anyang-si, 14068, South Korea
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Busan, 49201, South Korea
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Incheon, 21431, South Korea
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Jeonju, 54907, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 02559, South Korea
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Seoul, 02841, South Korea
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Seoul, 03080, South Korea
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Seoul, 03181, South Korea
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Seoul, 03722, South Korea
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Seoul, 04401, South Korea
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Seoul, 04551, South Korea
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Seoul, 06591, South Korea
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Seoul, 08308, South Korea
Related Publications (2)
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.
PMID: 35815359DERIVEDFerguson 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.
PMID: 30220648DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Paul M. Dorinsky, MD
- Organization
- Pearl Therapeutics, a Member of the AstraZeneca Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2016
First Posted
May 10, 2016
Study Start
May 31, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
September 24, 2019
Results First Posted
September 24, 2019
Record last verified: 2019-07