Clinical trial NCT02766608: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disorder
Keywords: COPD
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-10
Enrollment: 2389
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Give their signed written informed consent to participate
2. Are at least 40 years of age and no older than 80 years
3. COPD patients who are symptomatic
4. Must be receiving one or more inhaled bronchodilators as maintenance therapy

Exclusion Criteria:

1. Current diagnosis of asthma,
2. COPD due to α1-Antitrypsin Deficiency
3. Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months
4. Long-term-oxygen therapy (≥ 12 hours a day).

Primary outcomes:
measure: Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI)
timeFrame: at Week 24
measure: Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI)
timeFrame: at Week 24
Secondary outcomes:
measure: Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI).
timeFrame: over 24 Weeks (timepoints of 4, 12 & 20 weeks)
measure: Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24
timeFrame: at Week 24
measure: Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI)
timeFrame: at Week 24
measure: Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI)
timeFrame: at Week 24
measure: Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI)
timeFrame: over 24 Weeks
measure: FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination
timeFrame: Day 1 - 5 Minutes
measure: FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination
timeFrame: Day 1 - 15 Minutes
measure: FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination
timeFrame: Day 1 - 30 Minutes
measure: FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination
timeFrame: Day 1 - 1 Hour
measure: FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination
timeFrame: Day 1 - 2 Hours
measure: FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination
timeFrame: Day 1 - 4 Hours
Other outcomes:
measure: Substudy: 12-hour PFT Endpoint FEV1 AUC0-12
timeFrame: at Week 12
Locations:
city: Athens
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Dothan
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Anaheim
country: United States
facility: Research Site
state: California
city: Gold River
country: United States
facility: Research Site
state: California
city: Palm Springs
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Boulder
country: United States
facility: Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Littleton
country: United States
facility: Research Site
state: Colorado
city: Hamden
country: United States
facility: Research Site
state: Connecticut
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: DeLand
country: United States
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state: Florida
city: Hialeah
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Panama City
country: United States
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state: Florida
city: Port Orange
country: United States
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state: Florida
city: Port Orange
country: United States
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state: Florida
city: Tampa
country: United States
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state: Florida
city: Winter Park
country: United States
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state: Florida
city: Blue Ridge
country: United States
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state: Georgia
city: Meridian
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state: Idaho
city: Towson
country: United States
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state: Maryland
city: Westminster
country: United States
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state: Maryland
city: North Dartmouth
country: United States
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state: Massachusetts
city: Farmington Hills
country: United States
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state: Michigan
city: Edina
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state: Minnesota
city: Fridley
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state: Minnesota
city: Minneapolis
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state: Minnesota
city: Woodbury
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state: Minnesota
city: Saint Charles
country: United States
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state: Missouri
city: Saint Louis
country: United States
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city: Henderson
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state: Nevada
city: Henderson
country: United States
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city: Las Vegas
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city: Jackson Heights
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state: New York
city: Larchmont
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city: Charlotte
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state: North Carolina
city: Gastonia
country: United States
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state: North Carolina
city: Greensboro
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city: Huntersville
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city: Winston-Salem
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city: Fargo
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state: North Dakota
city: Columbus
country: United States
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state: Ohio
city: Columbus
country: United States
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city: Dayton
country: United States
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city: Dublin
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city: Grove City
country: United States
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city: Oklahoma City
country: United States
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city: Medford
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city: Pittsburgh
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state: Pennsylvania
city: Pittsburgh
country: United States
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city: Anderson
country: United States
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state: South Carolina
city: Easley
country: United States
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city: Gaffney
country: United States
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state: South Carolina
city: Greenville
country: United States
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state: South Carolina
city: Indian Land
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state: South Carolina
city: Mount Pleasant
country: United States
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state: South Carolina
city: Rock Hill
country: United States
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state: South Carolina
city: Seneca
country: United States
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city: Spartanburg
country: United States
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state: South Carolina
city: Union
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state: South Carolina
city: Johnson City
country: United States
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state: Tennessee
city: Kingsport
country: United States
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state: Tennessee
city: Channelview
country: United States
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state: Texas
city: Live Oak
country: United States
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state: Texas
city: New Braunfels
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Sugar Land
country: United States
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state: Texas
city: South Burlington
country: United States
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state: Vermont
city: Newport News
country: United States
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state: Virginia
city: Richmond
country: United States
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state: Virginia
city: Bellevue
country: United States
facility: Research Site
state: Washington
city: Bellevue
country: United States
facility: Research Site
state: Washington
city: Tacoma
country: United States
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state: Washington
city: Edmonton
country: Canada
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state: Alberta
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Truro
country: Canada
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state: Nova Scotia
city: Ajax
country: Canada
facility: Research Site
state: Ontario
city: Burlington
country: Canada
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state: Ontario
city: Sudbury
country: Canada
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state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: Windsor
country: Canada
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state: Ontario
city: Windsor
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state: Ontario
city: Mirabel
country: Canada
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state: Quebec
city: Montreal
country: Canada
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state: Quebec
city: Pointe-Claire
country: Canada
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city: St Charles Borromee
country: Canada
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city: Trois-Rivières
country: Canada
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state: Quebec
city: Victoriaville
country: Canada
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city: Saskatoon
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state: Saskatchewan
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facility: Research Site
city: Boskovice
country: Czechia
facility: Research Site
city: Brandys nad Labem
country: Czechia
facility: Research Site
city: Jindrichuv Hradec
country: Czechia
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city: Liberec
country: Czechia
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city: Lovosice
country: Czechia
facility: Research Site
city: Novy Bor
country: Czechia
facility: Research Site
city: Ostrava-Hrabuvka
country: Czechia
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city: Ostrava-Poruba
country: Czechia
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city: Prague
country: Czechia
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city: Praha 6
country: Czechia
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city: Praha 9
country: Czechia
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city: Praha
country: Czechia
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city: Praha
country: Czechia
facility: Research Site
city: Rokycany
country: Czechia
facility: Research Site
city: Strakonice
country: Czechia
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city: Teplice
country: Czechia
facility: Research Site
city: Varnsdorf
country: Czechia
facility: Research Site
city: Zatec
country: Czechia
facility: Research Site
city: Bamberg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Darmstadt
country: Germany
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city: Essen
country: Germany
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city: Frankfurt
country: Germany
facility: Research Site
city: Hamburg
country: Germany
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city: Hamburg
country: Germany
facility: Research Site
city: Köln
country: Germany
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city: Leipzig
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Lübeck
country: Germany
facility: Research Site
city: Rodgau-Dudenhofen
country: Germany
facility: Research Site
city: Schwerin
country: Germany
facility: Research Site
city: Balassagyarmat
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Cegléd
country: Hungary
facility: Research Site
city: Csorna
country: Hungary
facility: Research Site
city: Gödöllő
country: Hungary
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city: Hajdúnánás
country: Hungary
facility: Research Site
city: Hatvan
country: Hungary
facility: Research Site
city: Komárom
country: Hungary
facility: Research Site
city: Makó
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Nyíregyháza
country: Hungary
facility: Research Site
city: Pécs
country: Hungary
facility: Research Site
city: Pécs
country: Hungary
facility: Research Site
city: Siófok
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Százhalombatta
country: Hungary
facility: Research Site
city: Anyang-si
country: Korea, Republic of
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Jeonju-si
country: Korea, Republic of
facility: Research Site
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Bielsko-Biała
country: Poland
facility: Research Site
city: Chełm
country: Poland
facility: Research Site
city: Elbląg
country: Poland
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Grudziądz
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Kościan
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Legnica
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Nowy Duninow
country: Poland
facility: Research Site
city: Ostrowiec Świętokrzyski
country: Poland
facility: Research Site
city: Ostrów Wielkopolski
country: Poland
facility: Research Site
city: Piekary Śląskie
country: Poland
facility: Research Site
city: Pila
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Proszowice
country: Poland
facility: Research Site
city: Puławy
country: Poland
facility: Research Site
city: Ruda Slaska
country: Poland
facility: Research Site
city: Rzeszów
country: Poland
facility: Research Site
city: Rzeszów
country: Poland
facility: Research Site
city: Siedlce
country: Poland
facility: Research Site
city: Sochaczew
country: Poland
facility: Research Site
city: Suwałki
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Tarnów
country: Poland
facility: Research Site
city: Trzebnica
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wieluń
country: Poland
facility: Research Site
city: Wołomin
country: Poland
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Zamość
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Ivanovo
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kirov
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Penza
country: Russian Federation
facility: Research Site
city: Penza
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Pytigorsk
country: Russian Federation
facility: Research Site
city: Rostov-na-Donu
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: St-Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Ulyanovsk
country: Russian Federation
facility: Research Site
city: Vladimir
country: Russian Federation
facility: Research Site
city: Voronezh
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Yekaterinburg
country: Russian Federation
facility: Research Site
city: Yekaterinburg
country: Russian Federation
facility: Research Site
Study officials:
References:
citation: 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.
citation: Ferguson 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.