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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

NCT ID: NCT02766608

Last Updated: 2019-09-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-12-01

Brief Summary

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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.

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Detailed Description

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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

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Chronic Obstructive Pulmonary Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BFF MDI 320/9.6 μg

Budesonide and Formoterol Fumarate Inhalation Aerosol 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID

Group Type EXPERIMENTAL

BFF MDI 320/9.6 μg

Intervention Type DRUG

Blinded Treatment

BFF MDI 160/9.6 μg

Budesonide and Formoterol Fumarate Inhalation Aerosol-80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID

Group Type EXPERIMENTAL

BFF MDI 160/9.6 μg

Intervention Type DRUG

Blinded Treatment

FF MDI 9.6 μg

Formoterol Fumarate Inhalation Aerosol-4.8 μg per actuation MDI/ 120 inhalations Taken as 2 inhalations BID

Group Type EXPERIMENTAL

FF MDI 9.6 μg

Intervention Type DRUG

Blinded Treatment

BD MDI 320 μg

Budesonide inhalation Aerosol 160 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID

Group Type EXPERIMENTAL

BD MDI 320 μg

Intervention Type DRUG

Blinded Treatment

Symbicort® TBH 400/12 μg

Symbicort Turbuhaler 400/12 μg Taken as 2 inhalations BID

Group Type OTHER

Symbicort® TBH 400/12 μg BID

Intervention Type DRUG

Open Label

Interventions

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BFF MDI 320/9.6 μg

Blinded Treatment

Intervention Type DRUG

BFF MDI 160/9.6 μg

Blinded Treatment

Intervention Type DRUG

FF MDI 9.6 μg

Blinded Treatment

Intervention Type DRUG

BD MDI 320 μg

Blinded Treatment

Intervention Type DRUG

Symbicort® TBH 400/12 μg BID

Open Label

Intervention Type DRUG

Other Intervention Names

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Budesonide and Formoterol Fumarate Inhalation Aerosol Budesonide and Formoterol Fumarate Inhalation Aerosol Formoterol Fumarate Inhalation Aerosol Budesonide Inhalation Aerosol Symbicort® Turbuhaler

Eligibility Criteria

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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).
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pearl Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Athens, Alabama, United States

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Birmingham, Alabama, United States

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Dothan, Alabama, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Gold River, California, United States

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Palm Springs, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Boulder, Colorado, United States

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Colorado Springs, Colorado, United States

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Littleton, Colorado, United States

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Hamden, Connecticut, United States

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Clearwater, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Panama City, Florida, United States

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Port Orange, Florida, United States

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Port Orange, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Blue Ridge, Georgia, United States

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Meridian, Idaho, United States

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Towson, Maryland, United States

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Westminster, Maryland, United States

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North Dartmouth, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Edina, Minnesota, United States

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Fridley, Minnesota, United States

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Minneapolis, Minnesota, United States

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Woodbury, Minnesota, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Henderson, Nevada, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Jackson Heights, New York, United States

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Larchmont, New York, United States

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Charlotte, North Carolina, United States

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Gastonia, North Carolina, United States

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Greensboro, North Carolina, United States

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Huntersville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Dublin, Ohio, United States

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Grove City, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Anderson, South Carolina, United States

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Easley, South Carolina, United States

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Gaffney, South Carolina, United States

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Greenville, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Old Point Station, South Carolina, United States

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Rock Hill, South Carolina, United States

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Seneca, South Carolina, United States

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Spartanburg, South Carolina, United States

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Union, South Carolina, United States

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Johnson City, Tennessee, United States

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Kingsport, Tennessee, United States

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Channelview, Texas, United States

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Live Oak, Texas, United States

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New Braunfels, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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South Burlington, Vermont, United States

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Newport News, Virginia, United States

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Richmond, Virginia, United States

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Bellevue, Washington, United States

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Bellevue, Washington, United States

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Tacoma, Washington, United States

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Edmonton, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Truro, Nova Scotia, Canada

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Ajax, Ontario, Canada

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Burlington, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Windsor, Ontario, Canada

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Mirabel, Quebec, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Quebec, Canada

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Saint-Charles-Borromée, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Victoriaville, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Québec, , Canada

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Boskovice, , Czechia

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Brandýs nad Labem, , Czechia

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Jindřichův Hradec, , Czechia

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Liberec, , Czechia

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Lovosice, , Czechia

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Nový Bor, , Czechia

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Ostrava-Hrabuvka, , Czechia

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Ostrava-Poruba, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Rokycany, , Czechia

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Strakonice, , Czechia

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Teplice, , Czechia

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Varnsdorf, , Czechia

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Žatec, , Czechia

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Bamberg, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Cologne, , Germany

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Darmstadt, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Leipzig, , Germany

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Leipzig, , Germany

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Lübeck, , Germany

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Rodgau-Dudenhofen, , Germany

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Schwerin, , Germany

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Balassagyarmat, , Hungary

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Budapest, , Hungary

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Cegléd, , Hungary

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Csorna, , Hungary

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Gödöllő, , Hungary

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Hajdúnánás, , Hungary

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Hatvan, , Hungary

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Komárom, , Hungary

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Makó, , Hungary

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Miskolc, , Hungary

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Nyíregyháza, , Hungary

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Pécs, , Hungary

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Pécs, , Hungary

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Siófok, , Hungary

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Százhalombatta, , Hungary

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Szeged, , Hungary

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Szolnok, , Hungary

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Bialystok, , Poland

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Bialystok, , Poland

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Bialystok, , Poland

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Bielsko-Biala, , Poland

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Chełm, , Poland

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Elblag, , Poland

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Gdansk, , Poland

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Grudziądz, , Poland

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Katowice, , Poland

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Kościan, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Legnica, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Nowy Duninów, , Poland

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Ostrowiec Świętokrzyski, , Poland

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Ostrów Wielkopolski, , Poland

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Piekary Śląskie, , Poland

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Piła, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Proszowice, , Poland

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Puławy, , Poland

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Ruda Śląska, , Poland

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Rzeszów, , Poland

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Rzeszów, , Poland

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Siedlce, , Poland

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Sochaczew, , Poland

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Suwałki, , Poland

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Szczecin, , Poland

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Tarnów, , Poland

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Trzebnica, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wieluń, , Poland

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Wołomin, , Poland

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Wroclaw, , Poland

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Zabrze, , Poland

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Zamość, , Poland

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Barnaul, , Russia

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Chelyabinsk, , Russia

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Ivanovo, , Russia

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Izhevsk, , Russia

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Kazan', , Russia

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Kazan', , Russia

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Kirov, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Novosibirsk, , Russia

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Novosibirsk, , Russia

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Novosibirsk, , Russia

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Novosibirsk, , Russia

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Omsk, , Russia

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Omsk, , Russia

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Penza, , Russia

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Penza, , Russia

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Perm, , Russia

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Pytigorsk, , Russia

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Rostov-on-Don, , Russia

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Ryazan, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Smolensk, , Russia

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Smolensk, , Russia

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Ulyanovsk, , Russia

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Vladimir, , Russia

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Voronezh, , Russia

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Yaroslavl, , Russia

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Yaroslavl, , Russia

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Yekaterinburg, , Russia

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Yekaterinburg, , Russia

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Anyang-si, , South Korea

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Busan, , South Korea

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Incheon, , South Korea

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Jeonju, , South Korea

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Seongnam-si, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Countries

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United States Canada Czechia Germany Hungary Poland Russia South Korea

References

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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.

Reference Type DERIVED
PMID: 35815359 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30220648 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4181&filename=PT009002_TELOS_PROTOCOL_REDACTED_07AUG2018_PDFA.pdf

Related Info

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4181&filename=d7820c00001-12-1-09-Final_sap_PDFA.pdf

Related Info

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4181&filename=PT009002_TELOS_PROTOCOL_REDACTED_PDFA.pdf

Related Info

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4181&filename=PT009002_Final_sap_Redacted_PDFA.pdf

Related Info

Other Identifiers

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PT009002

Identifier Type: -

Identifier Source: org_study_id

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