Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD
A Randomized, Double-Blind, Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo
1 other identifier
interventional
1,756
11 countries
166
Brief Summary
A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease
Started Mar 2015
Typical duration for phase_3 chronic-obstructive-pulmonary-disease
166 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
January 6, 2015
CompletedFirst Posted
Study publicly available on registry
January 22, 2015
CompletedStudy Start
First participant enrolled
March 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2017
CompletedResults Posted
Study results publicly available
February 20, 2019
CompletedFebruary 20, 2019
January 1, 2019
2.4 years
January 6, 2015
July 11, 2018
January 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach)
For the US/China approach, the primary endpoint was the change from baseline in morning pre-dose trough FEV1 at Week 24 of treatment
at week 24
Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach
Change from baseline in morning pre-dose trough FEV1 over weeks 12-24, Japan approach
over weeks 12-24
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach.
Change from baseline in morning pre-dose trough FEV1 over 24 weeks. Primary endpoint, EU/SK/TW approach, Secondary endpoint US/China approach.
over 24 weeks
Secondary Outcomes (14)
TDI Focal Score Over 24 Weeks, US/China and EU/SK/TW Approach
over 24 Weeks
TDI Focal Score Over Weeks 12-24 Japan Approach
over Weeks 12-24
TDI Focal Score Over 24 Weeks - US/China and EU/SK/TW Approaches -Symptomatic Population
over 24 Weeks
TDI Focal Score Over Weeks 12-24 - Japan Approach - Symptomatic Population
over weeks 12-24
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing at Week 24 US/China Approach
at week 24
- +9 more secondary outcomes
Study Arms (4)
GFF MDI (PT003)
EXPERIMENTALGlycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
FF MDI (PT005)
EXPERIMENTALFormoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
GP MDI (PT001)
EXPERIMENTALGlycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Placebo MDI
PLACEBO COMPARATORPlacebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)
Interventions
Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)
Eligibility Criteria
You may qualify if:
- Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
- Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS).
- Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
- Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of \<0.70.
- FEV1 must be \<80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms applicable to other regions).
You may not qualify if:
- Significant diseases other than COPD, ie, disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
- Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception.
- Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
- Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
- Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
- Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.
- Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (166)
Research Site
Andalusia, Alabama, 36420, United States
Research Site
Birmingham, Alabama, 35209, United States
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Foley, Alabama, 36535, United States
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Jasper, Alabama, 35501, United States
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Anaheim, California, 92801, United States
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Boulder, Colorado, 80301, United States
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Clearwater, Florida, 33756, United States
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Clearwater, Florida, 33765, United States
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Kissimmee, Florida, 34744, 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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Pensacola, Florida, 32503, United States
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Tamarac, Florida, 33321, 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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Atlanta, Georgia, 30331, United States
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Blue Ridge, Georgia, 30513, United States
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North Dartmouth, Massachusetts, 02747, 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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Gastonia, North Carolina, 28054, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45242, United States
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Columbus, Ohio, 43215, United States
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Columbus, Ohio, 43231, United States
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Dayton, Ohio, 45419, United States
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Dayton, Ohio, 45459, United States
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Dublin, Ohio, 43016, 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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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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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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Abingdon, Virginia, 24210, United States
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Beijing, 100029, China
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Beijing, 100050, China
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Beijing, 100144, China
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Changchun, 130021, China
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Changsha, 410011, China
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Chengdu, 610083, China
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Chengdu, CN-610041, China
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Guangzhou, 510000, China
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Guangzhou, 510120, China
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Guangzhou, 510515, China
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Guiyang, 510630, China
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Haikou, 570311, China
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Hefei, 230001, China
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Heshan, 413000, China
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Hohhot, 010017, China
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Nanchang, 330006, China
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Nanjing, 210009, China
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Nanning, 530021, China
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Shanghai, 200040, China
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Shanghai, 200120, China
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Shanghai, 200433, China
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Shengyang, 110004, China
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Shenyang, 110016, China
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Shijiazhuang, 050000, China
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Shijiazhuang, 050051, China
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Suzhou, 215006, China
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Taiyuan, 030001, China
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Tianjin, 300052, China
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Wuxi, 214023, China
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Xiamen, 361004, China
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Xining, 810007, China
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Jindřichův Hradec, 37701, Czechia
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Ostrava-Hrabuvka, 700 30, Czechia
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Prague, 15000, Czechia
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Teplice, 415 01, Czechia
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Augsburg, 86150, 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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Grosshansdof, 22927, Germany
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Hamburg, 20354, Germany
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Leipzig, 04103, Germany
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Leipzig, 04357, Germany
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Lübeck, 23552, Germany
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Wiesbaden, 65187, Germany
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Budapest, 1135, Hungary
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Gödöllő, 2100, Hungary
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Nyíregyháza, 4400, Hungary
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Pécs, 7635, Hungary
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Siófok, 8600, Hungary
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Szeged, H-6722, Hungary
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Ako-shi, 678-0239, Japan
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Asahikawa-shi, 070-8644, Japan
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Chūōku, 103-0027, Japan
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Chūōku, 103-0028, Japan
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Fukuoka, 811-1394, Japan
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Hamamatsu, 434-8511, Japan
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Himeji-shi, 671-0102, Japan
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Himeji-shi, 672-8064, Japan
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Hitachi-Naka, 312-0057, Japan
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Itabashi-ku, 173-8610, Japan
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Kakogawa-shi, 675-0023, Japan
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Kamogawa-shi, 296-0041, Japan
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Kanazawa, 920-8201, Japan
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Kishiwada-shi, 596-8501, Japan
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Kobe, 650-0047, Japan
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Koga-shi, 811-3195, Japan
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Matsumoto-shi, 390-0872, Japan
Research Site
Matsumoto-shi, 390-8621, Japan
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Mito, 310-0015, Japan
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Nagaoka-shi, 940-2085, Japan
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Nagoya, 457-0866, Japan
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Naka-gun, 319-1113, Japan
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Ohota-ku, 145-0063, Japan
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Ōita, 870-0951, Japan
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Saiki-shi, 876-0813, Japan
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Sendai, 981-8563, Japan
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Sendai, 983-0824, Japan
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Seto-shi, 489-8642, Japan
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Shimotsuga-gun, 321-0293, Japan
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Takamatsu, 760-8538, Japan
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Toon-shi, 791-0281, Japan
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Yanagawa-shi, 832-0059, Japan
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Yokohama, 232-0066, Japan
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Yokohama, 241-0811, Japan
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Bialystok, 15-003, Poland
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Bialystok, 15-044, Poland
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Elblag, 82-300, Poland
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Inowrocław, 88-100, Poland
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Lodz, 90-153, Poland
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Lodz, 90-203, Poland
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Piekary Śląskie, 41-94O, Poland
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Rzeszów, 35-205, Poland
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Skierniewice, 96-100, Poland
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Szczecin, 70-111, Poland
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Tarnów, 33-100, Poland
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Torun, 87-100, Poland
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Warszawa Targowek, 03-291, Poland
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Gatchina, 188300, Russia
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Moscow, 105229, Russia
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Moscow, 127018, Russia
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Pytigorsk, 357538, Russia
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Saint Petersburg, 195271, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 198260, Russia
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Busan, 602-715, South Korea
Research Site
Daegu, 42415, South Korea
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Seoul, 04551, South Korea
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Seoul, 130-709, South Korea
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Seoul, 130-872, South Korea
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Seoul, 136-705, South Korea
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Seoul, 152-703, South Korea
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Wŏnju, 220-701, South Korea
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Kaohsiung City, 83301, Taiwan
Research Site
Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 10002, Taiwan
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Dundee, DD1 9SY, United Kingdom
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London, EC1M 6BQ, United Kingdom
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London, W1G 8HU, United Kingdom
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Northwood, HA6 2RN, United Kingdom
Research Site
Sidcup, DA14 6LT, United Kingdom
Related Publications (4)
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: 35815359DERIVEDMartinez FJ, Lipworth BJ, Rabe KF, Collier DJ, Ferguson GT, Sethi S, Feldman GJ, O'Brien G, Jenkins M, Reisner C. Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies. Respir Res. 2020 May 25;21(1):128. doi: 10.1186/s12931-020-01388-y.
PMID: 32450869DERIVEDMartinez FJ, Rabe KF, Lipworth BJ, Arora S, Jenkins M, Martin UJ, Reisner C. Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Improves Lung Function versus Monotherapies in GOLD Category A Patients with COPD: Pooled Data from the Phase III PINNACLE Studies. Int J Chron Obstruct Pulmon Dis. 2020 Jan 9;15:99-106. doi: 10.2147/COPD.S229794. eCollection 2020.
PMID: 32021148DERIVEDChen R, Zhong N, Wang HY, Zhao L, Mei X, Qin Z, Huang J, Assam PN, Maes A, Siddiqui S, Martin UJ, Reisner C. Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2020 Jan 8;15:43-56. doi: 10.2147/COPD.S223638. eCollection 2020.
PMID: 32021143DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pearl Therapeutics Inc.
- Organization
- Pearl Therapeutics Inc.
Study Officials
- STUDY CHAIR
Colin Reisner, MD
Pearl Therapeutics, Inc.
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
January 6, 2015
First Posted
January 22, 2015
Study Start
March 30, 2015
Primary Completion
August 31, 2017
Study Completion
August 31, 2017
Last Updated
February 20, 2019
Results First Posted
February 20, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will share
AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. The policy and additional information can be found on astrazenecaclinicaltrials.com.