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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: GFF MDI (PT003); Drug: FF MDI (PT005); Drug: GP MDI (PT001); Drug: Placebo MDI

Detailed Description

A randomized, double-blind, chronic dosing (24 weeks), placebo-controlled, parallel group, multi-center study to assess the efficacy and safety of glycopyrronium and formoterol fumarate inhalation aerosol (GFF; PT003), formoterol fumarate inhalation aerosol (FF; PT005), and glycopyrronium inhalation aerosol (GP; PT001) in subjects with moderate to very severe COPD, compared with placebo.

• Study Type: Interventional
• Enrollment (Actual): 1756
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100050
    • Research Site
  • Beijing, China, 100029
    • Research Site
  • Beijing, China, 100144
    • Research Site
  • Changchun, China, 130021
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  • Changsha, China, 410011
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  • Chengdu, China, 610083
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  • Chengdu, China, CN-610041
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  • Guangzhou, China, 510120
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  • Guangzhou, China, 510000
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  • Guangzhou, China, 510515
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  • Guiyang, China, 510630
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  • Haikou, China, 570311
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  • Hefei, China, 230001
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  • Hohhot, China, 010017
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  • Nanchang, China, 330006
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  • Nanjing, China, 210009
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  • Nanning, China, 530021
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  • Shanghai, China, 200433
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  • Shanghai, China, 200040
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  • Shanghai, China, 200120
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  • Shengyang, China, 110004
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  • Shenyang, China, 110016
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  • Shijiazhuang, China, 050000
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  • Shijiazhuang, China, 050051
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  • Soochow City, China, 215006
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  • Taiyuan, China, 030001
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  • Tianjin, China, 300052
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  • Wuxi, China, 214023
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  • Xiamen, China, 361004
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  • Xining, China, 810007
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  • Yiyang Shi, China, 413000
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• Czechia
  • Jindrichuv Hradec, Czechia, 37701
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  • Ostrava-Hrabuvka, Czechia, 700 30
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  • Praha, Czechia, 15000
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  • Teplice, Czechia, 415 01
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• Germany
  • Augsburg, Germany, 86150
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  • Berlin, Germany, 10629
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  • Berlin, Germany, 10787
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  • Berlin, Germany, 12157
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  • Grosshansdof, Germany, 22927
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  • Hamburg, Germany, 20354
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  • Leipzig, Germany, 04357
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  • Leipzig, Germany, 04103
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  • Lübeck, Germany, 23552
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  • Wiesbaden, Germany, 65187
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• Hungary
  • Budapest, Hungary, 1135
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  • Gödöllő, Hungary, 2100
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  • Nyíregyháza, Hungary, 4400
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  • Pécs, Hungary, 7635
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  • Siófok, Hungary, 8600
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  • Szeged, Hungary, H-6722
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• Japan
  • Ako-shi, Japan, 678-0239
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  • Asahikawa-shi, Japan, 070-8644
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  • Chuo-ku, Japan, 103-0028
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  • Chuo-ku, Japan, 103-0027
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  • Fukuoka-shi, Japan, 811-1394
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  • Hamamatsu-shi, Japan, 434-8511
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  • Himeji-shi, Japan, 672-8064
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  • Himeji-shi, Japan, 671-0102
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  • Hitachinaka-shi, Japan, 312-0057
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  • Itabashi-ku, Japan, 173-8610
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  • Kakogawa-shi, Japan, 675-0023
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  • Kamogawa-shi, Japan, 296-0041
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  • Kanazawa-shi, Japan, 920-8201
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  • Kishiwada-shi, Japan, 596-8501
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  • Kobe-shi, Japan, 650-0047
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  • Koga-shi, Japan, 811-3195
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  • Matsumoto-shi, Japan, 390-8621
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  • Matsumoto-shi, Japan, 390-0872
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  • Mito-shi, Japan, 310-0015
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  • Nagaoka-shi, Japan, 940-2085
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  • Nagoya-shi, Japan, 457-0866
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  • Naka-gun, Japan, 319-1113
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  • Ohota-ku, Japan, 145-0063
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  • Oita-shi, Japan, 870-0951
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  • Saiki-shi, Japan, 876-0813
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  • Sendai-shi, Japan, 983-0824
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  • Sendai-shi, Japan, 981-8563
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  • Seto-shi, Japan, 489-8642
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  • Shimotsuga-gun, Japan, 321-0293
    • Research Site
  • Takamatsu-shi, Japan, 760-8538
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  • Toon-shi, Japan, 791-0281
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  • Yanagawa-shi, Japan, 832-0059
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  • Yokohama-shi, Japan, 232-0066
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  • Yokohama-shi, Japan, 241-0811
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• Korea, Republic of
  • Busan, Korea, Republic of, 602-715
    • Research Site
  • Daegu, Korea, Republic of, 42415
    • Research Site
  • Seoul, Korea, Republic of, 04551
    • Research Site
  • Seoul, Korea, Republic of, 152-703
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  • Seoul, Korea, Republic of, 130-872
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  • Seoul, Korea, Republic of, 136-705
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  • Seoul, Korea, Republic of, 130-709
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  • Wonju-si, Korea, Republic of, 220-701
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• Poland
  • Białystok, Poland, 15-003
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  • Białystok, Poland, 15-044
    • Research Site
  • Elbląg, Poland, 82-300
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  • Inowrocław, Poland, 88-100
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  • Lodz, Poland, 90-153
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  • Piekary Śląskie, Poland, 41-94O
    • Research Site
  • Rzeszów, Poland, 35-205
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  • Skierniewice, Poland, 96-100
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  • Szczecin, Poland, 70-111
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  • Tarnów, Poland, 33-100
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  • Torun, Poland, 87-100
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  • Warszawa Targowek, Poland, 03-291
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  • Łódź, Poland, 90-203
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• Russian Federation
  • Gatchina, Russian Federation, 188300
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  • Moscow, Russian Federation, 105229
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  • Moscow, Russian Federation, 127018
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  • Pytigorsk, Russian Federation, 357538
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  • Saint Petersburg, Russian Federation, 198260
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  • Saint-Petersburg, Russian Federation, 197022
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  • Saint-Petersburg, Russian Federation, 195271
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  • St. Petersburg, Russian Federation, 197022
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• Taiwan
  • Kaohsiung City, Taiwan, 83301
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  • Taichung, Taiwan, 40705
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  • Taichung, Taiwan, 40447
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  • Taipei, Taiwan, 10002
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• United Kingdom
  • Dundee, United Kingdom, DD1 9SY
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  • London, United Kingdom, EC1M 6BQ
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  • London, United Kingdom, W1G 8HU
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  • Northwood, United Kingdom, HA6 2RN
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  • Sidcup, United Kingdom, DA14 6LT
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• United States
  • Alabama
    • Andalusia, Alabama, United States, 36420
      • Research Site
    • Birmingham, Alabama, United States, 35209
      • Research Site
    • Foley, Alabama, United States, 36535
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    • Jasper, Alabama, United States, 35501
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  • California
    • Anaheim, California, United States, 92801
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  • Colorado
    • Boulder, Colorado, United States, 80301
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  • Florida
    • Clearwater, Florida, United States, 33765
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    • Clearwater, Florida, United States, 33756
      • Research Site
    • Kissimmee, Florida, United States, 34744
      • Research Site
    • Miami, Florida, United States, 33186
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    • Miami, Florida, United States, 33175
      • Research Site
    • Panama City, Florida, United States, 32405
      • Research Site
    • Pensacola, Florida, United States, 32503
      • Research Site
    • Tamarac, Florida, United States, 33321
      • Research Site
    • Tampa, Florida, United States, 33603
      • Research Site
    • Winter Park, Florida, United States, 32789-4681
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Research Site
    • Blue Ridge, Georgia, United States, 30513
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  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
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  • Minnesota
    • Edina, Minnesota, United States, 55435
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    • Fridley, Minnesota, United States, 55432
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    • Minneapolis, Minnesota, United States, 55407
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    • Woodbury, Minnesota, United States, 55125
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  • Missouri
    • Saint Charles, Missouri, United States, 63301
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    • Saint Louis, Missouri, United States, 63141
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  • North Carolina
    • Gastonia, North Carolina, United States, 28054
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
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  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Research Site
    • Columbus, Ohio, United States, 43215
      • Research Site
    • Columbus, Ohio, United States, 43231
      • Research Site
    • Dayton, Ohio, United States, 45459
      • Research Site
    • Dayton, Ohio, United States, 45419
      • Research Site
    • Dublin, Ohio, United States, 43016
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Research Site
  • Oregon
    • Medford, Oregon, United States, 97504
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  • South Carolina
    • Easley, South Carolina, United States, 29640
      • Research Site
    • Gaffney, South Carolina, United States, 29341
      • Research Site
    • Greenville, South Carolina, United States, 29615
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    • Rock Hill, South Carolina, United States, 29732
      • Research Site
    • Seneca, South Carolina, United States, 29678
      • Research Site
    • Spartanburg, South Carolina, United States, 29303
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    • Union, South Carolina, United States, 29379
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  • Tennessee
    • Johnson City, Tennessee, United States, 37601
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  • Virginia
    • Abingdon, Virginia, United States, 24210
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GFF MDI (PT003); Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)	Drug: GFF MDI (PT003); Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID); Other Names: Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol
Experimental: FF MDI (PT005); Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)	Drug: FF MDI (PT005); Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID); Other Names: Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol
Experimental: GP MDI (PT001); Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)	Drug: GP MDI (PT001); Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID); Other Names: Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol
Placebo Comparator: Placebo MDI; Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)	Drug: Placebo MDI; Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID); Other Names: Placebo (matching) for GFF MDI, FF MDI, and GP MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
TDI Focal Score Over 24 Weeks, US/China and EU/SK/TW Approach	TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9	over 24 Weeks
TDI Focal Score Over Weeks 12-24 Japan Approach	TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9	over Weeks 12-24
TDI Focal Score Over 24 Weeks - US/China and EU/SK/TW Approaches -Symptomatic Population	TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9	over 24 Weeks
TDI Focal Score Over Weeks 12-24 - Japan Approach - Symptomatic Population	TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9	over weeks 12-24
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing at Week 24 US/China Approach	Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24 US/China approach	at week 24
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over Weeks 12-24 Japan Approach	Peak change from baseline in FEV1 within 2 hours post-dosing over weeks 12-24 Japan approach	over weeks 12-24
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks EU/SK/TW Approach	Peak change from baseline in FEV1 within 2 hours post-dosing over 24 weeks EU/SK/TW approach	over 24 weeks
Change From Baseline in SGRQ Total Score at Week 24, US/China Approach	Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life	at week 24
Change From Baseline in SGRQ Total Score Over Weeks 12-24 , Japan & EU/SK/TW Approach	Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life	over weeks 12-24
Change From Baseline in SGRQ Total Score at Week 24 in Symptomatic Population, US/China Approach	Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life	at week 24
Change From Baseline in SGRQ Total Score Over Weeks 12-24, in Symptomatic Population, Japan & EU/SK/TW Approach	Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life	over weeks 12-24
Change From Baseline in Average Daily Rescue Ventolin Use Over 24 Weeks in RVU Population, All Approaches	Change from baseline in average daily rescue Ventolin use over 24 weeks in RVU population, all approaches	over 24 weeks
FEV1 Measured at 5 Minutes Post-dose on Day 1	Onset of Action as Assessed by FEV1 Day 1 at 5 Minutes Post-Dose. Reported is the FEV1 measured at 5 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant	Assessed at 5-minutes post dose on Day 1
FEV1 Measured at 15 Minutes Post-dose on Day 1	Onset of Action as Assessed by FEV1 Day 1 at 15 Minutes Post-Dose. Reported is the FEV1 measured at 15 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant	Assessed at 15-minute post dose on Day 1

Collaborators and Investigators

• Sponsor: Pearl Therapeutics, Inc.

Publications and helpful links

General Publications

• Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
• Martinez 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.
• Martinez 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.
• Chen 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.

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2015
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: January 6, 2015
• First Submitted That Met QC Criteria: January 15, 2015
• First Posted (Estimate): January 22, 2015

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Glycopyrrolate; Formoterol Fumarate
• Other Study ID Numbers: PT003014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No