A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos) (KRONOS)

A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® as an Active Control in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Drug: BGF MDI 320/14.4/9.6 μg; Drug: GFF MDI (PT003) 14.4/9.6 μg; Drug: BFF MDI (PT009) 320/9.6 μg; Drug: Symbicort® Turbuhaler® (TBH) Inhalation Powder

Detailed Description

A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® as an Active Control in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

This study includes the following 3 sub-studies: 12-hour Pulmonary Function Test (PFT), Pharmacokinetic (PK) Profile, and Hypothalamic-pituitary-adrenal Axis.

• Study Type: Interventional
• Enrollment (Actual): 1902
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Research Site
  • Quebec, Canada, G1W 4R4
    • Research Site
  • Nova Scotia
    • Truro, Nova Scotia, Canada, B2N 1L2
      • Research Site
  • Ontario
    • Mississauga, Ontario, Canada, L4V 1P1
      • Research Site
    • Sudbury, Ontario, Canada, P3A 1W8
      • Research Site
    • Toronto, Ontario, Canada, M3J 2C5
      • Research Site
  • Quebec
    • Mirabel, Quebec, Canada, J7J 2K8
      • Research Site
    • Montreal, Quebec, Canada, H1M 1B1
      • Research Site
    • Trois-Rivières, Quebec, Canada, G8T 7A1
      • Research Site
• China
  • Anqing, China, 246003
    • Research Site
  • Baotou, China, 14010
    • Research Site
  • Beijing, China, 100730
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  • Beijing, China, 100853
    • Research Site
  • Beijing, China, 100048
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  • Beijing, China, CN-100029
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  • Changchun, China, 130021
    • Research Site
  • Changsha, China, 410011
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  • Changsha, China, 410002
    • Research Site
  • Guangzhou, China, 510120
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  • Guangzhou, China, 510150
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  • Guangzhou, China, 510000
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  • Guangzhou, China, 510180
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  • Haikou, China, 570311
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  • Hangzhou, China, 310014
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  • Hohhot, China, 010017
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  • Huhehaote, China, 010050
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  • Jinan, China, 250013
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  • Lianyungang, China, 222 002
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  • Linhai, China, 317000
    • Research Site
  • Nanchang, China, 330006
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  • Pingxiang, China, 337055
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  • Shanghai, China, 200433
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  • Shanghai, China, 200092
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  • Shanghai, China, 200120
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  • Shanghai, China, 200240
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  • Shengyang, China, 110004
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  • Shenyang, China, 110016
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  • Shenyang, China, 110001
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  • Taiyuan, China, 030001
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  • Tianjin, China, 300052
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  • Urumchi, China, 830054
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  • Wenzhou, China, 325027
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  • Wuhan, China, 430022
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  • Wuxi, China, 320204
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  • Xuzhou, China, 221006
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  • Yangzhou, China, 225012
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  • Yiyang Shi, China, 413000
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  • Zhuhai, China, 519099
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• Japan
  • Bunkyo-ku, Japan, 113-8431
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  • Chuo-ku, Japan, 103-0022
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  • Chuo-ku, Japan, 103-0027
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  • Chuo-ku, Japan, 104-8560
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  • Date-gun, Japan, 969-1793
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  • Fukuoka-shi, Japan, 814-0180
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  • Ginowan-shi, Japan, 901-2214
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  • Hakata-shi, Japan, 812-0033
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  • Hamamatsu-shi, Japan, 430-0906
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  • Hamamatsu-shi, Japan, 430-8525
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  • Hamamatsu-shi, Japan, 434-8511
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  • Higashiokitama-gun, Japan, 992-0601
    • Research Site
  • Higashiosaka-shi, Japan, 577-0843
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  • Himeji-shi, Japan, 672-8064
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  • Hirakata-shi, Japan, 573-1191
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  • Iizuka-shi, Japan, 820-8505
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  • Itabashi-ku, Japan, 173-8610
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  • Iwata-shi, Japan, 438-8550
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  • Izumo-shi, Japan, 693-8501
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  • Izumo-shi, Japan, 693-0068
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  • Kagoshima-shi, Japan, 892-0847
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  • Kahoku-gun, Japan, 920-0293
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  • Kakogawa-shi, Japan, 675-0023
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  • Kasaoka-shi, Japan, 714-0081
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  • Kasuga-shi, Japan, 816-0813
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  • Kishiwada-shi, Japan, 596-8501
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  • Kiyose-shi, Japan, 204-0023
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  • Kobe-shi, Japan, 650-0017
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  • Koga-shi, Japan, 811-3195
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  • Kurashiki-shi, Japan, 711-0921
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  • Kure-shi, Japan, 737-0193
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  • Kure-shi, Japan, 737-8505
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  • Kyoto-shi, Japan, 607-8062
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  • Kyoto-shi, Japan, 601-1434
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  • Kyoto-shi, Japan, 601-8206
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  • Kyoto-shi, Japan, 602-8026
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  • Kyoto-shi, Japan, 615-8087
    • Research Site
  • Maebashi-shi, Japan, 371-0054
    • Research Site
  • Matsumoto-shi, Japan, 390-0872
    • Research Site
  • Matsusaka-shi, Japan, 515-8544
    • Research Site
  • Meguro-ku, Japan, 153-8515
    • Research Site
  • Mitaka-shi, Japan, 181-8611
    • Research Site
  • Mizunami-shi, Japan, 509-6134
    • Research Site
  • Nagaoka-shi, Japan, 940-2085
    • Research Site
  • Nagoya-shi, Japan, 466-8560
    • Research Site
  • Nagoya-shi, Japan, 454-8502
    • Research Site
  • Nagoya-shi, Japan, 457-8511
    • Research Site
  • Naha-shi, Japan, 902-0061
    • Research Site
  • Nishishirakawa-gun, Japan, 969-0213
    • Research Site
  • Obihiro-shi, Japan, 080-0013
    • Research Site
  • Ogaki-shi, Japan, 503-8502
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  • Oita-shi, Japan, 870-0921
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  • Oita-shi, Japan, 870-0951
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  • Okinawa-shi, Japan, 904-2143
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  • Ookawa-shi, Japan, 831-0016
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  • Osaka-shi, Japan, 543-0035
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  • Osakasayama-shi, Japan, 589-8511
    • Research Site
  • Otsu-shi, Japan, 520-0804
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  • Sakai-shi, Japan, 591-8555
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  • Sakaide-shi, Japan, 762-8550
    • Research Site
  • Sapporo-shi, Japan, 001-0901
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  • Sapporo-shi, Japan, 064-0915
    • Research Site
  • Sendai-shi, Japan, 980-8574
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  • Sendai-shi, Japan, 983-0824
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  • Sendai-shi, Japan, 984-8560
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  • Seto-shi, Japan, 489-8642
    • Research Site
  • Shinagawa-ku, Japan, 142-8666
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  • Shinjuku-ku, Japan, 162-0052
    • Research Site
  • Shizuoka-shi, Japan, 420-8630
    • Research Site
  • Suita-shi, Japan, 564-0013
    • Research Site
  • Tachikawa-shi, Japan, 190-0014
    • Research Site
  • Takamatsu-shi, Japan, 760-8538
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  • Toon-shi, Japan, 791-0281
    • Research Site
  • Toshima-ku, Japan, 171-0014
    • Research Site
  • Toyama-shi, Japan, 930-0194
    • Research Site
  • Toyama-shi, Japan, 931-8533
    • Research Site
  • Toyama-shi, Japan, 939-8282
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  • Yanagawa-shi, Japan, 832-0059
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  • Yokohama-shi, Japan, 236-0004
    • Research Site
• United States
  • Alabama
    • Andalusia, Alabama, United States, 36420
      • Research Site
    • Jasper, Alabama, United States, 35501
      • Research Site
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Research Site
    • Phoenix, Arizona, United States, 85018
      • Research Site
  • California
    • Fullerton, California, United States, 92835
      • Research Site
    • Gold River, California, United States, 95670
      • Research Site
    • Poway, California, United States, 92064
      • Research Site
    • Rolling Hills Estates, California, United States, 90274
      • Research Site
    • Sacramento, California, United States, 95821
      • Research Site
  • Florida
    • Clearwater, Florida, United States, 33756
      • Research Site
    • Miami, Florida, United States, 33186
      • Research Site
    • Miami, Florida, United States, 33175
      • Research Site
    • Ormond Beach, Florida, United States, 32174
      • 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
      • Research Site
  • Georgia
    • Dacula, Georgia, United States, 30019
      • Research Site
    • Norcross, Georgia, United States, 30071
      • Research Site
    • Rincon, Georgia, United States, 31326
      • Research Site
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Research Site
    • Minneapolis, Minnesota, United States, 55402
      • Research Site
    • Minneapolis, Minnesota, United States, 55407
      • Research Site
    • Woodbury, Minnesota, United States, 55125
      • Research Site
  • Missouri
    • Saint Charles, Missouri, United States, 63301
      • Research Site
    • Saint Louis, Missouri, United States, 63141
      • Research Site
  • Nevada
    • Reno, Nevada, United States, 89503
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Research Site
    • Gastonia, North Carolina, United States, 28054
      • Research Site
    • Greensboro, North Carolina, United States, 27408
      • Research Site
    • Hendersonville, North Carolina, United States, 28739
      • Research Site
    • Mooresville, North Carolina, United States, 28117
      • Research Site
    • Wilmington, North Carolina, United States, 28401
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Research Site
    • Cincinnati, Ohio, United States, 45242
      • Research Site
    • Cincinnati, Ohio, United States, 45245
      • Research Site
    • Columbus, Ohio, United States, 43235
      • Research Site
    • Columbus, Ohio, United States, 43213
      • Research Site
    • Dayton, Ohio, United States, 45459
      • Research Site
    • Dublin, Ohio, United States, 43016
      • Research Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • Research Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Research Site
    • Charleston, South Carolina, United States, 29406
      • Research Site
    • Easley, South Carolina, United States, 29640
      • Research Site
    • Greenville, South Carolina, United States, 29615
      • Research Site
    • Indian Land, South Carolina, United States, 29707
      • Research Site
    • Mount Pleasant, South Carolina, United States, 29464
      • Research Site
    • Rock Hill, South Carolina, United States, 29732
      • Research Site
    • Seneca, South Carolina, United States, 29678
      • Research Site
    • Spartanburg, South Carolina, United States, 29303
      • Research Site
    • Union, South Carolina, United States, 29379
      • Research Site
  • Tennessee
    • Johnson City, Tennessee, United States, 37601
      • Research Site
  • Texas
    • Kingwood, Texas, United States, 77339
      • Research Site
    • Longview, Texas, United States, 75605
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site
  • Virginia
    • Abingdon, Virginia, United States, 24210
      • Research Site
    • Newport News, Virginia, United States, 23606
      • Research Site
    • Richmond, Virginia, United States, 23225
      • Research Site
    • Richmond, Virginia, United States, 23229
      • Research Site
  • Washington
    • Tacoma, Washington, United States, 98405
      • Research Site
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Given their signed written informed consent to participate.
• 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), or other local applicable guidelines.
• Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
• Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <80% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).
• Required COPD maintenance therapy:
• All Subjects must have been on two or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening. Scheduled SABA and/or scheduled SAMA are considered inhaled maintenance therapies

Please refer to the study protocol for the complete inclusion criteria list.

Exclusion Criteria

• Significant diseases or conditions other than COPD, 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 are planning to become pregnant during the course of the study, 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
• 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
• Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia.
• Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated.
• Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs.

Please refer to the study protocol for the complete inclusion criteria list.

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: BGF MDI (PT010) 320/14.4/9.6 μg ex-actuator; BGF MDI 320/14.4/9.6 μg,Budesonide, Glycopyrronium, Formoterol Fumarate Inhalation Aerosol	Drug: BGF MDI 320/14.4/9.6 μg; Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI]); Other Names: BGF
Experimental: GFF MDI (PT003) 14.4/9.6 μg ex-actuator; GFF MDI 14.4/9.6 μg ex-actuator Glycopyrronium, Formoterol Fumarate Inhalation Aerosol	Drug: GFF MDI (PT003) 14.4/9.6 μg; Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI); Other Names: GFF
Experimental: BFF MDI (PT009) 320/9.6 μg ex-actuator; BFF MDI 320/9.6 μg, Budesonide, Formoterol Fumarate Inhalation Aerosol	Drug: BFF MDI (PT009) 320/9.6 μg; Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI); Other Names: BFF
Active Comparator: Symbicort; Symbicort® Turbuhaler® (TBH) Inhalation Powder 200/6 μg	Drug: Symbicort® Turbuhaler® (TBH) Inhalation Powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1 AUC0-4	FEV1 AUC0-4 (L) for The Efficacy Estimand (Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4) AUC was normalized for length of follow up (e.g. typically 4 hours)).	at Week 24
Change From Baseline in Morning Pre-dose Trough FEV1	Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand	at Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Morning Pre-dose Trough FEV1	Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand	over 24 Weeks
Peak Change From Baseline in FEV1 Within 4 Hours Post-dosing	Peak Change from Baseline in FEV1 (L) Within 4 Hours Post-Dose for The Efficacy Estimand	at Week 24
Rate of Moderate or Severe COPD Exacerbations	Rate of Moderate or Severe COPD Exacerbations for the Efficacy Estimand	over 24 weeks
Percentage of Subjects Achieving a Minimal Clinically Important Difference (MCID) of 4 Units or More in SGRQ Total Score (SGRQ Responders)	Change from BGF	at Week 24
Change From Baseline in Average Daily Rescue Ventolin HFA Use	Change from Baseline in Mean Daily Number of Puffs of Rescue Ventolin HFA for The Efficacy Estimand	over 24 Weeks
Time to Onset of Action on Day 1, 5 Minutes Post Dose	FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand	Day 1
Time to Onset of Action on Day 1, 15 Minutes Post Dose	FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand	Day 1
Time to Onset of Action on Day 1, 30 Minutes Post Dose	FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand	Day 1
Time to Onset of Action on Day 1, 1 Hour Post Dose	FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand	Day 1
Time to Onset of Action on Day 1, 2 Hours Post Dose	FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand	Day 1
Time to Onset of Action on Day 1, 4 Hours Post Dose	FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand	Day 1

Collaborators and Investigators

• Sponsor: Pearl Therapeutics, Inc.
• Investigators: Study Director: Paul Dorinsky, MD, 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.
• Huang Y, Assam PN, Feng C, Su R, Dorinsky P, Gillen M. Ethnic pharmacokinetic comparison of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) between Asian and Western healthy subjects. Pulm Pharmacol Ther. 2020 Oct;64:101976. doi: 10.1016/j.pupt.2020.101976. Epub 2020 Nov 2.
• Dunn LJ, Kerwin EM, DeAngelis K, Darken P, Gillen M, Dorinsky P. Pharmacokinetics of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler formulated using co-suspension delivery technology after single and chronic dosing in patients with COPD. Pulm Pharmacol Ther. 2020 Feb;60:101873. doi: 10.1016/j.pupt.2019.101873. Epub 2019 Dec 10.
• Liu J, He X, Wu J. Economic Evaluation of Triple Therapy with Budesonide/Glycopyrrolate/Formoterol Fumarate for the Treatment of Moderate to Very Severe Chronic Obstructive Pulmonary Disease in China Using a Semi-Markov Model. Appl Health Econ Health Policy. 2022 Sep;20(5):743-755. doi: 10.1007/s40258-022-00732-1. Epub 2022 Apr 28.
• Muro S, Sugiura H, Darken P, Dorinsky P. Efficacy of budesonide/glycopyrronium/formoterol metered dose inhaler in patients with COPD: post-hoc analysis from the KRONOS study excluding patients with airway reversibility and high eosinophil counts. Respir Res. 2021 Jun 28;22(1):187. doi: 10.1186/s12931-021-01773-1. Erratum In: Respir Res. 2021 Aug 9;22(1):223.
• Wang C, Yang T, Kang J, Chen R, Zhao L, He H, Assam PN, Su R, Bourne E, Ballal S, DeAngelis K, Dorinsky P. Efficacy and Safety of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler in Chinese Patients with COPD: A Subgroup Analysis of KRONOS. Adv Ther. 2020 Apr;37(4):1591-1607. doi: 10.1007/s12325-020-01266-5. Epub 2020 Mar 6.
• Ichinose M, Fukushima Y, Inoue Y, Hataji O, Ferguson GT, Rabe KF, Hayashi N, Okada H, Takikawa M, Bourne E, Ballal S, DeAngelis K, Aurivillius M, Reisner C, Dorinsky P. Long-Term Safety and Efficacy of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Japanese Patients with COPD. Int J Chron Obstruct Pulmon Dis. 2019 Dec 23;14:2993-3002. doi: 10.2147/COPD.S220861. eCollection 2019.
• Ferguson GT, Rabe KF, Martinez FJ, Fabbri LM, Wang C, Ichinose M, Bourne E, Ballal S, Darken P, DeAngelis K, Aurivillius M, Dorinsky P, Reisner C. Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, phase 3 randomised controlled trial. Lancet Respir Med. 2018 Oct;6(10):747-758. doi: 10.1016/S2213-2600(18)30327-8. Epub 2018 Sep 16. Erratum In: Lancet Respir Med. 2018 Oct 4;: Lancet Respir Med. 2019 Feb;7(2):e9.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2015
• Primary Completion (Actual): January 5, 2018
• Study Completion (Actual): January 5, 2018

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Asthmatic Agents; Respiratory System Agents; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: PT010006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

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