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Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02465567
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE May 29, 2015
First Posted Date  ICMJE June 8, 2015
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE June 30, 2015
Actual Primary Completion Date July 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
Rate of moderate or severe COPD exacerbations [ Time Frame: (52-week treatment period) ]
Rate of moderate or severe COPD exacerbations
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2015)
effects of BGF MDI relative to GFF MDI and BFF MDI on lung function assessed by pulmonary function tests [ Time Frame: (52-week treatment period) ]
(Pulomonary Function Tests will be conducted over 4 hours in a subset of approximately 3,060 subjects (765 subjects per treatment group) at selected visits)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Time to first moderate or severe COPD exacerbation [ Time Frame: 52 Weeks ]
    Time to first moderate or severe COPD exacerbation
  • Change from baseline in average daily rescue Ventolin HFA use over 24 weeks [ Time Frame: 24 Weeks ]
    Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
  • Percentage of subjects achieving a MCID of 4 units or more in SGRQ total score at Week 24 [ Time Frame: 24 Weeks ]
    Percentage of subjects achieving a minimal clinically important difference (MCID) of 4 units or more in SGRQ (St. George's Respiratory Questionnaire) total score at Week 24
  • Time to death (all cause) [ Time Frame: 52 Weeks ]
    Time to death (all cause)
  • Rate of severe COPD exacerbations [ Time Frame: 52 Weeks ]
    Rate of severe COPD exacerbations
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2015)
  • effect of BGF MDI relative to GFF MDI and BFF MDI on symptoms of COPD assessed by EXACT [ Time Frame: (52-week treatment period) ]
    COPD Assessment - Exacerbations of Chronic Pulmonary Disease Tool (EXACT)
  • effect of BGF MDI relative to GFF MDI and BFF MDI on quality of life [ Time Frame: (52-week treatment period) ]
    For Quality of Life, European Quality-of-Life-5 Dimension-5 Level Questionnaire
  • effect of BGF MDI relative to GFF MDI and BFF MDI on all cause mortality [ Time Frame: (52-week treatment period) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)
Official Title  ICMJE A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)
Brief Summary This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.
Detailed Description A randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations over a 52-week treatment period in subjects with moderate to very severe COPD.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COPD
Intervention  ICMJE
  • Drug: BGF MDI 320/14.4/9.6 μg
    Budensonide, Glycopyrronium, and Formoterol Fumarate
    Other Name: BGF
  • Drug: GFF MDI 14.4/9.6 μg
    Glycopyrronium, and Formoterol Fumarate
    Other Name: GFF
  • Drug: BGF MDI 160/14.4/9.6 μg
    Budensonide, Glycopyrronium, and Formoterol Fumarate
    Other Name: BGF
  • Drug: BFF MDI 320/9.6 μg
    Budensonide, and Formoterol Fumarate
    Other Name: BFF
Study Arms  ICMJE
  • Experimental: BGF (PT010) MDI 320/14.4/9.6 μg
    BGF MDI 320/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler [MDI])
    Intervention: Drug: BGF MDI 320/14.4/9.6 μg
  • Experimental: BGF (PT010) MDI 160/14.4/9.6 μg
    BGF MDI 160/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler [MDI])
    Intervention: Drug: BGF MDI 160/14.4/9.6 μg
  • Experimental: BFF (PT009) MDI 320/9.6 μg
    BFF MDI 320/9.6 μg Budesonide, Formoterol Fumarate Aerosol Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT009)
    Intervention: Drug: BFF MDI 320/9.6 μg
  • Experimental: GFF (PT003) MDI 14.4/9.6 μg
    GFF MDI 14.4/9.6 μg Glycopyrronium, Formoterol Fumarate Aerosol Budesonide and Formoterol Fumarate Inhalation Aerosol (PT003)
    Intervention: Drug: GFF MDI 14.4/9.6 μg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2020)
8588
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2015)
8000
Actual Study Completion Date  ICMJE July 26, 2019
Actual Primary Completion Date July 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <65% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).
  • Subjects with history of exacerbations.

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)
  • 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)
  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Canada,   Chile,   China,   Czechia,   France,   Germany,   Hungary,   Italy,   Japan,   Mexico,   Netherlands,   New Zealand,   Peru,   Poland,   Russian Federation,   Serbia,   South Africa,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Brazil,   Korea, Republic of
 
Administrative Information
NCT Number  ICMJE NCT02465567
Other Study ID Numbers  ICMJE PT010005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pearl Therapeutics, Inc.
Study Sponsor  ICMJE Pearl Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paul M Dorinsky, MD Pearl Therapeutics
PRS Account Pearl Therapeutics, Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP