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To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BGF 320/14.4/9.6 µg MDI
BFF 320/9.6 µg
Sponsored by
Pearl Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Signed Informed Consent
  • Subjects with an established clinical history of COPD
  • Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <80% predicted normal value
  • All subjects must have been on 2 or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening
  • Current or former smokers with a history of at least 10 pack-years of cigarette smoking
  • Women of Non-childbearing potential
  • Women of childbearing potential and sexually active agree to prevent pregnancy by using acceptable contraceptive methods consistently

Key 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
  • Current diagnosis of asthma
  • Uncontrolled sleep apnea
  • Other Serious Respiratory Disorders
  • Hospitalized due to poorly controlled COPD within 6 weeks
  • Poorly Controlled COPD
  • Immune deficiency and/or severe neurological disorders affecting control of the upper airway
  • Hypersensitivity to β2-agonists, corticosteroids, or muscarinic anticholinergics

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    BGF 320/14.4/9.6 µg MDI BID

    BFF 320/9.6 µg MDI BID

    Arm Description

    Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)

    Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)

    Outcomes

    Primary Outcome Measures

    Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4)

    Secondary Outcome Measures

    Change from baseline in morning pre-dose trough FEV1
    Peak change from baseline in inspiratory capacity
    Percentage of subjects achieving a minimally clinical important difference (MCID) of 4 units or more in St. George's Respiratory Questionnaire (SGRQ)
    Time to first clinically important deterioration (CID) in COPD
    Change from baseline in average daily rescue Ventolin HFA use
    Peak change from baseline in FEV1
    Time to onset of action

    Full Information

    First Posted
    March 6, 2017
    Last Updated
    July 31, 2018
    Sponsor
    Pearl Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03081247
    Brief Title
    To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
    Official Title
    A Randomized, Double-Blind, Parallel-Group, 12-Week, Chronic Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Internal Study team decision not to proceed.
    Study Start Date
    April 16, 2018 (Anticipated)
    Primary Completion Date
    December 7, 2018 (Anticipated)
    Study Completion Date
    December 7, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pearl Therapeutics, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD.
    Detailed Description
    This is a multicenter, randomized, double-blind, parallel-group, 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD. The study has a total of 7 visits over a Screening Period of up to 28 days and a Treatment Period of 12 weeks followed by a telephone follow-up call 14 days after the last dose of study drug.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BGF 320/14.4/9.6 µg MDI BID
    Arm Type
    Experimental
    Arm Description
    Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)
    Arm Title
    BFF 320/9.6 µg MDI BID
    Arm Type
    Experimental
    Arm Description
    Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)
    Intervention Type
    Drug
    Intervention Name(s)
    BGF 320/14.4/9.6 µg MDI
    Other Intervention Name(s)
    PT010
    Intervention Description
    Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)
    Intervention Type
    Drug
    Intervention Name(s)
    BFF 320/9.6 µg
    Other Intervention Name(s)
    PT009
    Intervention Description
    Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)
    Primary Outcome Measure Information:
    Title
    Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4)
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    Change from baseline in morning pre-dose trough FEV1
    Time Frame
    Week 12
    Title
    Peak change from baseline in inspiratory capacity
    Time Frame
    Week 12
    Title
    Percentage of subjects achieving a minimally clinical important difference (MCID) of 4 units or more in St. George's Respiratory Questionnaire (SGRQ)
    Time Frame
    Week 12
    Title
    Time to first clinically important deterioration (CID) in COPD
    Time Frame
    12 weeks
    Title
    Change from baseline in average daily rescue Ventolin HFA use
    Time Frame
    12 weeks
    Title
    Peak change from baseline in FEV1
    Time Frame
    Week 12
    Title
    Time to onset of action
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria: Signed Informed Consent Subjects with an established clinical history of COPD Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <80% predicted normal value All subjects must have been on 2 or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening Current or former smokers with a history of at least 10 pack-years of cigarette smoking Women of Non-childbearing potential Women of childbearing potential and sexually active agree to prevent pregnancy by using acceptable contraceptive methods consistently Key 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 Current diagnosis of asthma Uncontrolled sleep apnea Other Serious Respiratory Disorders Hospitalized due to poorly controlled COPD within 6 weeks Poorly Controlled COPD Immune deficiency and/or severe neurological disorders affecting control of the upper airway Hypersensitivity to β2-agonists, corticosteroids, or muscarinic anticholinergics
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Colin Reisner, MD
    Organizational Affiliation
    Pearl Therapeutics, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.

    Learn more about this trial

    To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

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