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Trial record 1 of 1 for:    NCT02497001
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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)

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: NCT02497001
Recruitment Status : Completed
First Posted : July 14, 2015
Results First Posted : December 24, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COPD 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 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1902 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 10, 2015
Actual Primary Completion Date : January 5, 2018
Actual Study Completion Date : January 5, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: BFF
Active Comparator: Symbicort
Symbicort® Turbuhaler® (TBH) Inhalation Powder 200/6 μg
 Drug: Symbicort® Turbuhaler® (TBH) Inhalation Powder


Outcome Measures
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Primary Outcome Measures :
  1. FEV1 AUC0-4 [ Time Frame: at Week 24 ]
    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)).

  2. Change From Baseline in Morning Pre-dose Trough FEV1 [ Time Frame: at Week 24 ]
    Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand


Secondary Outcome Measures :
  1. Change From Baseline in Morning Pre-dose Trough FEV1 [ Time Frame: over 24 Weeks ]
    Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand

  2. Peak Change From Baseline in FEV1 Within 4 Hours Post-dosing [ Time Frame: at Week 24 ]
    Peak Change from Baseline in FEV1 (L) Within 4 Hours Post-Dose for The Efficacy Estimand

  3. Rate of Moderate or Severe COPD Exacerbations [ Time Frame: over 24 weeks ]
    Rate of Moderate or Severe COPD Exacerbations for the Efficacy Estimand

  4. Percentage of Subjects Achieving a Minimal Clinically Important Difference (MCID) of 4 Units or More in SGRQ Total Score (SGRQ Responders) [ Time Frame: at Week 24 ]
    Change from BGF

  5. Change From Baseline in Average Daily Rescue Ventolin HFA Use [ Time Frame: over 24 Weeks ]
    Change from Baseline in Mean Daily Number of Puffs of Rescue Ventolin HFA for The Efficacy Estimand

  6. Time to Onset of Action on Day 1, 5 Minutes Post Dose [ Time Frame: Day 1 ]
    FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand

  7. Time to Onset of Action on Day 1, 15 Minutes Post Dose [ Time Frame: Day 1 ]
    FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand

  8. Time to Onset of Action on Day 1, 30 Minutes Post Dose [ Time Frame: Day 1 ]
    FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand

  9. Time to Onset of Action on Day 1, 1 Hour Post Dose [ Time Frame: Day 1 ]
    FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand

  10. Time to Onset of Action on Day 1, 2 Hours Post Dose [ Time Frame: Day 1 ]
    FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand

  11. Time to Onset of Action on Day 1, 4 Hours Post Dose [ Time Frame: Day 1 ]
    FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497001


Locations
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Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
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Study Director: Paul Dorinsky, MD Pearl Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Pearl Therapeutics, Inc.:
Statistical Analysis Plan  [PDF] January 9, 2018
Study Protocol  [PDF] August 25, 2017

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02497001    
Other Study ID Numbers: PT010006
First Posted: July 14, 2015    Key Record Dates
Results First Posted: December 24, 2020
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Budesonide, Formoterol Fumarate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents