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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)

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ClinicalTrials.gov Identifier: NCT02497001
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

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 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

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 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 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
BF MDI 320/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate 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



Primary Outcome Measures :
  1. Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) [ Time Frame: 24 Weeks ]

Secondary Outcome Measures :
  1. FEV1 area under the curve from 0 to 4 hours (AUC0-4) [ Time Frame: 24 Weeks ]
  2. Transition dyspnea index (TDI) focal score [ Time Frame: 24 Weeks ]
  3. St. George Respiratory Questionnaire (SGRQ) [ Time Frame: 24 Weeks ]
  4. Rescue Ventolin HFA use [ Time Frame: 24 Weeks ]
  5. Peak FEV1 within 4 hours post-dosing [ Time Frame: 24 Weeks ]
  6. The EXAcerbations of Chronic pulmonary disease Tool (EXACT) total score [ Time Frame: 24 Weeks ]
  7. Time to onset of action on Day 1 [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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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.


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


  Show 111 Study Locations
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
Study Director: Colin Reisner Pearl Therapeutics, Inc.

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02497001     History of Changes
Other Study ID Numbers: PT010006
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: http://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists