Gold River, California 95670

  • COPD

Purpose:

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 summary:

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.


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.


Study is Available At:


Original ID:

PT010006


NCT ID:

NCT02497001


Secondary ID:


Study Acronym:

KRONOS


Brief 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 C


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

40 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pearl Therapeutics, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

1900


Enrollment Type:

Actual


Overall Contact Information

Official Name:Paul Dorinsky, MD
Study Director
Pearl Therapeutics, Inc.

Study Dates

Start Date:August 10, 2015
Completion Date:January 5, 2018
Completion Type:Actual
Primary Completion Date:January 5, 2018
Primary Completion Type:Actual
Verification Date:February 2019
Last Changed Date:February 14, 2019
First Received Date:July 8, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Time to onset of action
Time Frame:Day 1
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of moderate or severe COPD exacerbations
Time Frame:24 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Peak change from baseline in FEV1 within 4 hours post-dosing
Time Frame:Week 24
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in average daily rescue Ventolin HFA use
Time Frame:24 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of subjects achieving an MCID (Minimal Clinically Important Difference) of 4 units or more in SGRQ total score (SGRQ responders)
Time Frame:Week 24
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in morning pre-dose trough FEV1
Time Frame:24 Weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change from baseline in morning pre-dose trough FEV1
Time Frame:Week 24
Safety Issues:False
Outcome Type:Primary Outcome
Measure:FEV1 AUC0-4
Time Frame:Week 24
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:BGF MDI 320/14.4/9.6 μg
Description:Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
Arm Name:BGF MDI (PT010) 320/14.4/9.6 μg ex-actuator
Other Name:BGF
Intervention Type:Drug
Name:GFF MDI (PT003) 14.4/9.6 μg
Description:Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
Arm Name:GFF MDI (PT003) 14.4/9.6 μg ex-actuator
Other Name:GFF
Intervention Type:Drug
Name:BFF MDI (PT009) 320/9.6 μg
Description:Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
Arm Name:BFF MDI (PT009) 320/9.6 μg ex-actuator
Other Name:BFF
Intervention Type:Drug
Name:Symbicort® Turbuhaler® (TBH) Inhalation Powder
Arm Name:Symbicort

Study Arms

Study Arm Type:Active Comparator
Arm Name:Symbicort
Description:Symbicort® Turbuhaler® (TBH) Inhalation Powder 200/6 μg
Study Arm Type:Experimental
Arm Name:BFF MDI (PT009) 320/9.6 μg ex-actuator
Description:BFF MDI 320/9.6 μg, Budesonide, Formoterol Fumarate Inhalation Aerosol
Study Arm Type:Experimental
Arm Name:GFF MDI (PT003) 14.4/9.6 μg ex-actuator
Description:GFF MDI 14.4/9.6 μg ex-actuator Glycopyrronium, Formoterol Fumarate Inhalation Aerosol
Study Arm Type:Experimental
Arm Name:BGF MDI (PT010) 320/14.4/9.6 μg ex-actuator
Description:BGF MDI 320/14.4/9.6 μg,Budesonide, Glycopyrronium, Formoterol Fumarate Inhalation Aerosol

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pearl Therapeutics, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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