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A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD

Primary Purpose

COPD, Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

GP MDI (PT001) 14.4 μg

FF MDI (PT005) 9.6 μg

About this trial

This is an interventional treatment trial for COPD, Chronic Obstructive Pulmonary Disease

Eligibility Criteria

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

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 urine pregnancy test at Visit 1, and agrees to use acceptable contraceptive methods used consistently and correctly
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.
At Visit 1, FEV1/FVC ratio must be <0.70
At Visit 1, post-bronchodilator FEV1must be >30% and <80% predicted normal value, calculated using The Third National Health and Nutrition Examination Survey (NHANES III) reference equations.

Exclusion criteria:

Significant diseases other than COPD, i.e., disease or condition 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 run-in period (Visit 1 to Visit 2).
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 run-in period (Visit 1 to Visit 2).
Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated.
Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.

Sites / Locations

Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GP MDI (PT001) 14.4 μg

FF MDI (PT005) 9.6 μg

Arm Description

Glycopyrronium

Formoterol Fumarate

Outcomes

Primary Outcome Measures

Specific Image-Based Airway Volume (siVaw)

Specific image-based airway volume. Average across lobe, adjusted for lobe volume. Ratio to baseline

Specific Image-based Airway Resistance (siRaw)

Specific image-based airway resistance (siRaw). Average across lobes, adjusted for lobe volume. Ratio to baseline.

Secondary Outcome Measures

Image-based Airway Volume (iVaw)

Image-based airway volume (iVaw) without correction for lobe volume. Ratio to baseline.

Image-based Airway Resistance (iRaw)

Image-based airway resistance (iRaw) without correction for lobe volume. Ratio to baseline.

FEV1

FEV1 Change from baseline in Forced Expiratory Volume at 1 second.

Functional Residual Capacity (FRC)

Functional residual capacity (FRC). Ratio to baseline.

Full Information

NCT ID

NCT02937584

First Posted

October 17, 2016

Last Updated

June 28, 2019

Sponsor

Pearl Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02937584

Brief Title

A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD

Official Title

A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Multi-Center Study to Evaluate the Effects of PT001 and PT005 on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

December 29, 2016 (Actual)

Primary Completion Date

May 28, 2018 (Actual)

Study Completion Date

May 28, 2018 (Actual)

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

Data Monitoring Committee

5. Study Description

Brief Summary

To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID) and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after approximately two weeks treatment.

6. Conditions and Keywords

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

COPD, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GP MDI (PT001) 14.4 μg

Arm Type

Experimental

Arm Description

Glycopyrronium

Arm Title

FF MDI (PT005) 9.6 μg

Arm Type

Experimental

Arm Description

Formoterol Fumarate

Intervention Type

Drug

Intervention Name(s)

GP MDI (PT001) 14.4 μg

Intervention Description

Glycopyrronium

Intervention Type

Drug

Intervention Name(s)

FF MDI (PT005) 9.6 μg

Intervention Description

Formoterol Fumarate

Primary Outcome Measure Information:

Title

Specific Image-Based Airway Volume (siVaw)

Description

Specific image-based airway volume. Average across lobe, adjusted for lobe volume. Ratio to baseline

Time Frame

Baseline, Day 15

Title

Specific Image-based Airway Resistance (siRaw)

Description

Specific image-based airway resistance (siRaw). Average across lobes, adjusted for lobe volume. Ratio to baseline.

Time Frame

Baseline, Day 15

Secondary Outcome Measure Information:

Title

Image-based Airway Volume (iVaw)

Description

Image-based airway volume (iVaw) without correction for lobe volume. Ratio to baseline.

Time Frame

Baseline, Day 15

Title

Image-based Airway Resistance (iRaw)

Description

Image-based airway resistance (iRaw) without correction for lobe volume. Ratio to baseline.

Time Frame

Baseline, Day 15

Title

FEV1

Description

FEV1 Change from baseline in Forced Expiratory Volume at 1 second.

Time Frame

Baseline, Day 15

Title

Functional Residual Capacity (FRC)

Description

Functional residual capacity (FRC). Ratio to baseline.

Time Frame

Baseline, Day 15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 urine pregnancy test at Visit 1, and agrees to use acceptable contraceptive methods used consistently and correctly 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. At Visit 1, FEV1/FVC ratio must be <0.70 At Visit 1, post-bronchodilator FEV1must be >30% and <80% predicted normal value, calculated using The Third National Health and Nutrition Examination Survey (NHANES III) reference equations. Exclusion criteria: Significant diseases other than COPD, i.e., disease or condition 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 run-in period (Visit 1 to Visit 2). 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 run-in period (Visit 1 to Visit 2). Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chad Orevillo

Organizational Affiliation

Pearl Therapeutics

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Research Site

City

Erpent

ZIP/Postal Code

5101

Country

Belgium

12. IPD Sharing Statement

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4186&filename=PT003019-01_FLUI-2015-140_Protocol_10%20August_Redacted_PDFA.pdf

Description

Related Info

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4186&filename=PT003019-sap-16APR2018-Redacted_PDFA.pdf

Description

Related Info

Learn more about this trial

A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD

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