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

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.

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.

Study Overview

• Status: Completed
• Conditions: COPD, Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: GP MDI (PT001) 14.4 μg; Drug: FF MDI (PT005) 9.6 μg

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Research Site
  • Erpent, Belgium, 5101
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GP MDI (PT001) 14.4 μg; Glycopyrronium	Drug: GP MDI (PT001) 14.4 μg; Glycopyrronium
EXPERIMENTAL: FF MDI (PT005) 9.6 μg; Formoterol Fumarate	Drug: FF MDI (PT005) 9.6 μg; Formoterol Fumarate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific Image-Based Airway Volume (siVaw)	Specific image-based airway volume. Average across lobe, adjusted for lobe volume. Ratio to baseline	Baseline, Day 15
Specific Image-based Airway Resistance (siRaw)	Specific image-based airway resistance (siRaw). Average across lobes, adjusted for lobe volume. Ratio to baseline.	Baseline, Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image-based Airway Volume (iVaw)	Image-based airway volume (iVaw) without correction for lobe volume. Ratio to baseline.	Baseline, Day 15
Image-based Airway Resistance (iRaw)	Image-based airway resistance (iRaw) without correction for lobe volume. Ratio to baseline.	Baseline, Day 15
FEV1	FEV1 Change from baseline in Forced Expiratory Volume at 1 second.	Baseline, Day 15
Functional Residual Capacity (FRC)	Functional residual capacity (FRC). Ratio to baseline.	Baseline, Day 15

Collaborators and Investigators

• Sponsor: Pearl Therapeutics, Inc.

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 29, 2016
• Primary Completion (ACTUAL): May 28, 2018
• Study Completion (ACTUAL): May 28, 2018

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (ESTIMATE): October 18, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2019
• Last Update Submitted That Met QC Criteria: June 28, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PT003019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No