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Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe COPD

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ClinicalTrials.gov Identifier: NCT02685293
Recruitment Status : Recruiting
First Posted : February 18, 2016
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Brief Summary:
This is a randomized, double-blind, placebo-controlled, single-center, chronic-dosing (7 days), two-period, two-treatment, cross-over study to evaluate the treatment effect of PT003 compared with that of Placebo MDI on Cardiovascular Hemodynamics following chronic-dosing (7 days) in subjects with moderate to severe COPD.

Condition or disease Intervention/treatment Phase
COPD Drug: GFF MDI (PT003) Drug: Placebo MDI Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Phase IIIb, Two-period , Double-blind, Two-treatment, Chronic-dosing (7 Days), Single-center Crossover Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease, Compared With Placebo
Actual Study Start Date : December 9, 2016
Estimated Primary Completion Date : May 3, 2019
Estimated Study Completion Date : October 18, 2019

Arm Intervention/treatment
Experimental: GFF MDI (PT003)
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)
Drug: GFF MDI (PT003)
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)

Placebo Comparator: Placebo MDI
Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol
Drug: Placebo MDI
Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol




Primary Outcome Measures :
  1. Right Ventricular End Diastolic Volume Index (RVEDVi) measured using Magnetic Resonance Imaging (MRI) at 2-3 hours post-dose on Day 8 [ Time Frame: 8 days ]
    RVEDVI is a measure of the volume of blood in the right ventricle at the end of diastole, normalized over body surface area and was measured using Cardiac Magnetic Resonance (CMR) imaging. RVEDVI is calculated as the right ventricular end diastolic volume (RDEDV) divided by the body surface area (BSA).


Secondary Outcome Measures :
  1. Aortic left ventricular stroke volume (LVSV) Measured using MRI at 2-3 hours post-dose on Day 8 [ Time Frame: 8 days ]
  2. Right Ventricular Stroke Volume (RVSV), phase contrast from pulmonic valve Measured using MRI at 2-3 hours post-dose on Day 8 [ Time Frame: 8 days ]
  3. Pulmonary Artery Velocity Measured using MRI at 2-3 hours post-dose on Day 8 [ Time Frame: 8 days ]
  4. Left Ventricular End Diastolic Volume Index (LVEDVi) Measured using MRI at 2-3 hours post-dose on Day 8 [ Time Frame: 8 days ]
  5. Cardiac Output Measured using MRI at 2-3 hours post-dose on Day 8 [ Time Frame: 8 days ]
  6. Morning Pre-dose trough and Post-dose Pulmonary Vascular Resistance (PVR) by Impedance CardiographyMeasured 30 minutes and 60 minutes post-dose on Day 8 [ Time Frame: 8 days ]
  7. Pulmonary artery/Aortic diameter ratio (PA:A) Measured using MRI at 2-3 hours post-dose on Day 8 [ Time Frame: 8 days ]
  8. Left Atrial End Diastolic Volume (LAEDV) Measured using MRI at 2-3 hours post-dose on Day 8 [ Time Frame: 8 days ]
  9. Left Atrial End Systolic Volume (LAESV) Measured using MRI at 2-3 hours post-dose on Day 8 [ Time Frame: 8 days ]
  10. Left Atrial Ejection Fraction (LAEF) Measured using MRI at 2-3 hours post-dose on Day 8 [ Time Frame: 8 days ]
  11. Left Ventricular End Systolic Volume Index (LVESVi) Measured using MRI at 2-3 hours post-dose on Day 8 [ Time Frame: 8 days ]
  12. Right Ventricular End Systolic Volume Index (RVESVi) Measured using MRI at 2-3 hours post-dose on Day 8 [ Time Frame: 8 days ]
  13. Pulsatility Index Aorta (PIAo) Measured using MRI at 2-3 hours post-dose on Day 8 [ Time Frame: 8 days ]
  14. Pulmonary Artery Pulsatility Index (PAPi) Measured using MRI at 2-3 hours post-dose on Day 8 [ Time Frame: 8 days ]


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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:

  • At least 40 years of age and no older than 80 at Visit 1.
  • Women of non-child bearing potential,or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly from Screening until 14 days after final visit
  • Evidence of lung hyperinflation
  • 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.
  • Pre- and Post-bronchodilator FEV1/FVC ratio must be <0.70
  • Post-bronchodilator FEV1 must be ≥30% to <65% predicted normal value, calculated using NHANES III reference equations.

Exclusion Criteria:

  • Significant diseases or conditions other than COPD which, in the opinion of the Investigator, may put the patient at risk
  • Women who are pregnant or lactating or are planning to become pregnant during the course of the study
  • Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma or other active pulmonary disease
  • Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Screening
  • 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 Screening or during the Screening Period
  • Subjects who have clinically significant uncontrolled hypertension.
  • Subjects with symptomatic prostatic hypertrophy that is clinically significant and not adequately controlled with appropriate therapy, in the opinion of the Investigator.
  • Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator.
  • Subjects with a calculated creatinine clearance ≤30 mL/minute using Chronic Kidney Disease Epidemiology Collaboration. (CKD-EPI) formula at Screening and on repeat testing prior to Visit 2.
  • Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥ 1.5 times upper limit of normal at Screening and on repeat testing prior to Visit 2
  • Subjects who have cancer that has not been in complete remission for at least five years.
  • Subjects with a diagnosis of glaucoma, who in the opinion of the Investigator, have not been adequately treated.
  • Subjects with a clinically significant ECG
  • Subjects who were previously enrolled in any previous PT001, PT003, or PT005 study conducted or sponsored by Pearl.

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): NCT02685293


Contacts
Contact: Catherine Pelc 8627778058

Locations
United States, Alabama
Pearl Investigative Site Not yet recruiting
Birmingham, Alabama, United States
United States, Colorado
Pearl Investigative site Recruiting
Denver, Colorado, United States
United States, Pennsylvania
Pearl Investigative Site Not yet recruiting
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
Study Chair: Colin Reisner, MD Pearl Therapeutics

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02685293     History of Changes
Other Study ID Numbers: PT003017
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. The policy and additional information can be found on astrazenecaclinicaltrials.com.
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
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