NCT02454959

Brief Summary

This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to Severe COPD with and without a Valved Holding Chamber.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 19, 2017

Completed
Last Updated

April 19, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

May 13, 2015

Results QC Date

March 7, 2017

Last Update Submit

March 7, 2017

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • Area Under the Curve for Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) From 0 to 12 Hours (AUC0-12) on Day 8

    AUC0-12 was calculated using the trapezoidal rule based on FEV1 assessments at pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours post-dosing of study drug. Primary Outcome was calculated using the trapezoidal rule and was modeled conditionally on baseline FEV1.

    7 days of treatment

Secondary Outcomes (6)

  • AUC0-12 on Day 8

    Day 8

  • AUC0-12 on Day 8

    Day 8

  • Cmax on Day 8

    Day 8

  • Cmax on Day 8

    Day 8

  • Tmax on Day 8

    Day 8

  • +1 more secondary outcomes

Study Arms (2)

GFF MDI (PT003) with Aerochamber

EXPERIMENTAL

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber

Device: GFF MDI (PT003) with Aerochamber

GFF MDI (PT003) without Aerochamber

EXPERIMENTAL

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber

Device: GFF MDI (PT003) without Aerochamber

Interventions

GFF MDI (PT003) with AerochamberDEVICE

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber

GFF MDI (PT003) with Aerochamber
GFF MDI (PT003) without AerochamberDEVICE

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber

GFF MDI (PT003) without Aerochamber

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 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 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 Screening or during the Screening Period.
  • Subjects who have clinically significant uncontrolled hypertension.
  • Subjects who have cancer that has not been in complete remission for at least five years.
  • 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.
  • Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.
  • Subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator. Subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening are excluded from the study.
  • Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pearl Investigative Site

Clearwater, Florida, United States

Location

Pearl Investigative Site

Tampa, Florida, United States

Location

Pearl Investigative Site

Winter Park, Florida, United States

Location

Pearl Investigative Site

Charlotte, North Carolina, United States

Location

Pearl Investigative Site

Winston-Salem, North Carolina, United States

Location

Pearl Investigative Site

Gaffney, South Carolina, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Colin Reisner, MD, FCCP, FAAAAI
Organization
Pearl Therapeutics, Inc.
creisner@pearltherapeutics.com
650-305-2600

Study Officials

  • Colin Reisner

    Pearl Therapeutics

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

May 27, 2015

Study Start

May 1, 2015

Primary Completion

March 25, 2016

Study Completion

March 25, 2016

Last Updated

April 19, 2017

Results First Posted

April 19, 2017

Record last verified: 2017-03

Locations

US(6)