- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02454959
Crossover Study to Assess the Efficacy of PT003 With and Without a Valved Holding Chamber in Subjects With Moderate to Severe COPD
March 7, 2017 updated by: Pearl Therapeutics, Inc.
A Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multicenter, Crossover Study to Assess the Efficacy, Safety and Pharmacokinetics of PT003 in Subjects With Moderate to Very Severe COPD With and Without a Valved Holding Chamber
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Clearwater, Florida, United States
- Pearl Investigative Site
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Tampa, Florida, United States
- Pearl Investigative Site
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Winter Park, Florida, United States
- Pearl Investigative Site
-
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North Carolina
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Charlotte, North Carolina, United States
- Pearl Investigative Site
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Winston-Salem, North Carolina, United States
- Pearl Investigative Site
-
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South Carolina
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Gaffney, South Carolina, United States
- Pearl Investigative Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GFF MDI (PT003) with Aerochamber
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber
|
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber
|
Experimental: GFF MDI (PT003) without Aerochamber
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber
|
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 7 days of treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC0-12 on Day 8
Time Frame: Day 8
|
Pharmacokinetic Parameter AUC0-12 of Glycopyrronium by Treatment on Day 8
|
Day 8
|
AUC0-12 on Day 8
Time Frame: Day 8
|
Pharmacokinetic Parameter AUC0-12 of Formoterol by Treatment on Day 8
|
Day 8
|
Cmax on Day 8
Time Frame: Day 8
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Pharmacokinetic Parameter Cmax of Glycopyrronium by Treatment on Day 8
|
Day 8
|
Cmax on Day 8
Time Frame: Day 8
|
Pharmacokinetic Parameter Cmax of Formoterol by Treatment on Day 8
|
Day 8
|
Tmax on Day 8
Time Frame: Day 8
|
Pharmacokinetic Parameter tmax of Glycopyrronium by Treatment on Day 8
|
Day 8
|
Tmax on Day 8
Time Frame: Day 8
|
Pharmacokinetic Parameter tmax of Formoterol by Treatment on Day 8
|
Day 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Colin Reisner, Pearl Therapeutics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
March 25, 2016
Study Completion (Actual)
March 25, 2016
Study Registration Dates
First Submitted
May 13, 2015
First Submitted That Met QC Criteria
May 21, 2015
First Posted (Estimate)
May 27, 2015
Study Record Updates
Last Update Posted (Actual)
April 19, 2017
Last Update Submitted That Met QC Criteria
March 7, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- PT003013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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