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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GFF MDI (PT003) with Aerochamber | Device | Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber |
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-12 on Day 8 | Pharmacokinetic Parameter AUC0-12 of Glycopyrronium by Treatment on Day 8 | Day 8 |
| AUC0-12 on Day 8 | Pharmacokinetic Parameter AUC0-12 of Formoterol by Treatment on Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colin Reisner | Pearl Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pearl Investigative Site | Clearwater | Florida | United States | |||
| Pearl Investigative Site |
Subject received one week of study treatment for each of the treatment periods, separated by a washout period of 7-14 days between treatments. Intent-to-treat (ITT) Population is used for Participant Flow. By-sequence tabulations of the data were not pre-specified.
This is a randomized, 2-period, open-label, chronic dosing (7 days), cross-over study conducted at 8 sites in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | All Randomized Patients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| GFF MDI (PT003) without Aerochamber | Device | Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber |
|
| Day 8 |
| Cmax on Day 8 | Pharmacokinetic Parameter Cmax of Glycopyrronium by Treatment on Day 8 | Day 8 |
| Cmax on Day 8 | Pharmacokinetic Parameter Cmax of Formoterol by Treatment on Day 8 | Day 8 |
| Tmax on Day 8 | Pharmacokinetic Parameter tmax of Glycopyrronium by Treatment on Day 8 | Day 8 |
| Tmax on Day 8 | Pharmacokinetic Parameter tmax of Formoterol by Treatment on Day 8 | Day 8 |
| Tampa |
| Florida |
| United States |
| Pearl Investigative Site | Winter Park | Florida | United States |
| Pearl Investigative Site | Charlotte | North Carolina | United States |
| Pearl Investigative Site | Winston-Salem | North Carolina | United States |
| Pearl Investigative Site | Gaffney | South Carolina | United States |
| GFF MDI (PT003) With Aerochamber |
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| GFF MDI (PT003) Without Aerochamber |
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| COMPLETED |
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| NOT COMPLETED |
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The Modified-Intent-to-Treat (MITT) Population is a subset of the Intent-to-Treat (ITT) Population including subjects who received treatment and had post-treatment efficacy data for both treatment periods and is used for the baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | MITT Population | The Modified ITT (MITT) Population is a subset of the ITT Population including subjects who received treatment and had post dose efficacy data from both Treatment Periods. Data judged to be impacted by major protocol deviations were determined prior to unblinding and excluded. Statistical tabulations and analyses are by randomized treatment, but data obtained after subjects received an incorrect treatment have been excluded from the affected periods. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The primary analysis used the Modified-Intent-to-Treat (MITT) Population. | Posted | Least Squares Mean | Standard Error | Liter | 7 days of treatment |
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| Secondary | AUC0-12 on Day 8 | Pharmacokinetic Parameter AUC0-12 of Glycopyrronium by Treatment on Day 8 | Pharmacokinetic Population | Posted | Mean | Standard Deviation | h*pg/mL | Day 8 |
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| Secondary | AUC0-12 on Day 8 | Pharmacokinetic Parameter AUC0-12 of Formoterol by Treatment on Day 8 | Pharmacokinetic Population | Posted | Mean | Standard Deviation | h*pg/mL | Day 8 |
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| Secondary | Cmax on Day 8 | Pharmacokinetic Parameter Cmax of Glycopyrronium by Treatment on Day 8 | Pharmacokinetic Population | Posted | Mean | Standard Deviation | pg/mL | Day 8 |
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| Secondary | Cmax on Day 8 | Pharmacokinetic Parameter Cmax of Formoterol by Treatment on Day 8 | Pharmacokinetic Population | Posted | Mean | Standard Deviation | pg/mL | Day 8 |
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| Secondary | Tmax on Day 8 | Pharmacokinetic Parameter tmax of Glycopyrronium by Treatment on Day 8 | Pharmacokinetic Population | Posted | Median | Full Range | h | Day 8 |
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| Secondary | Tmax on Day 8 | Pharmacokinetic Parameter tmax of Formoterol by Treatment on Day 8 | Pharmacokinetic Population | Posted | Median | Full Range | h | Day 8 |
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Adverse events collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
Any Adverse Events reported as starting during a Washout Period were assigned to the last randomized treatment received including those occurring during a Washout Period or the Follow-up Period. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GFF MDI (PT003) With Aerochamber | Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber | 1 | 74 | 3 | 74 | ||
| EG001 | GFF MDI (PT003) Without Aerochamber | Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber | 2 | 78 | 8 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood potassium increased | Investigations | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vessel puncture site swelling | General disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colin Reisner, MD, FCCP, FAAAAI | Pearl Therapeutics, Inc. | 650-305-2600 | creisner@pearltherapeutics.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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