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This is an open-label, multi-center study to evaluate the accuracy, reliability and functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler | Experimental | Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler (GFF MDI), PT003 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler | Drug | GFF MDI administered as 2 inhalations BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count | Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit: ITT Population | Over the life of the canister/120 puffs - up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit | Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight | Over the life of the canister/120 puffs - up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colin Reisner, MD | Pearl Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pearl Investigative Site | Clearwater | Florida | United States | |||
| Pearl Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30335559 | Derived | Pudi K, Feldman G, Fakih F, Mack P, Maes A, Siddiqui S, St Rose E, Reisner C. An Open-Label Study Evaluating the Performance of the Dose Indicator in a Metered Dose Inhaler Delivering Glycopyrrolate and Formoterol Fumarate in Patients with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease. J Aerosol Med Pulm Drug Deliv. 2019 Feb;32(1):40-46. doi: 10.1089/jamp.2018.1466. Epub 2018 Nov 1. |
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Study was an open-label, multi center study to evaluate the accuracy, reliability, and functionality of GFF MDI dose indicator in adult subjects with moderate to very severe COPD over a 4-week treatment period.
Conducted at 10 study sites in the United states from November 2014 - January 2015. The entire study period was scheduled to take approximately 6 weeks for each individual subject. The study was anticipated to run for approximately 6 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | GFF MDI (PT003) | GFF MDI 14.4/9.6 μg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Percentage of Devices in Agreement Between Laboratory-Advanced Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit | Percentage of devices whose number of actuations counted at the end of the study, using the lab-advanced dose indicator reading, was consistent (±20 actuations) with the number of actuations used as reported by the subject | Over the life of the canister/120 puffs - up to 4 weeks |
| Percentage of Devices in Agreement Between Laboratory-advanced Does Indicator Actuation and Weight-based Actuation Count at Last Available Visit. | Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight | Over the life of the canister/120 puffs - up to 4 weeks |
| Percentage of Devices Where the Dose Indicator Actuation Count is >20 Less Than the Subject-reported Actuation Count (Undercount) | Percentage of devices where the dose indicator actuation count is >20 less than the subject-reported actuation count (undercount) | Over the life of the canister/120 puffs - up to 4 weeks |
| Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count | Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count | Over the life of the canister/120 puffs - up to 4 weeks |
| Tampa |
| Florida |
| United States |
| Pearl Investigative Site | Winter Park | Florida | United States |
| Pearl Investigative Site | Charlotte | North Carolina | United States |
| Pearl Investigative Site | Columbus | Ohio | United States |
| Pearl Investigative Site | Medford | Oregon | United States |
| Pearl Investigative Site | Greenville | South Carolina | United States |
| Pearl Investigative Site | Rock Hill | South Carolina | United States |
| Pearl Investigative Site | Spartanburg | South Carolina | United States |
| Pearl Investigative Site | Richmond | Virginia | United States |
| COMPLETED |
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| NOT COMPLETED |
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126 received treatment on Day 1 and 29, 10 prematurely discontinued, 2 with no assessment on Day 29.
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| ID | Title | Description |
|---|---|---|
| BG000 | GFF MDI (PT003) | GFF MDI 14.4/9.6 μg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Gender | 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 | Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count | Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit: ITT Population | ITT Population | Posted | Number | Percentage | Over the life of the canister/120 puffs - up to 4 weeks |
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| Secondary | Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit | Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight | ITT Population | Posted | Number | Percentage of Devices | Over the life of the canister/120 puffs - up to 4 weeks |
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| Secondary | Percentage of Devices in Agreement Between Laboratory-Advanced Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit | Percentage of devices whose number of actuations counted at the end of the study, using the lab-advanced dose indicator reading, was consistent (±20 actuations) with the number of actuations used as reported by the subject | ITT Population | Posted | Number | Percentage of devices | Over the life of the canister/120 puffs - up to 4 weeks |
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| Secondary | Percentage of Devices in Agreement Between Laboratory-advanced Does Indicator Actuation and Weight-based Actuation Count at Last Available Visit. | Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight | ITT Population | Posted | Number | Percentage | Over the life of the canister/120 puffs - up to 4 weeks |
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| Secondary | Percentage of Devices Where the Dose Indicator Actuation Count is >20 Less Than the Subject-reported Actuation Count (Undercount) | Percentage of devices where the dose indicator actuation count is >20 less than the subject-reported actuation count (undercount) | ITT Population | Posted | Number | Percentage | Over the life of the canister/120 puffs - up to 4 weeks |
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| Secondary | Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count | Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count | ITT Population | Posted | Number | Percentage of correct advances | Over the life of the canister/120 puffs - up to 4 weeks |
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AEs occurring between when signed consent and randomized reported as SAEs up to 14 days following last dose of study drug. AEs occurring at time of and following first study drug administration were reported and followed until stabilized/resolved.
Safety population included all participants who received at least one dose of investigational drug and had safety data available (Note: A subject who used the GFF MDI, but took less than 1 full dose of treatment qualified for this population.)
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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) | GFF MDI 14.4/9.6 μg | 3 | 138 | 10 | 138 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Chronic Obstructive pulmonary disease |
|
| Metastatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastatic Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Chronic Obstructive Pulmonary disease |
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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 its 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 | 973-975-0320 | 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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| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Correct within ±2 actuations |
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| Correct within ±4 actuations |
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