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The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PT003 (Dose 1) | Experimental | PT003 MDI Dose 1 |
|
| PT003 (Dose 2) | Experimental | PT003 MDI Dose 2 |
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| PT003 (Dose 3) | Experimental | PT003 MDI Dose 3 |
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| PT003 (Dose 4) | Experimental | PT003 MDI Dose 4 |
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| PT003 (Dose 5) | Experimental | PT003 MDI Dose 5 |
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| PT001 | Experimental | PT001 MDI |
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| PT005 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PT003 | Drug | PT003 MDI administered as two puffs BID for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 AUC 0-12 on Day 7 | FEV1 AUC 0-12 | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Change From Baseline in FEV1 on Treatment Day 1 | Peak change from Baseline in FEV1 on Treatment | Day 1 |
| Time to Onset of Action (>10% Improvement in FEV1) on Day 1 | Time to onset of action (>10% improvement in FEV1) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other inclusion/exclusion criteria as defined in the protocol
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| Name | Affiliation | Role |
|---|---|---|
| Colin Reisner, MD | Pearl Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pearl Investigative Site | Glendale | Arizona | United States | |||
| Pearl Investigative Site |
Study was a chronic dosing (7 days), 4-period, 8-treatment, Incomplete Block, Cross-Over.
The study was conducted at 20 sites in the US from May 2012 until September 2012. The entire study was scheduled to take a maximum of 19 weeks for each individual subject.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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PT005 MDI |
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| Spiriva® Handihaler® | Active Comparator | Tiotropium Bromide |
|
| PT001 | Drug | PT001 MDI administered as two puffs BID for 7 days |
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| PT005 | Drug | PT005 MDI administered as two puffs BID for 7 days |
|
| Tiotropium inhalation powder | Drug | Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days |
|
| Day 1 |
| Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1 | Proportion of subjects achieving >=12% improvement in FEV1 | Day 1 |
| Peak Change From Baseline in Inspiratory Capacity on Day 1 | Peak change from baseline in Inspiratory Capacity | Day 1 |
| Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7 | Change from baseline in morning pre-dose trough FEV1 | Day 7 |
| Peak Change From Baseline in FEV1 on Day 7 | Peak change from baseline in FEV1 Day 7 | Day 7 |
| Change From Baseline in Morning Pre-dose Trough IC on Day 7 | Change from baseline in morning pre-dose trough IC | Day 7 |
| Peak Change From Baseline IC on Day 7 | Peak change from baseline IC | Day 7 |
| Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7 | Change from baseline at evening 12-hour post-dose trough FEV1 | Day 7 |
| Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7 | Change from baseline in mean morning pre-dose daily peak flow readings | Day 7 |
| Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7 | Change from baseline in mean morning post-dose daily peak flow readings on | Day 7 |
| Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7 | Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only) | Day 7 |
| Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7 | Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva) | Day 7 |
| Rancho Mirage |
| California |
| United States |
| Pearl Investigative Site | Waterbury | Connecticut | United States |
| Pearl Investigative Site | Clearwater | Florida | 33765 | United States |
| Pearl Investigative Site | Clearwater | Florida | United States |
| Pearl Investigative Site | Pensacola | Florida | United States |
| Pearl Investigative Site | Winter Park | Florida | 32789 | United States |
| Pearl Investigative Site | Lafayette | Louisiana | United States |
| Pearl Investigative Site | North Dartmouth | Massachusetts | United States |
| Pearl Investigative Site | Fridley | Minnesota | United States |
| Pearl Investigative Site | St Louis | Missouri | United States |
| Pearl Investigative Site | Summit | New Jersey | United States |
| Pearl Investigative Site | Cincinnati | Ohio | United States |
| Pearl Investigative Site | Medford | Oregon | 97504 | United States |
| Pearl Investigative Site | Medford | Oregon | United States |
| Pearl Investigative Site | Rock Hill | South Carolina | United States |
| Pearl Investigative Site | Spartanburg | South Carolina | 29303 | United States |
| Pearl Investigative Site | San Antonio | Texas | United States |
| Pearl Investigative Site | Morgantown | West Virginia | United States |
| COMPLETED |
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| NOT COMPLETED |
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ITT/Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects Screened |
| 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 |
| |||||||||||||||||
| 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 | FEV1 AUC 0-12 on Day 7 | FEV1 AUC 0-12 | MITT | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Day 7 |
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| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in FEV1 on Treatment Day 1 | Peak change from Baseline in FEV1 on Treatment | MITT | Posted | Least Squares Mean | 95% Confidence Interval | Milliliters | Day 1 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Onset of Action (>10% Improvement in FEV1) on Day 1 | Time to onset of action (>10% improvement in FEV1) | MITT | Posted | Number | Percentage | Day 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1 | Proportion of subjects achieving >=12% improvement in FEV1 | MITT | Posted | Number | Percentage | Day 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in Inspiratory Capacity on Day 1 | Peak change from baseline in Inspiratory Capacity | MITT | Posted | Least Squares Mean | 95% Confidence Interval | Milliliters | Day 1 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7 | Change from baseline in morning pre-dose trough FEV1 | MITT | Posted | Least Squares Mean | 95% Confidence Interval | Milliliters | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in FEV1 on Day 7 | Peak change from baseline in FEV1 Day 7 | MITT | Posted | Least Squares Mean | 95% Confidence Interval | Millliters | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morning Pre-dose Trough IC on Day 7 | Change from baseline in morning pre-dose trough IC | MITT | Posted | Least Squares Mean | 95% Confidence Interval | Millliters | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline IC on Day 7 | Peak change from baseline IC | MITT | Posted | Least Squares Mean | 95% Confidence Interval | Millliters | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7 | Change from baseline at evening 12-hour post-dose trough FEV1 | MITT | Posted | Least Squares Mean | 95% Confidence Interval | Millliters | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7 | Change from baseline in mean morning pre-dose daily peak flow readings | MITT | Posted | Least Squares Mean | 95% Confidence Interval | L/min | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7 | Change from baseline in mean morning post-dose daily peak flow readings on | MITT | Posted | Least Squares Mean | 95% Confidence Interval | L/min | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7 | Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only) | MITT | Posted | Least Squares Mean | 95% Confidence Interval | L/min | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7 | Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva) | MITT | Posted | Least Squares Mean | 95% Confidence Interval | L/min | Day 7 |
|
SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
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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 | GP MDI 18 μg (PT001) | 18 μg | 1 | 66 | 8 | 66 | ||
| EG001 | GFF MDI 18/9.6 μg (PT003) | 18/9.6 μg | 1 | 71 | 2 | 71 | ||
| EG002 | GFF MDI 9/9.6 μg (PT003) | 9/9.6 μg | 0 | 70 | 8 | 70 | ||
| EG003 | GFF MDI 4.6/9.6 μg (PT003) | 4.6/9.6 μg | 0 | 67 | 5 | 67 | ||
| EG004 | GFF MDI 2.4/9.6 μg (PT003) | 2.4/9.6 μg | 1 | 71 | 9 | 71 | ||
| EG005 | GFF MDI 1.2/9.6 μg (PT003) | 1.2/9.6 μg | 2 | 68 | 2 | 68 | ||
| EG006 | FF MDI 9.6 μg (PT005) | 9.6 μg | 1 | 73 | 8 | 73 | ||
| EG007 | Spiriva | 18 μg | 0 | 71 | 6 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-Respiratory arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA | Systematic Assessment |
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| Spinal Compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Transient Ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Tremor | Nervous system 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 its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colin Resiner, 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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BID 1.2/9.6 μg
| OG006 | FF MDI BID 9.6 μg | BID 9.6 μg |
| OG007 | Spiriva 18 μg QD | 18 μg QD |
|
|
| OG006 | FF MDI BID 9.6 μg | BID 9.6 μg |
| OG007 | Spiriva 18 μg QD | 18 μg QD |
|
|
BID 1.2/9.6 μg
| OG006 | FF MDI BID 9.6 μg | BID 9.6 μg |
| OG007 | GP MDI 18 μg (PT001) | 18 μg |
|
|
BID 1.2/9.6 μg
| OG006 | FF MDI BID 9.6 μg | BID 9.6 μg |
| OG007 | Spiriva 18 μg QD | 18 μg QD |
|
|
BID 1.2/9.6 μg
| OG006 | FF MDI BID 9.6 μg | BID 9.6 μg |
| OG007 | Spiriva 18 μg QD | 18 μg QD |
|
|
BID 1.2/9.6 μg
| OG006 | FF MDI BID 9.6 μg | BID 9.6 μg |
| OG007 | Spiriva 18 μg QD | 18 μg QD |
|
|
BID 1.2/9.6 μg
| OG006 | FF MDI BID 9.6 μg | BID 9.6 μg |
| OG007 | Spiriva 18 μg QD | 18 μg QD |
|
|
| OG006 | FF MDI BID 9.6 μg | BID 9.6 μg |
| OG007 | Spiriva 18 μg QD | 18 μg QD |
|
|
BID 1.2/9.6 μg
| OG006 | FF MDI BID 9.6 μg | BID 9.6 μg |
| OG007 | Spiriva 18 μg QD | 18 μg QD |
|
|
1.2/9.6 μg BID |
| OG006 | FF MDI 9.6 μg BID | 9.6 μg BID |
| OG007 | Spiriva 18 μg QD | 18 μg QD |
|
|
1.2/9.6 μg BID |
| OG006 | FF MDI 9.6 μg BID | 9.6 μg BID |
| OG007 | Spiriva 18 μg QD | 18 μg QD |
|
|
1.2/9.6 μg BID |
| OG006 | FF MDI 9.6 μg BID | 9.6 μg BID |
| OG007 | Spiriva18 μg QD | 18 μg QD |
|
|
1.2/9.6 μg BID |
| OG006 | FF MDI 9.6 μg BID | 9.6 μg BID |
| OG007 | Spiriva 18 μg QD | 18 μg QD |
|
|