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This is a long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week, open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice a day or Spiriva® [tiotropium] given as 18 mcg once a day).
This is a Phase 3, randomized, open-label, active-controlled, parallel-group, multicenter, long-term safety trial of 48 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer or Spiriva in approximately 1050 subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.
Eligible subjects will enter the 48-week, open-label treatment period following randomization to receive one of two treatments (SUN-101 given as 50 mcg BID or Spiriva® [tiotropium] given as 18 mcg QD).
The hypothesis for this study is that the incidence of treatment-emergent adverse events reported over the course of 48 weeks of treatment by subjects randomized to SUN-101 is numerically similar to the incidence of treatment-emergent adverse events reported over the course of 48 weeks of treatment by subject randomized to Spiriva (tiotropium).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUN-101 50 mcg BID eFlow (CS) nebulizer | Experimental | SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer |
|
| Spiriva 18 mcg QD Handihaler | Active Comparator | Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUN-101 50 mcg BID eFlow (CS) nebulizer | Drug | SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Treatment-emergent Adverse Events (TEAE) | A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date. | Up to Week 48 |
| Percentage of Subjects With Treatment-emergent Adverse Events | A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date. | Up to Week 48 |
| Number of Subjects With Treatment-emergent Serious Adverse Events (SAE) | A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date. | Up to Week 48 |
| Percentage of Subjects With Treatment-emergent Serious Adverse | A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date. | Up to Week 48 |
| Number of Subjects Who Discontinue the Study Due to TEAE | A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date. | Up to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke | All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Respiratory Medical Director | Sunovion Respiratory Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SEC Lung LLC | Andalusia | Alabama | 36420 | United States | ||
| Achieve Clinical Research LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28919143 | Result | Ferguson GT, Goodin T, Tosiello R, Wheeler A, Kerwin E. Long-term safety of glycopyrrolate/eFlow(R) CS in moderate-to-very-severe COPD: Results from the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) 5 randomized study. Respir Med. 2017 Nov;132:251-260. doi: 10.1016/j.rmed.2017.08.020. Epub 2017 Aug 24. | |
| 30584583 |
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| ID | Title | Description |
|---|---|---|
| FG000 | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer |
| FG001 | Spiriva 18 mcg QD Handihaler |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Spiriva® 18 mcg QD Handihaler | Drug | Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler |
|
|
| Percentage of Subjects Who Discontinue the Study Due to TEAE | A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date. | Up to 48 Weeks |
| Up to Week 48 |
| Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke | All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact. | Up to 48 Weeks |
| Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke | All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact. | up to week 48 |
| Mean Change From Baseline Over 48 Weeks in Trough FEV1 for All Subjects | Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the FEV1 values collected at the end of the dosing interval at each clinic visit. The mean change from baseline in trough FEV1 over the 48 week treatment period is calculated by averaging the trough FEV1 changes from baseline across all study visits while subjects are taking randomized treatment. Values affected by other medication use were to be set to missing. | Up to Week 48 |
| Birmingham |
| Alabama |
| 35216 |
| United States |
| Jasper Summit Research LLC | Jasper | Alabama | 35501 | United States |
| Clinical Research Advantage, Inc.lEast Valley Family Physicians, PLC | Chandler | Arizona | 85224 | United States |
| Desert Sun Clinical Research LLC | Tucson | Arizona | 85710 | United States |
| Allianz Research Institute, Inc. | Fountain Valley | California | 92708 | United States |
| Research Center of Fresno, Inc. | Fresno | California | 93702 | United States |
| California Research Medical Group, lnc. | Fullerton | California | 92835 | United States |
| Southern California Institute For Respiratory Diseases, Inc. | Los Angeles | California | 90048 | United States |
| Integrated Research Group, Inc | Riverside | California | 92506 | United States |
| Institute of Healthcare Assessments Inc. | San Diego | California | 92120 | United States |
| Waterbury Pulmonary Associates, LLC | Waterbury | Connecticut | 06708 | United States |
| Tampa Bay Clinical Research Center | Brandon | Florida | 33511 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| Avail Clinical Research, llC | DeLand | Florida | 32720 | United States |
| The Community Research of South Florida | Hialeah | Florida | 33016 | United States |
| AppleMed Research, Inc | Miami | Florida | 33155 | United States |
| Research Institute of South Florida, Inc | Miami | Florida | 33173 | United States |
| Clinical Trials of Florida, LLC | Miami | Florida | 33186 | United States |
| Florida Institute For Clinical Research, LLC | Orlando | Florida | 32825 | United States |
| Ribo Research, LLC dba Peninsula Research, Inc. | Ormond Beach | Florida | 32174 | United States |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33603 | United States |
| Clinical Research of West Florida | Tampa | Florida | 33603 | United States |
| Vero Lung Center | Vero Beach | Florida | 32960 | United States |
| Gwinnett Biomedical Research | Lawrenceville | Georgia | 30046 | United States |
| H.C. Research LLC | Coeur d'Alene | Idaho | 83814 | United States |
| Evanston Premier Healthcare Research LLC | Evanston | Illinois | 60201 | United States |
| Asthma and Allergy Center of Chicago SC | River Forest | Illinois | 60305 | United States |
| LaPorte County Institute For Clinical Research | Michigan City | Indiana | 46360 | United States |
| Buynak Clinical Research, P.C. | Valparaiso | Indiana | 46383 | United States |
| Abraham Research, PLLC | Fort Mitchell | Kentucky | 41017 | United States |
| Kentucky Lung Clinics, PSC | Hazard | Kentucky | 41701 | United States |
| Bendel Medical Research Center, LLC | Lafayette | Louisiana | 70508 | United States |
| New Orleans Center for Clinical Research | New Orleans | Louisiana | 70119 | United States |
| Howard County Center for Lung and Sleep Medicine, LLC | Columbia | Maryland | 21044 | United States |
| Pulmonary and Critical Care Associates of Baltimore | Towson | Maryland | 21204 | United States |
| Cadillac Clinical Research LLC | Cadillac | Michigan | 49601 | United States |
| Pulmonary Research Institute of Southeast Michigan | Livonia | Michigan | 48152 | United States |
| Minnesota Lung Center | Edina | Minnesota | 55435 | United States |
| Clinical Research Institute, Inc. | Minneapolis | Minnesota | 55402 | United States |
| Minnesota Lung Center | Minneapolis | Minnesota | 55407 | United States |
| Minnesota Lung Center | Woodbury | Minnesota | 55125 | United States |
| Midwest Chest Consultants PC | Saint Charles | Missouri | 63301 | United States |
| CARE Clinical Research | St Louis | Missouri | 63141 | United States |
| Midwest Clinical Research LLC | St Louis | Missouri | 63141 | United States |
| The Clinical Research Center | St Louis | Missouri | 63141 | United States |
| Somnos Laboratories, Inc d/b/a Somnos Clinical Research | Lincoln | Nebraska | 68510 | United States |
| Clinical Research Advantage Inc | Las Vegas | Nevada | 89128 | United States |
| Delaware Valley Clinical Research, LLC | Marlton | New Jersey | 08053 | United States |
| Atlantic Research Center, LLC | Ocean City | New Jersey | 07712 | United States |
| Pulmonary and Allergy Associates, PA | Summit | New Jersey | 07901 | United States |
| ISA Clinical Research | Jamaica | New York | 11435 | United States |
| American Health Research, Inc. | Charlotte | North Carolina | 28207 | United States |
| ARSM Research | Huntersville | North Carolina | 28078 | United States |
| Clinical Research of Lake Norman | Huntersville | North Carolina | 28078 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | United States |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | United States |
| Lillestol Research, LLC | Fargo | North Dakota | 58103 | United States |
| IVA Researcb | Cincinnati | Ohio | 45245 | United States |
| Remington Davis Inc | Columbus | Ohio | 43215 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Clinical Research Institute of Southern Oregon, PC | Medford | Oregon | 97504 | United States |
| Sunstone Medical Research, L.LC | Medford | Oregon | 97504 | United States |
| Allergy Associates Research Center | Portland | Oregon | 97202 | United States |
| Lowcountry Lung and Critical Care, PA | Charleston | South Carolina | 29406 | United States |
| Easley Clinical Research | Easley | South Carolina | 29640 | United States |
| Palmetto Medical Research Associates | Easley | South Carolina | 29640 | United States |
| Gaffney Pharmaceutical Research | Gaffney | South Carolina | 29340 | United States |
| Spectrum Medical Research, LLC | Gaffney | South Carolina | 29341 | United States |
| Greenville Pharmaceutical Research, Inc. | Greenville | South Carolina | 29615 | United States |
| Upstate Pharmaceutical Research, Inc. | Greenville | South Carolina | 29615 | United States |
| DeGarmo Institute of Medical Research | Greer | South Carolina | 29651 | United States |
| Clinical Research of Charleston | Mt. Pleasant | South Carolina | 29464 | United States |
| Hope Clinical Research | Seneca | South Carolina | 29678 | United States |
| S. Carolina Pharmaceutical Research | Spartanburg | South Carolina | 29303 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| CU Pharmaceutical Research | Union | South Carolina | 29379 | United States |
| New Phase Clinical Research & Development | Knoxville | Tennessee | 37919 | United States |
| Corsicana Medical Research, PLLC | Corsicana | Texas | 75110 | United States |
| Pioneer Research Solutions, Inc | Houston | Texas | 77099 | United States |
| Alamo Clinical Research Associates | San Antonio | Texas | 78212 | United States |
| Pulmonary Consultants PLLC | Tacoma | Washington | 98405 | United States |
| Medicentrum Beroun s.r o. | Beroun | 266 01 | Czechia |
| MediTrial, s.r.o Internf a pneumoloqicka ambulance | Jindřichův Hradec | 377 01 | Czechia |
| Nemocnice Kyjov, p.o. | Kyjov | 69733 | Czechia |
| Plicni ambulance | Neratovice | 277 11 | Czechia |
| MephaCentrum, a s Plicni oddeleni | Ostrava - Poruba | 708 00 | Czechia |
| MephaCentrum, a.s. | Ostrava-Poruba | 708 00 | Czechia |
| PNEUMa-HOST s LO. | Prague | 158 00 | Czechia |
| PLiCNI AMBULANCE ROKYCANY, s.r o. | Rokycany | 337 01 | Czechia |
| Hrudnf ambulance s.r.o. | Žatec | 438 01 | Czechia |
| Dr. Kenessey Albert Korhaz-Rendetointezet, TOd6gy6gyaszati | Balassagyarmat | H-2660 | Hungary |
| Csornai Margit Korhaz, TOd6gy6gyaszat | Csorna | H-9300 | Hungary |
| Kenezy Gyula Korhaz es Rendelomtezet, Klinikai Farmakologiai | Debrecen | H-4043 | Hungary |
| Veszprern Megyei Tudbgyogyintezet | Farkasgyepű | H-8582 | Hungary |
| Somogy Megyei Kaposi M6r Oktat6 Korhaz, Tudoqondozo | Kaposvár | H-7400 | Hungary |
| Lumniczer Sandor Korhaz as Rendelointezet, Tudoqondozo | Kapuvár | H-9330 | Hungary |
| Selye Janos Korhaz es Rendelointezet, Tud6gy6gyaszati Szakrendeles | Komárom | H-2900 | Hungary |
| Szakorvosi Rendelointezet Monor, Tudoqondozo | Monor | H-2200 | Hungary |
| Revamed Eqeszsequqyi Szolqaltato Kft. | Nyíregyháza | H-4400 | Hungary |
| Si6fok Kornaz-Rendelointezet, Tudoqondozo | Siófok | H-8600 | Hungary |
| Farmakontroll Egeszsegugyi Szolqaltato Bt | Százhalombatta | H-2440 | Hungary |
| Csonqrad Megyei Mellkasi Beteqseqek Szakkorhaza, Tudoqondozo lntezet | Szeged | H-6722 | Hungary |
| Territorial SBI of Healthcare <Territorial Clinical Hospital> | Barnaul | 656024 | Russia |
| FSBI Far Eastern Research Centre ofPhysiology and Pathology of Breathing of Siberian branch of RAMS | Blagoveshchensk | 675000 | Russia |
| SBI of Healthcare Regional Clinical Hospital #4 City consultative department for pulmonological patientsr | Chelyabinsk | 454021 | Russia |
| Municipal Budget Institution of Healthcare (City Clinical Hospital #3 n.a. M.A. Podgorbunsky) | Kemerovo | 650000, | Russia |
| FSSI Scientific Research Institute of Complex Cardiovascular Pathology | Kemerovo | 650002 | Russia |
| FSBI | Moscow | 115682 | Russia |
| Non-State Private Institution of Healthcare <Scientific Clinical Center> | Moscow | 125315 | Russia |
| SBI of Healthcare of Nizhny-Novgorod region | Nizhny Novgorod | 603126 | Russia |
| SB1 of Healthcare of Novosibirsk region <Novosibirsk State Regional Clinical Hospital>l | Novosibirsk | 630087 | Russia |
| SBI of Healthcare of Novosibirsk region <Novosibirsk State Regional Clinical Hospital> | Novosibirsk | 630087 | Russia |
| Alliance Biomedical, Russian Group LLC | Saint Petersburg | 194358 | Russia |
| SBEI of HPE <North-West State Medical University n.a. LL Mechnikov> | Saint Petersburg | 195067 | Russia |
| SBr of Helathcareof Yaraslavl region Clinical Hospital of Emervency care n.a.N.V. Solovyev | Yaroslavl | 150003 | Russia |
| Municipal Autonomous Institution (City ClinicalHospital #14) | Yekaterinburg | 620039 | Russia |
| Ferguson GT, Kerwin EM, Donohue JF, Ganapathy V, Tosiello RL, Bollu VK, Rajagopalan K. Health-Related Quality of Life Improvements in Moderate to Very Severe Chronic Obstructive Pulmonary Disease Patients on Nebulized Glycopyrrolate: Evidence from the GOLDEN Studies. Chronic Obstr Pulm Dis. 2018 Jun 6;5(3):193-207. doi: 10.15326/jcopdf.5.3.2017.0178. |
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler |
| COMPLETED |
|
| NOT COMPLETED |
|
|
As noted in the participant flow section, one subject withdrew at randomization due to a pre-treatment event prior to being dosed bringing the population total to 1086 from 1087.
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| ID | Title | Description |
|---|---|---|
| BG000 | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer |
| BG001 | Spiriva 18 mcg QD Handihaler | Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||||
| cardiovascular risk (low/high) and categories for high cardiovascular risk | Count of Participants | Participants | No |
| |||||||||||||||||
| background long-acting beta (2) agonist (LABA) use | Count of Participants | Participants | No |
| |||||||||||||||||
| Forced expiratory volume in one second (FEV1) | Mean | Standard Deviation | liters |
|
| 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 | Number of Subjects With Treatment-emergent Adverse Events (TEAE) | A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date. | Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. | Posted | Number | participants | Up to Week 48 |
|
|
| |||||||||||||||||||||||||||||
| Primary | Percentage of Subjects With Treatment-emergent Adverse Events | A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date. | Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. | Posted | Number | percentage of participants | Up to Week 48 |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Treatment-emergent Serious Adverse Events (SAE) | A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date. | Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. | Posted | Number | participants | Up to Week 48 |
|
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Subjects With Treatment-emergent Serious Adverse | A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date. | Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. | Posted | Number | percentage of participants | Up to Week 48 |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Subjects Who Discontinue the Study Due to TEAE | A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date. | Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. | Posted | Number | participants | Up to Week 48 |
|
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Subjects Who Discontinue the Study Due to TEAE | A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date. | Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. | Posted | Number | percentage of participants | Up to 48 Weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke | All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact. | Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. | Posted | Number | participants | Up to Week 48 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke | All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact. | Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. | Posted | Number | percentage of participants | Up to 48 Weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke | All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact. | Incidence rate: TT= Total Time in years. Total Time (TT) is defined as the time from the first date of study drug until the latter of the date of last contact or 30 days after the date of last dose. Incidence Rate (per 1000 person-years) = n/TT x 1000. | Posted | Number | event per 1000 person years | up to week 48 |
| |||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline Over 48 Weeks in Trough FEV1 for All Subjects | Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the FEV1 values collected at the end of the dosing interval at each clinic visit. The mean change from baseline in trough FEV1 over the 48 week treatment period is calculated by averaging the trough FEV1 changes from baseline across all study visits while subjects are taking randomized treatment. Values affected by other medication use were to be set to missing. | Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | liters | Up to Week 48 |
|
up to week 48
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer | 3 | 620 | 76 | 620 | 195 | 620 |
| EG001 | Spiriva 18 mcg QD Handihaler | Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler | 4 | 466 | 49 | 466 | 133 | 466 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute myocardial infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| angina pectoris | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| atrial fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| arterial flutter | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| cardiac failure congestive | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| cardio respiratory arrest | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| coronary artery disease | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| myocardial infraction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| verntricular arrhythmia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| diplopia | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| colitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| duodenal ulcer, obstructive | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| gastric ulcer perforation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| gastrointestinal perforation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| haematochezia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| large intestinal obstruction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| pancreatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| rectal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| small intestinal obstruction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| chest pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| generalized oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| non-cardiac chest pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| cholecystitis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| cholecystitis acute | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| choleithiasis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| abdominal infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| appendicitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| bronchitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| gastronenteritis viral | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| osteomyelitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| pheumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| septic shock | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| systemic candida | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| urosepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| accidental overdose | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| ankle fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| hip fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| impacted fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| joint injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| pubis fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| road traffic accident | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| malnutrition | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| joint effsion | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| carcinoid tumor of the apendix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| non-hodgkins lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| pancreatic crcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| hashimoto's encephalopathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| lumbar radiculopathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| multile sclerosis relapse | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| serotonin syndrome | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| syncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| transient ischaemic attack | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| anxiety | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| suicidal ideation | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| renal failure | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| renal mass | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| urinary retention | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| angioedema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| aortic aneurysm | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| arterios clerosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| pluritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
In the event the Study is part of a multi-center study , the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Respiratory Medical Director | Sunovion Pharmaceuticals Inc. | 1-866-503-6351 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| D006024 | Glycopyrrolate |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Czechia |
|
| Hungary |
|
| United States |
|
| high cardiovascular risk |
|
| ischemic heart disease |
|
| cerebrovascular disease |
|
| periheral arterial disease |
|
| clinically significant arrhythmia |
|
| heart failure |
|
| hyertension |
|
| background LABA use -no |
|
|
|
|
|
|
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|---|---|
| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|