A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Registration Number
- NCT02276222
- Lead Sponsor
- Sunovion Respiratory Development Inc.
- Brief Summary
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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1087
- Male or female patients age ≥ 40 years, inclusive.
- A clinical diagnosis of COPD according to the GOLD 2014 guidelines.
- Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
- Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 < 80% of predicted normal and > 0.7 L during Screening (Visit 1).
- Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio < 0.70 during Screening (Visit 1).
- Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).
- Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at Visit 1. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: a) an oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following participation; b) barrier method of contraception, e.g., condom and /or diaphragm with spermicide while participating in the study; and/or c) abstinence..
- Willing and able to provide written informed consent.
- Willing and able to attend all study visits and adhere to all study assessments and procedures.
- Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject.
- Concomitant clinically significant respiratory disease other than COPD (eg, asthma, tuberculosis, bronchiectasis or other non-specific pulmonary disease).
- Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening (Visit 1).
- Use of daily oxygen therapy > 12 hours per day.
- Respiratory tract infection within 6 weeks prior to Screening (Visit 1).
- Use of systemic steroids within 3 months prior to Screening (Visit 1).
- History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin.
- Prolonged QTc (> 450 msec for males and > 470 msec for females) during Screening (Visit 1), or history of long QT syndrome.
- History of or clinically significant ongoing bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within the previous 6 months.
- History of narrow angle glaucoma.
- History of hypersensitivity or intolerance to aerosol medications.
- Recent documented history (within the previous 3 months) of substance abuse.
- Significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator.
- Participation in another investigational drug study where drug was received within 30 days prior to Screening (Visit 1) or current participation in another investigational drug trial, including a SUN-101 study.
- Previously received SUN-101 (active treatment; formerly known as EP-101).
- Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, beta2 agonists, or sympathomimetic amines.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SUN-101 50 mcg BID eFlow (CS) nebulizer SUN-101 50 mcg BID eFlow (CS) nebulizer SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer Spiriva 18 mcg QD Handihaler Spiriva® 18 mcg QD Handihaler Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
- Primary Outcome Measures
Name Time Method Number of Subjects With Treatment-emergent Adverse Events (TEAE) Up to Week 48 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.
Percentage of Subjects With Treatment-emergent Adverse Events Up to Week 48 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.
Number of Subjects With Treatment-emergent Serious Adverse Events (SAE) Up to Week 48 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.
Percentage of Subjects With Treatment-emergent Serious Adverse Up to Week 48 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.
Number of Subjects Who Discontinue the Study Due to TEAE Up to Week 48 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.
Percentage of Subjects Who Discontinue the Study Due to TEAE Up to 48 Weeks 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.
- Secondary Outcome Measures
Name Time Method Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke Up to Week 48 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.
Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke Up to 48 Weeks 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 Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke up to week 48 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.
Mean Change From Baseline Over 48 Weeks in Trough FEV1 for All Subjects Up to Week 48 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.
Trial Locations
- Locations (115)
Integrated Research Group, Inc
🇺🇸Riverside, California, United States
Clinical Research Institute of Southern Oregon, PC
🇺🇸Medford, Oregon, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Howard County Center for Lung and Sleep Medicine, LLC
🇺🇸Columbia, Maryland, United States
Southern California Institute For Respiratory Diseases, Inc.
🇺🇸Los Angeles, California, United States
Easley Clinical Research
🇺🇸Easley, South Carolina, United States
Palmetto Medical Research Associates
🇺🇸Easley, South Carolina, United States
AppleMed Research, Inc
🇺🇸Miami, Florida, United States
Research Institute of South Florida, Inc
🇺🇸Miami, Florida, United States
Clinical Trials of Florida, LLC
🇺🇸Miami, Florida, United States
Clinical Research Advantage Inc
🇺🇸Las Vegas, Nevada, United States
Clinical Research Institute, Inc.
🇺🇸Minneapolis, Minnesota, United States
Alamo Clinical Research Associates
🇺🇸San Antonio, Texas, United States
Non-State Private Institution of Healthcare <Scientific Clinical Center>
🇷🇺Moscow, Russian Federation
SB1 of Healthcare of Novosibirsk region <Novosibirsk State Regional Clinical Hospital>l
🇷🇺Novosibirsk, Russian Federation
Hrudnf ambulance s.r.o.
🇨🇿Zatec, Czechia
MediTrial, s.r.o Internf a pneumoloqicka ambulance
🇨🇿Jindřichův Hradec, Czechia
SEC Lung LLC
🇺🇸Andalusia, Alabama, United States
Waterbury Pulmonary Associates, LLC
🇺🇸Waterbury, Connecticut, United States
The Community Research of South Florida
🇺🇸Hialeah, Florida, United States
Avail Clinical Research, llC
🇺🇸DeLand, Florida, United States
Tampa Bay Clinical Research Center
🇺🇸Brandon, Florida, United States
Sunstone Medical Research, L.LC
🇺🇸Medford, Oregon, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Midwest Clinical Research LLC
🇺🇸Saint Louis, Missouri, United States
Somnos Laboratories, Inc d/b/a Somnos Clinical Research
🇺🇸Lincoln, Nebraska, United States
Pioneer Research Solutions, Inc
🇺🇸Houston, Texas, United States
SBI of Healthcare of Nizhny-Novgorod region
🇷🇺Nizhny-Novgorod, Russian Federation
Lillestol Research, LLC
🇺🇸Fargo, North Dakota, United States
Remington Davis Inc
🇺🇸Columbus, Ohio, United States
IVA Researcb
🇺🇸Cincinnati, Ohio, United States
Pulmonary and Allergy Associates, PA
🇺🇸Summit, New Jersey, United States
Hope Clinical Research
🇺🇸Seneca, South Carolina, United States
Greenville Pharmaceutical Research, Inc.
🇺🇸Greenville, South Carolina, United States
Selye Janos Korhaz es Rendelointezet, Tud6gy6gyaszati Szakrendeles
🇭🇺Komárom, Hungary
Si6fok Kornaz-Rendelointezet, Tudoqondozo
🇭🇺Siofok, Hungary
Farmakontroll Egeszsegugyi Szolqaltato Bt
🇭🇺Szazhalombatta, Hungary
Alliance Biomedical, Russian Group LLC
🇷🇺St. Petersburg, Russian Federation
FSBI
🇷🇺Moscow, Russian Federation
SBEI of HPE <North-West State Medical University n.a. LL Mechnikov>
🇷🇺Saint-Petersburg, Russian Federation
Csornai Margit Korhaz, TOd6gy6gyaszat
🇭🇺Csorna, Hungary
Kenezy Gyula Korhaz es Rendelomtezet, Klinikai Farmakologiai
🇭🇺Debrecen, Hungary
Szakorvosi Rendelointezet Monor, Tudoqondozo
🇭🇺Monor, Hungary
Revamed Eqeszsequqyi Szolqaltato Kft.
🇭🇺Nyiregyhaza, Hungary
Csonqrad Megyei Mellkasi Beteqseqek Szakkorhaza, Tudoqondozo lntezet
🇭🇺Szeged, Hungary
SBI of Healthcare Regional Clinical Hospital #4 City consultative department for pulmonological patientsr
🇷🇺Chelyabinsk, Russian Federation
Territorial SBI of Healthcare <Territorial Clinical Hospital>
🇷🇺Barnaul, Russian Federation
Municipal Autonomous Institution (City ClinicalHospital #14)
🇷🇺Ekaterinburg, Russian Federation
SBr of Helathcareof Yaraslavl region Clinical Hospital of Emervency care n.a.N.V. Solovyev
🇷🇺Yaroslavl, Russian Federation
Pulmonary Consultants PLLC
🇺🇸Tacoma, Washington, United States
New Phase Clinical Research & Development
🇺🇸Knoxville, Tennessee, United States
Upstate Pharmaceutical Research, Inc.
🇺🇸Greenville, South Carolina, United States
Delaware Valley Clinical Research, LLC
🇺🇸Marlton, New Jersey, United States
FSSI Scientific Research Institute of Complex Cardiovascular Pathology
🇷🇺Kemerovo, Russian Federation
American Health Research, Inc.
🇺🇸Charlotte, North Carolina, United States
Municipal Budget Institution of Healthcare (City Clinical Hospital #3 n.a. M.A. Podgorbunsky)
🇷🇺Kemerovo, Russian Federation
SBI of Healthcare of Novosibirsk region <Novosibirsk State Regional Clinical Hospital>
🇷🇺Novosibirsk, Russian Federation
Jasper Summit Research LLC
🇺🇸Jasper, Alabama, United States
Clinical Research Advantage, Inc.lEast Valley Family Physicians, PLC
🇺🇸Chandler, Arizona, United States
Desert Sun Clinical Research LLC
🇺🇸Tucson, Arizona, United States
Allianz Research Institute, Inc.
🇺🇸Fountain Valley, California, United States
California Research Medical Group, lnc.
🇺🇸Fullerton, California, United States
Research Center of Fresno, Inc.
🇺🇸Fresno, California, United States
Institute of Healthcare Assessments Inc.
🇺🇸San Diego, California, United States
Ribo Research, LLC dba Peninsula Research, Inc.
🇺🇸Ormond Beach, Florida, United States
Vero Lung Center
🇺🇸Vero Beach, Florida, United States
Gwinnett Biomedical Research
🇺🇸Lawrenceville, Georgia, United States
Evanston Premier Healthcare Research LLC
🇺🇸Evanston, Illinois, United States
Asthma and Allergy Center of Chicago SC
🇺🇸River Forest, Illinois, United States
H.C. Research LLC
🇺🇸Coeur d'Alene, Idaho, United States
LaPorte County Institute For Clinical Research
🇺🇸Michigan City, Indiana, United States
Bendel Medical Research Center, LLC
🇺🇸Lafayette, Louisiana, United States
Buynak Clinical Research, P.C.
🇺🇸Valparaiso, Indiana, United States
Kentucky Lung Clinics, PSC
🇺🇸Hazard, Kentucky, United States
Minnesota Lung Center
🇺🇸Woodbury, Minnesota, United States
Pulmonary Research Institute of Southeast Michigan
🇺🇸Livonia, Michigan, United States
Midwest Chest Consultants PC
🇺🇸Saint Charles, Missouri, United States
Abraham Research, PLLC
🇺🇸Fort Mitchell, Kentucky, United States
Pulmonary and Critical Care Associates of Baltimore
🇺🇸Towson, Maryland, United States
Cadillac Clinical Research LLC
🇺🇸Cadillac, Michigan, United States
CARE Clinical Research
🇺🇸Saint Louis, Missouri, United States
The Clinical Research Center
🇺🇸Saint Louis, Missouri, United States
ISA Clinical Research
🇺🇸Jamaica, New York, United States
Atlantic Research Center, LLC
🇺🇸Ocean City, New Jersey, United States
ARSM Research
🇺🇸Huntersville, North Carolina, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
Clinical Research of Lake Norman
🇺🇸Huntersville, North Carolina, United States
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
Spectrum Medical Research, LLC
🇺🇸Gaffney, South Carolina, United States
Gaffney Pharmaceutical Research
🇺🇸Gaffney, South Carolina, United States
DeGarmo Institute of Medical Research
🇺🇸Greer, South Carolina, United States
Clinical Research of Charleston
🇺🇸Mount Pleasant, South Carolina, United States
S. Carolina Pharmaceutical Research
🇺🇸Spartanburg, South Carolina, United States
CU Pharmaceutical Research
🇺🇸Union, South Carolina, United States
Corsicana Medical Research, PLLC
🇺🇸Corsicana, Texas, United States
Medicentrum Beroun s.r o.
🇨🇿Beroun, Czechia
Nemocnice Kyjov, p.o.
🇨🇿Kyjov, Czechia
Plicni ambulance
🇨🇿Neratovice, Czechia
MephaCentrum, a s Plicni oddeleni
🇨🇿Ostrava - Poruba, Czechia
MephaCentrum, a.s.
🇨🇿Ostrava-Poruba, Czechia
PLiCNI AMBULANCE ROKYCANY, s.r o.
🇨🇿Rokycany, Czechia
PNEUMa-HOST s LO.
🇨🇿Praha, Czechia
Dr. Kenessey Albert Korhaz-Rendetointezet, TOd6gy6gyaszati
🇭🇺Balassagyarmat, Hungary
Lumniczer Sandor Korhaz as Rendelointezet, Tudoqondozo
🇭🇺Kapuvar, Hungary
Veszprern Megyei Tudbgyogyintezet
🇭🇺Farkasgyepű, Hungary
Somogy Megyei Kaposi M6r Oktat6 Korhaz, Tudoqondozo
🇭🇺Kaposvar, Hungary
FSBI Far Eastern Research Centre ofPhysiology and Pathology of Breathing of Siberian branch of RAMS
🇷🇺Blagoveshchensk, Russian Federation
Achieve Clinical Research LLC
🇺🇸Birmingham, Alabama, United States
New Orleans Center for Clinical Research
🇺🇸New Orleans, Louisiana, United States
Clinical Research of West Florida
🇺🇸Tampa, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Florida Institute For Clinical Research, LLC
🇺🇸Orlando, Florida, United States
Southeastern Research Center
🇺🇸Winston-Salem, North Carolina, United States
Allergy Associates Research Center
🇺🇸Portland, Oregon, United States
Lowcountry Lung and Critical Care, PA
🇺🇸Charleston, South Carolina, United States