A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-5)

A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter, Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD: GOLDEN-5 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)

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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: SUN-101 50 mcg BID eFlow (CS) nebulizer; Drug: Spiriva® 18 mcg QD Handihaler

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).

• Study Type: Interventional
• Enrollment (Actual): 1087
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Beroun, Czechia, 266 01
    • Medicentrum Beroun s.r o.
  • Jindřichův Hradec, Czechia, 377 01
    • MediTrial, s.r.o Internf a pneumoloqicka ambulance
  • Kyjov, Czechia, 69733
    • Nemocnice Kyjov, p.o.
  • Neratovice, Czechia, 277 11
    • Plicni ambulance
  • Ostrava - Poruba, Czechia, 708 00
    • MephaCentrum, a s Plicni oddeleni
  • Ostrava-Poruba, Czechia, 708 00
    • MephaCentrum, a.s.
  • Praha, Czechia, 158 00
    • PNEUMa-HOST s LO.
  • Rokycany, Czechia, 337 01
    • PLiCNI AMBULANCE ROKYCANY, s.r o.
  • Zatec, Czechia, 438 01
    • Hrudnf ambulance s.r.o.
• Hungary
  • Balassagyarmat, Hungary, H-2660
    • Dr. Kenessey Albert Korhaz-Rendetointezet, TOd6gy6gyaszati
  • Csorna, Hungary, H-9300
    • Csornai Margit Korhaz, TOd6gy6gyaszat
  • Debrecen, Hungary, H-4043
    • Kenezy Gyula Korhaz es Rendelomtezet, Klinikai Farmakologiai
  • Farkasgyepű, Hungary, H-8582
    • Veszprern Megyei Tudbgyogyintezet
  • Kaposvar, Hungary, H-7400
    • Somogy Megyei Kaposi M6r Oktat6 Korhaz, Tudoqondozo
  • Kapuvar, Hungary, H-9330
    • Lumniczer Sandor Korhaz as Rendelointezet, Tudoqondozo
  • Komárom, Hungary, H-2900
    • Selye Janos Korhaz es Rendelointezet, Tud6gy6gyaszati Szakrendeles
  • Monor, Hungary, H-2200
    • Szakorvosi Rendelointezet Monor, Tudoqondozo
  • Nyiregyhaza, Hungary, H-4400
    • Revamed Eqeszsequqyi Szolqaltato Kft.
  • Siofok, Hungary, H-8600
    • Si6fok Kornaz-Rendelointezet, Tudoqondozo
  • Szazhalombatta, Hungary, H-2440
    • Farmakontroll Egeszsegugyi Szolqaltato Bt
  • Szeged, Hungary, H-6722
    • Csonqrad Megyei Mellkasi Beteqseqek Szakkorhaza, Tudoqondozo lntezet
• Russian Federation
  • Barnaul, Russian Federation, 656024
    • Territorial SBI of Healthcare <Territorial Clinical Hospital>
  • Blagoveshchensk, Russian Federation, 675000
    • FSBI Far Eastern Research Centre ofPhysiology and Pathology of Breathing of Siberian branch of RAMS
  • Chelyabinsk, Russian Federation, 454021
    • SBI of Healthcare Regional Clinical Hospital #4 City consultative department for pulmonological patientsr
  • Ekaterinburg, Russian Federation, 620039
    • Municipal Autonomous Institution (City ClinicalHospital #14)
  • Kemerovo, Russian Federation, 650000,
    • Municipal Budget Institution of Healthcare (City Clinical Hospital #3 n.a. M.A. Podgorbunsky)
  • Kemerovo, Russian Federation, 650002
    • FSSI Scientific Research Institute of Complex Cardiovascular Pathology
  • Moscow, Russian Federation, 115682
    • FSBI
  • Moscow, Russian Federation, 125315
    • Non-State Private Institution of Healthcare <Scientific Clinical Center>
  • Nizhny-Novgorod, Russian Federation, 603126
    • SBI of Healthcare of Nizhny-Novgorod region
  • Novosibirsk, Russian Federation, 630087
    • SB1 of Healthcare of Novosibirsk region <Novosibirsk State Regional Clinical Hospital>l
  • Novosibirsk, Russian Federation, 630087
    • SBI of Healthcare of Novosibirsk region <Novosibirsk State Regional Clinical Hospital>
  • Saint-Petersburg, Russian Federation, 195067
    • SBEI of HPE <North-West State Medical University n.a. LL Mechnikov>
  • St. Petersburg, Russian Federation, 194358
    • Alliance Biomedical, Russian Group LLC
  • Yaroslavl, Russian Federation, 150003
    • SBr of Helathcareof Yaraslavl region Clinical Hospital of Emervency care n.a.N.V. Solovyev
• United States
  • Alabama
    • Andalusia, Alabama, United States, 36420
      • SEC Lung LLC
    • Birmingham, Alabama, United States, 35216
      • Achieve Clinical Research LLC
    • Jasper, Alabama, United States, 35501
      • Jasper Summit Research LLC
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Clinical Research Advantage, Inc.lEast Valley Family Physicians, PLC
    • Tucson, Arizona, United States, 85710
      • Desert Sun Clinical Research LLC
  • California
    • Fountain Valley, California, United States, 92708
      • Allianz Research Institute, Inc.
    • Fresno, California, United States, 93702
      • Research Center of Fresno, Inc.
    • Fullerton, California, United States, 92835
      • California Research Medical Group, lnc.
    • Los Angeles, California, United States, 90048
      • Southern California Institute For Respiratory Diseases, Inc.
    • Riverside, California, United States, 92506
      • Integrated Research Group, Inc
    • San Diego, California, United States, 92120
      • Institute of Healthcare Assessments Inc.
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Waterbury Pulmonary Associates, LLC
  • Florida
    • Brandon, Florida, United States, 33511
      • Tampa Bay Clinical Research Center
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Hialeah, Florida, United States, 33016
      • The Community Research of South Florida
    • Miami, Florida, United States, 33186
      • Clinical Trials of Florida, LLC
    • Miami, Florida, United States, 33155
      • AppleMed Research, Inc
    • Miami, Florida, United States, 33173
      • Research Institute of South Florida, Inc
    • Orlando, Florida, United States, 32825
      • Florida Institute for Clinical Research, LLC
    • Ormond Beach, Florida, United States, 32174
      • Ribo Research, LLC dba Peninsula Research, Inc.
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida, Inc.
    • Vero Beach, Florida, United States, 32960
      • Vero Lung Center
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • Gwinnett Biomedical Research
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • H.C. Research LLC
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Evanston Premier Healthcare Research LLC
    • River Forest, Illinois, United States, 60305
      • Asthma and Allergy Center of Chicago SC
  • Indiana
    • Michigan City, Indiana, United States, 46360
      • LaPorte County Institute for Clinical Research
    • Valparaiso, Indiana, United States, 46383
      • Buynak Clinical Research, P.C.
  • Kentucky
    • Fort Mitchell, Kentucky, United States, 41017
      • Abraham Research, PLLC
    • Hazard, Kentucky, United States, 41701
      • Kentucky Lung Clinics, PSC
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Bendel Medical Research Center, LLC
    • New Orleans, Louisiana, United States, 70119
      • New Orleans Center for Clinical Research
  • Maryland
    • Columbia, Maryland, United States, 21044
      • Howard County Center for Lung and Sleep Medicine, LLC
    • Towson, Maryland, United States, 21204
      • Pulmonary and Critical Care Associates of Baltimore
  • Michigan
    • Cadillac, Michigan, United States, 49601
      • Cadillac Clinical Research LLC
    • Livonia, Michigan, United States, 48152
      • Pulmonary Research Institute of Southeast Michigan
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Minnesota Lung Center
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute, Inc.
    • Minneapolis, Minnesota, United States, 55407
      • Minnesota Lung Center
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Lung Center
  • Missouri
    • Saint Charles, Missouri, United States, 63301
      • Midwest Chest Consultants PC
    • Saint Louis, Missouri, United States, 63141
      • The Clinical Research Center
    • Saint Louis, Missouri, United States, 63141
      • Midwest Clinical Research LLC
    • Saint Louis, Missouri, United States, 63141
      • CARE Clinical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Somnos Laboratories, Inc d/b/a Somnos Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Clinical Research Advantage Inc
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Delaware Valley Clinical Research, LLC
    • Ocean City, New Jersey, United States, 07712
      • Atlantic Research Center, LLC
    • Summit, New Jersey, United States, 07901
      • Pulmonary and Allergy Associates, PA
  • New York
    • Jamaica, New York, United States, 11435
      • ISA Clinical Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • American Health Research, Inc.
    • Huntersville, North Carolina, United States, 28078
      • ARSM Research
    • Huntersville, North Carolina, United States, 28078
      • Clinical Research of Lake Norman
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Lillestol Research, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • IVA Researcb
    • Columbus, Ohio, United States, 43215
      • Remington Davis Inc
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
  • Oregon
    • Medford, Oregon, United States, 97504
      • Clinical Research Institute of Southern Oregon, PC
    • Medford, Oregon, United States, 97504
      • Sunstone Medical Research, L.LC
    • Portland, Oregon, United States, 97202
      • Allergy Associates Research Center
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Lowcountry Lung and Critical Care, PA
    • Easley, South Carolina, United States, 29640
      • Easley Clinical Research
    • Easley, South Carolina, United States, 29640
      • Palmetto Medical Research Associates
    • Gaffney, South Carolina, United States, 29340
      • Gaffney Pharmaceutical Research
    • Gaffney, South Carolina, United States, 29341
      • Spectrum Medical Research, LLC
    • Greenville, South Carolina, United States, 29615
      • Greenville Pharmaceutical Research, Inc.
    • Greenville, South Carolina, United States, 29615
      • Upstate Pharmaceutical Research, Inc.
    • Greer, South Carolina, United States, 29651
      • DeGarmo Institute of Medical Research
    • Mount Pleasant, South Carolina, United States, 29464
      • Clinical Research of Charleston
    • Seneca, South Carolina, United States, 29678
      • Hope Clinical Research
    • Spartanburg, South Carolina, United States, 29303
      • S. Carolina Pharmaceutical Research
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
    • Union, South Carolina, United States, 29379
      • CU Pharmaceutical Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37919
      • New Phase Clinical Research & Development
  • Texas
    • Corsicana, Texas, United States, 75110
      • Corsicana Medical Research, PLLC
    • Houston, Texas, United States, 77099
      • Pioneer Research Solutions, Inc
    • San Antonio, Texas, United States, 78212
      • Alamo Clinical Research Associates
  • Washington
    • Tacoma, Washington, United States, 98405
      • Pulmonary Consultants PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patients age ≥ 40 years, inclusive.
2. A clinical diagnosis of COPD according to the GOLD 2014 guidelines.
3. Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
4. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 < 80% of predicted normal and > 0.7 L during Screening (Visit 1).
5. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio < 0.70 during Screening (Visit 1).
6. Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).
7. 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..
8. Willing and able to provide written informed consent.
9. Willing and able to attend all study visits and adhere to all study assessments and procedures.

Exclusion Criteria:

1. 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.
2. Concomitant clinically significant respiratory disease other than COPD (eg, asthma, tuberculosis, bronchiectasis or other non-specific pulmonary disease).
3. Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening (Visit 1).
4. Use of daily oxygen therapy > 12 hours per day.
5. Respiratory tract infection within 6 weeks prior to Screening (Visit 1).
6. Use of systemic steroids within 3 months prior to Screening (Visit 1).
7. 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.
8. Prolonged QTc (> 450 msec for males and > 470 msec for females) during Screening (Visit 1), or history of long QT syndrome.
9. History of or clinically significant ongoing bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within the previous 6 months.
10. History of narrow angle glaucoma.
11. History of hypersensitivity or intolerance to aerosol medications.
12. Recent documented history (within the previous 3 months) of substance abuse.
13. Significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator.
14. 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.
15. Previously received SUN-101 (active treatment; formerly known as EP-101).
16. Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, beta2 agonists, or sympathomimetic amines.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SUN-101 50 mcg BID eFlow (CS) nebulizer; SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer	Drug: SUN-101 50 mcg BID eFlow (CS) nebulizer; SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer; Other Names: Glycopyrrolate
Active Comparator: Spiriva 18 mcg QD Handihaler; Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler	Drug: Spiriva® 18 mcg QD Handihaler; Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler; Other Names: (tiotropium)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Sunovion Respiratory Development Inc.
• Investigators: Study Director: Respiratory Medical Director, Sunovion Respiratory Development

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 27, 2014
• First Posted (Estimate): October 28, 2014

Study Record Updates

• Last Update Posted (Actual): March 13, 2018
• Last Update Submitted That Met QC Criteria: February 13, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Glycopyrrolate; Tiotropium Bromide
• Other Study ID Numbers: SUN101-303