Clinical Studies Unit
The Clinical Studies Unit provides facilities for Pulmonary, Critical Care, Sleep & Allergy Medicine Section faculty interested in clinical research in asthma, bronchitis, emphysema, and smoking cessation. Medications studied have already been through a series of studies and have been shown to be generally safe. Clinical Studies Unit researchers conduct the final stage of research on medications prior to approval by the FDA (Food and Drug Administration).
SMOKING STUDIES:
Smoking Cessation Study:
Principal Investigator: Stephen Rennard, MD
Study Coordinator: Sandy Talbott, MS
402-559-6365
stalbott@unmc.edu
IRB #189-08
Efficacy of Varenicline in Ambivalent Smokers
The purpose of this study is to investigate whether taking varenicline, a medication that blocks the effect of nicotine and makes cigarettes less pleasing, can help smokers reduce and later quit smoking. Varenicline is a nicotine-like prescription medication that is approved by the Food and Drug Administration to help smokers who are actively trying to stop smoking. Varenicline has not been used before to help smokers reduce. We are trying to determine if varenicline can help smokers reduce and help to decide to quit because it blocks the effects of nicotine and thus makes cigarettes less addictive. Approximately 110 subjects will take part in this study at UNMC. The study lasts a total of 6 months and consists of 4 office visits and 4 phone calls.
- 19 years or older
- Current smoker, smoking at least 8 cigarettes per day
- Have never used Chantix
COPD STUDIES:
COPD Study
Principal Investigator: Stephen Rennard, M.D.
Study Coordinator: Molly Deacon, BSN
402-559-8292
mdeacon@unmc.edu
IRB #110-08
A 24-week, Randomized, Double-Blind, Placebo-Controlled, Multicenter study to evaluate the efficacy and safety of 18 mcg of tiotropium inhalation capsules administered by handihaler once-daily plus prn albuterol (Salbutamol) vs placebo plus prn albuterol (Salbutamol) in chronic obstructive pulmonary disease subjects naïve to maintenance therapy
The purpose of this study is to explore the effectiveness and safety of tiotropium (Spiriva) in subjects with mild to moderate COPD. The effect of tiotropium on breathing capacity will be evaluated. (All study drugs used in this study are FDA approved.) The study will also assess whether tiotropium will have an effect on physical activity, symptoms and productivity. There will be about 435 people in this study. Eighteen subjects will be enrolled at UNMC. The study lasts about 28 weeks and consists of 9 office visits.
- 40 – 80 years of age
- Smoker or non-smoker
- Shortness of breath or have been diagnosed with COPD
COPD Study
Principal Investigator: Stephen Rennard, M.D.
Study Coordinator: Lisa Graff, PA-C
402-559-8915
lgraff@unmc.edu
IRB #155-08
A Phase 2A, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation study to evaluate the safety and efficacy of BIO-11006 inhalation solution in subjects with chronic obstructive pulmonary disease
The purpose of this clinical study is to determine whether the study drug is safe and effective in controlling chronic bronchitis caused by inflammation. The study drug, BIO-11006, is an experimental drug that has not been approved for marketing by the United States Food and Drug Administration (FDA). One of two sub-studies of this research investigates how study drug is absorbed, metabolized and eliminated in patients with chronic obstructive pulmonary disease (COPD) and will require blood draws. The sputum collection sub-study investigates the effect of the study drug on airway inflammation in patients with COPD. This is assessed based on tests performed on sputum (mucus) samples. You will be one of approximately 162 subjects taking part in this study at approximately ten study sites throughout the United States. Twenty subjects will be enrolled at UNMC. Your participation in this study will last for approximately 7 to 10 weeks consisting of 9 study visits.
- 45 years of age or older
- Ex-smoker having moderate-to-severe smoking related COPD
COPD Study
Principal Investigator: Stephen Rennard, M.D.
Study Coordinator: Jim Melson, RN, BSN
402-559-8592
jmelson@unmc.edu
IRB #406-05
Evaluation of Airway Gene Expression in COPD and Controlled Populations
The purpose of this study will investigate if there are any proteins or other substances found in the lower airway that may indicate ways to treat COPD or serve as biomarkers of this disease. This study involves a bronchoscopy and consists of 4 office visits. All the visits will be within 8 weeks of each other.
- 45 - 70 years of age
- 10 pack year smoking history and diagnosed with COPD or 10 pack year
smoking history and no COPD or never smoked or less than 1 pack year
smoking history
- Have no major illnesses except COPD
COPD Study
Principal Investigator: Stephen Rennard, M.D.
Study Coordinator: Mary Carlson, MSN, APRN
402-559-6726
mlcarlson@unmc.edu
IRB #027-07
A Randomized, Double-Blind, Placebo controlled, exploratory study to assess the safety and efficacy of multiple doses of ACZ885 in COPD patients
The purpose of this study is to compare 13 intravenous (i.v., directly into the vein) infusions of ACZ885 with matching placebo (no active ingredient) in COPD patients. The study will examine both the safety and effectiveness of AZC885 which is an investigational drug approved for use in clinical studies, but not approved for marketing, by the FDA. There will be 21 visits over approximately a 67 week period. The infusions will take place between visits 5 and 18.
- 20 pack year smoking history and diagnosed with COPD
- 40 - 80 years of age
- Ex-smoker having moderate to severe smoking related COPD
COPD Study
Principal Investigator: Stephen Rennard, M.D.
Study Coordinator: Mary Carlson, MSN, APRN
402-559-6726
mlcarlson@unmc.edu
IRB # IRB # 459-07
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-week clinical study to assess the effect of inhaled aclidinium bromide (LAS34273) 200ug on exercise endurance and lung hyperinflation in patients with moderate to severe chronic obstructive pulmonary disease (COPD)
The purpose of this Phase III study is to further evaluate the effectiveness and safety of LAS34273, also known as aclidinium bromide (an investigational drug approved for use in clinical studies, but not for marketing, by the FDA) for treatment of moderate to severe COPD. The study will examine the effect of aclidinium bromide on how long you can exercise and in reducing hyperinflation of the lung at rest and during exercise. Hyperinflation is caused by over-inflating the lung with air. The study medication will be compared to placebo. This research study will involve around 300 patients in different medical clinics in the United States and Canada. You will be one of 10 patients enrolled at this site. The study will last for approximately nine weeks.
- 40 years of age or older
- Current or ex-smoker with at least a 10 pack year history of smoking
- Have a diagnosis of moderate to severe COPD
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