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Clinical Research Studies Introduction
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A major strength of Pulmonary and Critical Care Medicine
at UNC rests in the ability to perform clinical research studies
that bring new understanding to the development of lung diseases,
and test new approaches to the treatment of lung disease. You
will find a listing of current and upcoming studies being performed
at UNC listed below. If you are interested in learning more
about any of these studies or participating in this research,
please feel free to contact us (pulmonary@med.unc.edu).
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Cystic Fibrosis
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Measurement of Airway Transepithelial Electric Potential Difference in Subjects with Cystic Fibrosis. (GCRC 308).
Sponsor: Cystic Fibrosis Foundation
Principal Investigator: Michael R. Knowles, MD.
The purpose of this study is to characterize the clinical presentation of and biological mechanisms associated with lung disease in patients with abnormal ion transport and/or abnormal airway secretions. Patients with CF, Liddle's Disease, PHA, and Idiopathic Chronic Pancreatitis > 18 years of age in stable health are eligible for this study as are healthy volunteers > 18 years of age, without history of pulmonary or atopic disease. |
Blood Collection to Test for Genetic Modifiers in Cystic Fibrosis. (02-MED-119).
Sponsor: Cystic Fibrosis Foundation.
Principal Investigator: Michael R. Knowles, MD.
In this study researchers are interested in studying DNA blood samples from people with CF to determine if other non-CF genes (modifiers) may contribute to CF disease severity or mildness. All CF patients are eligible for this study.
Contact: Kathy Hohneker, RN
Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis (GCRC-1611)
Sponsor: Cystic Fibrosis Foundation
Principal Investigator: Dr. Scott Donaldson
Description: This study is designed to test whether a strategy aimed at increasing the amount of liquid in CF airways improves the clearance of secretions, lung function, and symptoms. Patients with cystic fibrosis who are at least 14 years old with an FEV1 of at least 50% of predicted are eligible for this treatment study. The entire study will be conducted over a 4 week period, and will require several study visits to UNC.
Contact: Dianne Mattingly, RN
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Pulmonary Hypertension |
A1481243: A multinational, multi-center, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to bosentan in the treatment of subjects, aged 18 years and above, with pulmonary arterial hypertension (PAH)
Principal Investigator: Ashley Henderson, MD
Description: Pulmonary Arterial Hypertension (PAH) is a rare blood vessel problem in the lung in which the blood pressure in the pulmonary artery goes above normal levels and may become life threatening. Sildenafil is an approved prescription drug that helps to make narrow blood vessels wider, so that blood can flow to the right places at the right pressure. Bosentan (Tracleer) is a current treatment for PAH patients. This study will enroll subjects who have been diagnosed with PAH and are currently taking bosentan. This study is being conducted to find out if oral sildenafil can help treat chronic PAH when added to the subject's current daily medication. Contact: Joyce Lanier, RRT
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Lung
Transplantation
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None of this time.
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PCD
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Clinical Characteristics of and Identification
of (PCD) Genetic Mutations in Patients with Primary Ciliary
Dyskinesia and Their Family Members. (GCRC 1395)
Sponsor: The National Heart, Lung and Blood Institute.
PI: Michael Knowles, MD.
This purpose of this study is to characterize the clinical presentation
of patients with PCD, and to identify the genetic mutations
associated with PCD. All patients with proven PCD, or those
very likely to have PCD, and their family members will be included.
Normal healthy subjects > 18 years of age as controls will also
be included for nasal nitric oxide studies and nasal lavage.
Contact: Susan Minnix, RN
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ICU
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2001-001 A Phase 4, Randomized, Double-Blind, Multi-Center, Comparator Study Evaluating the Safety and Efficacy of Dexmedetomidine Compared to IV Midazolam in ICU Subjects Requiring Greater than Twenty-Four Hours of Continuous Sedation
Principal Investigator: Shannon Carson, MD
Description:
The purpose of this research study is to learn about dexmedetomidine (Precedex), a sedative drug that is used in intensive care units to treat patients who must use a ventilator to help them breathe. Precedex is an FDA-approved sedative that is used in the intensive care unit to provide sedation for up to 24 hours. The purpose of this Phase IV study is to determine the safety and effectiveness of Precedex when it is used for longer than 24 hours. To determine this, subjects enrolled in the study will be randomized to receive Precedex or midazolam as their sedative, and the two groups of subjects will be compared. Midazolam is also approved by the FDA, and patients who are going to be sedated for more than 24 hours have often received midazolam. Contact: Joyce Lanier, RRT
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Airway
Biology
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Understanding Airway Diseases
The Cystic Fibrosis Research and Treatment Center is conducting several research studies aimed at increasing our understanding of airway diseases such as: cystic fibrosis, chronic bronchitis, and Sjogren's syndrome . These studies may entail nasal studies (e.g. the collection of nasal secretions or a small sample of cells lining the nose), the use of medications in the nose, or bronchoscopy. Normal volunteers and patients with cystic fibrosis, chronic bronchitis, Sjogren's syndrome may participate in these studies. Individual (active and pending) studies are listed below:
· Effects of Topical Application of Drugs on Nasal Epithelial Electrical Potential Difference (81-MED-14)
PI : Michael R. Knowles, MD
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· Pulmonary Epithelia in Health and Disease (00-MED-416)
PI : Drs. R. Boucher/M. Knowles
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COPD/Chronic Bronchitis/Emphysema
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A 52 week, randomized, double-blind, parallel group, placebo controlled, multi-center clinical trial, to assess the efficacy and safety of 200 µg of the anticholinergic LAS 34273 compared to placebo, both administered once-daily by inhalation, in the maintenance treatment of patients with moderate to severe, stable chronic obstructive pulmonary disease. (Protocol #: M/34273/31)
Principal Investigator: James Donohue, MD
Description: The purpose of this research study is to investigate a new anticholinergic drug in the treatment of COPD. COPD medications are used to alleviate shortness of breath and cough, and to treat infections of the lungs that can worsen COPD. The most important medications belong to a class of drugs called bronchodilators. Bronchodilators relax the muscles around the bronchi (tubes in the lungs) to allow easier breathing. There are two main kinds of inhaled bronchodilators. These include “beta-agonists” and “anticholinergics”. Both medications are designed to keep airways open. This new research drug is a long-acting anticholinergic drug that would be taken once a day. It would be taken via an inhaler.
Contact: Joyce Lanier, RRT
Airway Inflammation and Mediators in Chronic Bronchitis (GCRC 969)
Primary Investigator: Dr. Michael Knowles
Description: The goal of the study is to characterize the composition of the airway secretions of subjects with chronic bronchitis during periods of relative clinical stability, and during an exacerbation. We will also study normal volunteers, and patients with Sjogren's Syndrome and post-lung transplantation. This will aid in understanding differences in airway surface liquid milieu between patients with Sjogren's Syndrome and post-lung transplantation, and without lung disease. The goal is to gain insights into the mechanism of pathogenesis in chronic bronchitis, cystic fibrosis, and other lung diseases.
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Pulmonary
Infections
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Study of Genetic Susceptibility to Pulmonary Infection with Nontuberculous Mycobacterium in Individuals without known Immunodeficiency (GCRC 1649)
Principal Investigator: Dr. Michael Knowles
Description: This study is a pilot study to investigate whether there is a higher than expected frequency of CFTR (cystic fibrosis transmembrane conductance regulator) gene mutations in patients who have been diagnosed with nontuberculous mycobacterial pulmonary infection as defined in the American Society Thoracic Society statement, "Diagnosis and Treatment of Disease Caused by Nontuberculous Mycobacteria". The study subjects will have no known immunodeficiency. We anticipate enrolling 100 adults with pulmonary disease with mycobacterium avian complex (MAC). Primary data analysis will evaluate the frequency of CFTR gene mutations in the study population.
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Sarcoidosis |
None of this time.
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Faculty and Staff 
