Clinical Research Programs
Effects of mechanical ventilation:
As members of ARDSNet, Drs. Shanholtz and Silverman are co-authors of the landmark study of low tidal volume in ARDS. They continue to study new treatment modalities to improve outcome in this area.
Acute lung injury is an important problem targeted for joint attack by the Pulmonary and Surgery/Trauma faculty. Together with basic support of our Inflammation Research Group, we have the potential to be at the forefront of elucidating the mechanisms and perfecting therapy of acute lung injury.
Effects of Anti-TNF therapy in COPD:
Chronic obstructive pulmonary disease (COPD) is a devastating clinical problem, growing in importance. In addition to severe problems in lung function, there is evidence that inflammation plays a major role in leading to disability in COPD. Elevation of an inflammatory factor in COPD, tumor necrosis factor alpha (TNF?), could cause severe weight loss, muscle weakness and wasting. These findings are a grave sign in COPD patients.
Drs. Scharf and Hasday is conducting a pilot study on COPD patients using the anti-TNF-A antibody infliximab. A number of outcomes are being studied including lung function, muscle strength, exercise performance, body composition, and quality of life. As well the effects of therapy on serum and sputum cytokines is being evaluated.
Data gathered from this pilot study may be used to design a large randomized clinical trial of a novel new therapy for COPD in a larger group of patients.
Pharmacogenetics of asthma/Corticosteroid resistance:
Dr. Pam Amelung is extending her previous work on the pharmacogenomics of asthma to the molecular basis of corticosteroid resistance in asthmatics. She is studying if alternative splicing of the glucocorticoid receptor so as to increase levels of the inactive form, is associated with clinical corticosteroid resistance in asthma.
Along with identifying the molecular mechanisms for the heterogeneity in leukotriene generation in asthma, this research will put our group in the forefront of the pharmacogenetic analysis of asthma. This work has been incorporated into a clinical proposal to the NIH sponsored COPD Clinical Research Network.
University of Maryland Airway Research Center:
This center (Dr. Amelung, director) is devoted to the clinical study of new
For a complete description of the activities of this center, visit University of Maryland Airway Research Center.
National Emphysema Treatment Trial (NETT):
This is a large-scale NIH-sponsored multisite trial of lung volume reduction surgery for treatment of end-stage emphysema. The University of Maryland is a clinical center of this trial in a consortium with Johns Hopkins University.
In addition, Dr. Scharf, who recently joined the faculty from Albert Einstein College of Medicine, was co-PI of the Columbia-AECOM site in New York and has continued his interest in this trial. He has focused on cardiovascular effects of emphysema and lung reduction surgery and the metabolic/nutritional effects of emphysema.
The trial is in its final stages. The principal outcomes have been studied. Currently long-term follow-up and additional cardiovascular studies are in the final stages of completion.
Mechanisms of Interstitial Lung Disease:
This collaborative study with thoracic surgery, pathology, rheumatology, and radiology is analyzing cutting edge dynamic imaging, histopathology, and molecular and biochemical mediators of inflammation and fibrosis in bronchoalveolar lavage fluid and video-assisted thoracoscopic lung biopsies, to elucidate the biochemical pathways and gene activation pattern associated with usual interstitial pneumonia, and those which are associated with responsiveness to therapy.
Feasibility of Retinoic Acid in the Treatment of Emphysema (FORTE):
This NIH-sponsored trial is a feasibility trial on the use of retinoids for treating moderate to severe emphysema.
Dr. Scharf, who recently joined the faculty from Albert Einstein College of Medicine, was CO-PI of the Columbia-AECOM site in New York and has continued his interest in this trial. He continues as an investigator in the trial, focusing on nutritional metabolic aspects of the trial in collaboration with Dr. J. Ramsdell (UCSD).
COPD Clinical Research Network:
The University of Maryland is a member of the National Institutes of Health-sponsored COPD Clinical Research Network (Dr. Steven M. Scharf, Principal Investigator). This multicenter network is federally funded to develop centers nationwide that perform clinical research on Chronic Obstructive Pulmonary Disease (COPD). The network has completed recruitment for four trials: The AmBox Study, the Macrolide Study, the Pneumonia Vaccine Study, and the Leukotriene Study. We are beginning recruitment for a trial to study the effects of a cholesterol-lowering medication (simvastatin) on the frequency and severity of COPD flare-ups (STATCOPE Study).
In addition to our work with the COPD Clinical Research Network, the University of Maryland also conducts industry-sponsored studies at the University of Maryland Airways Research Center at the University Specialty Hospital. Currently, we are working with pharmaceutical companies like Forrest Laboratories and Glaxo Smith Kline to test new therapies for the treatment of COPD.
Lastly, the COPD Clinical Research Center is participating in a multicenter study to test the effectiveness of oxygen therapy in COPD patients with mild to moderately low levels of oxygen in the blood. These levels would not normally qualify to receive supplemental oxygen. This study is currently recruiting participants.
Click the link below for more information, or contact our research staff at 410-706-3355 or 410-706-LUNG (5864).
COPD Research at the University of Maryland
Dr. Jim Britt has advanced work initiated by Dr. Hasday and Dr. Charles White of the Department of Radiology in which rapid acquisition CT operating in "real-time fluoro-mode," is used to guide transbronchoscopic biopsy of pulmonary and mediastinal lesions.
Dr. Britt is now collaborating with colleagues in Radiation and Medical Oncology in application of the same technologies to target novel therapeutic modalities, including brachytherapy and radiofrequency ablation catheters, within peripheral lung lesions.
Combined Medical-Surgical Critical Care Clinical Research Program:
This joint initiative by the Departments of Medicine and Surgery combines the resources of the institution's medical and surgical intensive care units, including the world renowned Maryland Shock-Trauma Center.
The combination of these resources forms an extensive consortium of patients and clinical investigators to conduct NIH- and industry-sponsored studies and to provide support for new, investigator-initiated research, including projects developed by trainees.