Active Studies
Asthma:
Macrolides in Asthma (MIA): This is a study of the role chronic infection with certain bacteria that may have in asthma. This is a 33 week study.
Best Adjustment Strategy for Asthma over Long Term (BASALT): This study compares the effects of three strategies to adjust inhaled corticosteroids in asthmatics. This study is a total of 44 weeks.
Tiotropium Bromide as an Alternative to increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC): This study compares the use of tiotropium versus increasing the dose of inhaled steroids. This study is 52 week study.
Mycoplasma and Airway Remodeling in Asthma (IRB 6625, NIH sponsored). This is a study to evaluate the effect of Mycoplasma pneumoniae on cellular behavior in chronic asthma in adults. Study involves methacholine challenge, chest x-ray and routine labs.
Airway Remodeling in Asthma: Modulation by Interleukin-13 (IRB 8848, NIH sponsored). This is a study to evaluate whether or not the cytokine interleukin-13 modulates airway fibroblast function in asthma via increased expression of PDGF. Asthmatic patients with a post bronchodilator FEV1>50% and stable symptoms are eligible for study. Subjects are adult asthmatics who are not using inhaled steroids or leukotriene modifiers. Study involves methacholine challenge, chest x-ray, complete pulmonary function testing and routine labs for screening.
GSNO reductase, S-nitrosothiols, and Asthma (GSNO): This study will assess the loss of S-nitrosothiols which are naturally occurring airway dilators in the lungs in asthma. Study involves methacholine challenge, chest x-ray and routine labs for screening.
If you are interested in participating in any of these studies or have any questions please contact our lead study coordinator Denise Beaver by phone at 919 479-0719 or Email denise.beaver@duke.edu
.
The Study of Acid Reflux in Children with Asthma (SARCA): This trial will be similar to SARA above. It will enroll children 6-17 years old who are still having asthma symptoms despite daily use of at least low dose inhaled corticosteroid medicines. The study includes 9 visits over 6 months.
If you are interested in participating in this study or have any questions please contact the study coordinator Ginny Dudek by phone at 919 684-0191 or Email ginny.dudek@duke.edu
.
COPD:
A Randomized, Double-blind Study to Evaluate the Safety and Effectiveness of the Exhale Drug-Eluting Stent in Homogeneous Emphysema Subjects with Severe Hyperinflation (EASE): The Exhale Drug-Eluting Stent is intended for use in the airway bypass procedure to improve the clinical status of emphysema patients with homogeneous disease and severe hyperinflation by increasing pulmonary function and reducing dyspnea through the creation and structural reinforcement of extra-anatomical pathways in the airways.
Metabolomic and Inflammatory Profiling in Patients with COPD: The purpose of this study is to examine systemic changes in metabolism, hormones, and inflammation following standard treatment with combination of salmeterol 50mcg and fluticasone propionate 250 mcg. Study involves chest x-ray, complete pulmonary function testing, and routine labs for screening.
Future Studies:
These trials are not yet open to subject enrollment. They are in the final phases of sponsor and institutional review and approval.
Asthma:
A Randomized, Double-blinded, Placebo controlled, Parallel Group, Multi-Center Study to Assess Safety, Tolerability, Pharmacokineatics, Pharmacodynamics and Efficacy of Intravenous Doses of QAX576 in Moderate Persistent Allergic Asthmatics Following Inhaled Corticosteroid Withdrawal (QAX576): This study will address the effectiveness of QAX576 in allergic moderate persistent asthmatics who are steroid sensitive as evidenced by a drop in peak flow measurements when inhaled corticosteroids are withdrawn. Study is 5-7 months with 3 overnight visits. Study involves complete pulmonary function testing and routine labs for screening.
COPD:
The Long-term Oxygen Therapy Trial (LOTT): This is trial of oxygen therapy sponsored by the National Heart, Lung, and Blood Institute of the NIH. The trial will investigate whether there is a long-term benefit to round-the-clock oxygen therapy in patients with moderately severe COPD and moderately low blood oxygen levels. Further information can be found from the
NIH press release
A Non-Randomized, Early-Phase Study of the Safety and Tolerability and Imaging Feasibility of NC100674 Inhalation in Magnetic Resonance Imaging of the Lungs in Healthy Volunteers and Subjects with Emphysema (XENON): This study will evaluate the potential feasibility of using MRI of the lungs with inhalation of NC100674 to distinguish between subjects with and without emphysema and to evaluate the safety and tolerability of NC100674 when given by multiple-dose, single-breath inhalation at intervals of 15 minutes followed by approximately 15-second breath-holds. Study involves complete pulmonary function testing and routine labs for screening.
COPDGene (Genetic epidemiology of COPD): This study will investigate genes that increase the risk of developing COPD.
Recently Completed Trials
These trials are closed to enrollment.
SARA: Study of Acid Reflux in Asthma. This is a study of anti-acid therapy in adult asthmatics who are not adequately controlled on moderate doses of conventional asthma controller medications.
Anti-IgE Therapy in Children 6-12 Years of Age with Poorly Controlled Asthma. This trial studies the effectiveness and safety of anit-IgE in children who have had moderate to severe asthma symptoms despite moderate to high dose inhaled steroid therapy.
Bronchoplasty in Severe Asthma (AIR2): This study employs radiofrequency heat via bronchoscopy over three visits to decrease symptoms in moderate to severe asthma. Subjects must be taking Advair 500/50 or equivialent and experiences fewer than four asthma flares per year.
The Effect of Roflumilast on Exaerbations in Chronic Obstructive Pulmonary Disease (IRB 8928): This is a study of of the effect/safety/tolerability of roflumilast in patients with COPD ages 40 years or greater.Subjects must have a diagnosis of COPD for at least 12 months as defined by ATS/ERS standards and at least one flare of COPD in the previous 12 months.
COPD –AIM Study (IRB 9267): This is a study to evaluate the effects of fluticasone /salmeterol (250/50) vs. salmeterol on inflammatory markers and clinical endpoints in patients with COPD. Subjects participate for 17-18 weeks and must be > 40 years old with tobacco history of at least 10 years. Formal diagnosis of COPD by ATS/ERS standards s required and FEV1 <70% (pre-bronchodilator) and FEV1/FVC ratio < 70% (post-bronchodilator).
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