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The Outpatient studies we are currently recruiting for are as follows (Spring 2009):
Asthma
Protocol Name: The Study of Acid Reflux in Children with Asthma
Sponsor: ALA- ACRC / NIH
PI: John Mastronarde, MD / Jonathan Parsons, MD
Coordinator: David Cosmar
Synopsis: Study to determine if treating adolescent asthmatics with Prevacid improves asthma control.
Protocol Name: The Asthma Registry for Contact and Possible Participation in a Future Asthma Research Study
Sponsor: Pulmonary Division/ OSU Asthma Center
PI: John Mastronarde, MD / Jonathan Parsons, MD
Coordinator: David Cosmar
Synopsis: Asthma registry for patients diagnosed with asthma who may be eligible for future studies.
Protocol Name: Mechanisms of exercise induced bronchospasm
Sponsor: OSU Asthma Center/NIH
PI: Jonathan Parsons, MD/ John Mastronarde, MD
Coordinator: David Cosmar
Synopsis: Comparing markers of inflammation in asthmatic participants with and without EIB at baseline and after bronchoprovocation with eucapnic voluntary hyperventilation testing (EVH).
Protocol Name: Micro RNA signatures in acute asthma exacerbations
Sponsor: Pulmonary Division/OSU Asthma Center
PI: Clay Marsh, MD; John Mastronarde, MD ; Melissa Hunter, PhD
Coordinator: David Cosmar
Synopsis: This is a non-randomized, cohort study of the patterns of microvesicles in the serum of participants with atopic and non-atopic asthma.
Protocol Name: Exercise-induced Bronchospasm in Cystic Fibrosis
Sponsor: Pulmonary Division/ OSU Asthma Center
PI: John Mastronarde, MD; Stephen Kirkby, MD; Karen McCoy, MD
Coordinator: David Cosmar
Synopsis: This study is designed to determine how often exercise-induced bronchospam occurs in patients with cystic fibrosis.
Protocol Name: Prevalence of exercise-induced asthma in select cohorts of college athletes
Sponsor: Pulmonary Division/ OSU Asthma Center
PI: Jonathon Parsons, MD; John Mastronarde, MD
Coordinator: David Cosmar
Synopsis: This study is investigating how commonly exercise-induced asthma happens in athletes and the best way to diagnose exercise-induced asthma
Protocol: Methacholine Bronchopravocation – Influence of High Potency corticosteroids in Asthma Study (MeCIS)
Sponsor: ALA- ACRC / NIH
PI: John Mastronarde, MD
Coordinator: David Cosmar
Synopsis: This study is being done to see if this methacholine challenge test is a good way of finding out if someone has asthma.
Protocol: Inflammatory Mediators and microRNA Analysis in Premenstrual Asthma
Sponsor: National Institute of Health (NIH)
PI: Jennifer McCallister, MD
Coordinator: David Cosmar
Synopsis: This study is being done to investigate the possible causes of this premenstrual increase in asthma symptoms and to help asthma care providers identify those patients who may suffer from this condition.
COPD/Emphysema
Protocol: The Ohio State University COPD Registry
Sponsor: Pulmonary Division
PI: Philip Diaz, MD, Co-PI: Michael Ezzie, MD
Coordinator: Robin Brookens
Synopsis: The purpose of this study is to help understand the causes of chronic obstructive pulmonary disease (COPD).
Protocol: Long-term Oxygen Treatment Trial (LOTT) Consent for Enrollment, Randomization, and Specimen Banking
Sponsor: National Heart, Lung, and Blood Institute
PI: Philip Diaz, MD
Coordinator: Robin Brookens
Synopsis: This study will help us understand if 24-hour oxygen therapy is helpful for people who have moderately low levels of oxygen in their blood at rest.
Protocol Name: Smoking Cessation and the natural history of HIV-associated emphysema
Sponsor: NIH
PI: Philip Diaz, MD
Coordinator: Karen Martin
Synopsis: The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.in the HIV sero-positive population
Protocol: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Efficacy Of Mp-376 Inhalation Solution Administered For 5 Days Every 28 Days To Prevent Acute Exacerbations In High Risk Copd Patients
Sponsor: MPEX Pharmaceuticals
PI: Philip Diaz, MD
Coordinator: David Cosmar; Rachael Compton
Synopsis: The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug, levofloxacin, when used to treat Chronic Obstructive Pulmonary Disease (COPD).
Interstitial Lung Disease/IPF
Protocol Name: Behavioral Stress, Inflammation and Chronic Lung Disease
Sponsor: Pulmonary Division/Psychiatry Department
PI: Charles Emery, PhD/ Clay Marsh, MD / Philip Diaz, MD
Coordinator: Robin Brookens
Synopsis: To examine the relationship between behavioral stress, inflammation and important outcomes in patients with chronic lung disease.
Protocol Name: Inflammation in Interstitial Lung Disease / Idiopathic Pulmonary Fibrosis
Sponsor: Pulmonary Division
PI: Clay Marsh, MD/ Nitin Bhatt, MD
Coordinator: Rachael Compton
Synopsis: The purpose of this study is to help understand the causes of interstitial lung disease (ILD).
Pulmonary Arterial Hypertension
Protocol Name: Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension - A multicenter, double-blind, randomized, placebo-controlled, parallel group, prospective, event driven Phase IV study
Sponsor: Actelion
PI: Namita Sood, MD
Coordinator: Jessica Smith
Synopsis: The purpose of this study is to evaluate how safe and how effective bosentan is in combination with sildenafil. The combination use will be compared to subjects receiving sildenafil only. Potential subjects will be patients using sildenafil for the treatment of pulmonary arterial hypertension (PAH) who still have symptoms.
Protocol Name: A 12-Week, International, Multicenter, Double Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT 15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension
Sponsor: United Therapeutics
PI: Namita Sood, MD
Coordinator: Jessica Smith
Synopsis: The purpose of this research study is to determine if UT 15C SR will help control the symptoms of PAH and determine if it is safe.
Protocol Name: A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
Sponsor: Actelion
PI: Namita Sood, MD
Coordinator: Jessica Smith
Synopsis: The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug, ACT-064992, when used to treat pulmonary arterial hypertension.
Protocol Name: A Randomized, Multicenter Study of Ambrisentan and Sildenafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension who have Demonstrated a Sub-Optimal Response to Sildenafil
Sponsor: Gilead
PI: Namita Sood, MD
Coordinator: Jessica Smith
Synopsis: This research study will evaluate the combination of ambrisentan and sildenafil.
Protocol Name: A Phase IIIb, multicenter, open-label study of patients with pulmonary arterial hypertension treated with iloprost (inhalation) evaluating safety and inhalation times when converting from power disc-6 to power disc-15 with the I-Neb® AAD
Sponsor: Actelion
PI: Namita Sood, MD
Coordinator: Jessica Smith
Synopsis: The purpose of this research study is to test the safety and tolerability of a new disc, the Power Disc-15 (PD-15) compared to the approved disc, the Power Disc-6 (PD-6).
Protocol: A Multicenter, Double-blind, Randomized Study comparing the Safety and Tolerability of Iloprost inhalation solution delivered by I-neb utilizing Power disc-15 and Power disc-6 in Patients with Symptomatic Pulmonary Arterial Hypertension
Sponsor: Actelion
PI: Namita Sood, MD
Coordinator: Jessica Smith
Synopsis: The main purpose of this clinical research is to compare the safety and tolerability of Ventavis®, using the new power 15 disc and approved power 6 disc up to 12 weeks in subjects with Pulmonary Arterial Hypertension.
Protocol: A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
Sponsor: Actelion
PI: Namita Sood, MD
Coordinator: Jessica Smith
Synopsis: The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug, ACT-064992, when used to treat pulmonary arterial hypertension.
Protocol: Long-term, single-arm, open label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension
Sponsor: Actelion
PI: Namita Sood, MD
Coordinator: Jessica Smith
Synopsis: The purpose of this research study is to test the safety, tolerability, and effectiveness of the investigational drug, ACT-064992, when used to treat pulmonary arterial hypertension
Protocol: Randomized, double-blind, placebo-controlled, multicentre, multi national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). CHEST-1 Study
Sponsor: Bayer Healthcare AG
PI: Namita Sood, MD
Coordinator: Jessica Smith
Synopsis: The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug, BAY 63-2521, when used to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Protocol: Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH)- PATENT-1 Study
Sponsor: Bayer Healthcare AG
PI: Namita Sood, MD
Coordinator: Jessica Smith
Synopsis: The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug, BAY 63-2521, when used to treat pulmonary arterial hypertension (PAH).
Protocol: The expression and significance of miRNA profile and markers of inflammation in patients with pulmonary arterial hypertension
Sponsor: Pulmonary Division
PI: Namita Sood, MD
Coordinator: Megan Sustar
Synopsis: This study is being done to see if blood samples can be tested to determine who might develop PAH, how well drugs will work to treat PAH and to learn more about the development of PAH.
Transplantation
Protocol Name: Pulmonary Complications of Hematopoietic Stem Cell Transplantation (BMT)
Sponsor: NIH
PI: Karen Wood, MD
Coordinator: Anita Kapil
Synopsis: Observational Study. Subject population consists of patients scheduled to undergo hematopoietic stem cell transplantation at the Ohio State University. No active treatment outside of routine clinical care is involved to determine factors contributing to the development of pulmonary disease. Study visits consist of protocol related blood draws, questionnaires, and Spirometry/PFT’s.
Protocol Name: Lung Transplantation Specimen Repository
PI: David Nunley, MD
Coordinator: Pulmonary Division
Synopsis: Lung tissue will be examined to look at biological processes leading to lung disease.
Sarcoidosis
Protocol Name: Stromal Gene Expression during Pulmonary Sarcoidosis
Sponsor: Pulmonary Division
PI: Elliot Crouser, MD
Coordinator: Robin Brookens
Synopsis: A small amount of tissue sample is analyzed for the hereditary material (genes) that may be the cause of sarcoidosis.
Protocol Name: Modulation of Pulmonary Sarcoidosis by Nicotinic Acetylcholine Receptors
Sponsor: American Thoracic Society
PI: Elliot Crouser, MD
Coordinator: Robin Brookens
Synopsis: to see if the nicotine patch is an anti-inflammatory treatment for sarcoidosis
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