The Pulmonary and Critical Care Division has NIH, ALA, Foundation and pharmaceutically funded basic and clinical research programs.

A. BASIC RESEARCH

1. McCormack laboratory
    Lab members
      Sijue Wan
      Huixing Wu

  Projects
    Role of alveolar epithelium host defense and lung fibrosis
      a. Direct antimicrobial properties of the collectins
      b. Structure and function of SP-A and SP-D
      c. Effect of oxidant stress on collectin function
      d. Role of the Akt pathway in host defense and pulmonary fibrosis

2. McGraw laboratory
    Lab Members
      Cheryl Theiss
      Kari Brown
      Judy Cain
    Projects
      Contribution of the G protein coupled receptors to airway tone and lung homeostasis. Emphasis is on 2-adrenergic, thromboxane, and other prostanoid receptors, and pathways of crosstalk between receptor systems.

3. Young laboratory
    Molecular mechanisms of pulmonary fibrosis
      Peter Gulleman

4. Trapnell laboratory
    Lab members
      Kanji Uchida

    Projects
      Role of GM CSF in pulmonary innate immunity and disease.

5. Pasula laboratory
    Lab members
      Banu Kesavalu

B. CLINICAL RESEARCH

1. Rare Lung Disease Consortium
    The Rare Lung Disease Consortium is an NIH sponsored, Cincinnati-based network of institutions which perform cooperative trials in rare lung disease. Diseases that are currently under study by the MCCC include:

      Lymphangioleiomyomatosis
      Pulmonary Alveolar Proteinosis
      Alpha One Antitrypsin Deficiency
      Pediatric Interstitial Lung Disease
      Idiopathic Pulmonary Fibrosis

MILES Trial for LAM, "A double-blind placebo controlled randomized trial of sirolimus in patients with lymphangioleiomyomatosis (LAM)" sponsored by the NIH, Rare Lung Disease Consortium, Wyeth, The LAM Foundation, and Tuberous Sclerosis Alliance (P.I. McCormack)

2. Midwest Critical Care Consortium

The MCCC is a network of ICUs around the Midwest that conduct cooperative trials. New proposals are presented to the group, critiqued, selected by consensus and implemented. The MCCC meets semiannually in Columbus and at the American Thoracic Society Meeting. Current trials include the WIRE study, which will test the predictive value of muscular weakness on readmission to the ICU, and an ICU staffing study, which will evaluate provider satisfaction and patient length of stay in two different ICU staffing models.

  Current MCCC members include
      University of Cincinnati
      Ohio State University
      University of Michigan
      Henry Ford Hospital
      Medical College of Toledo
      Case Western University
      University of Chicago
      Indiana University
      University of Iowa

3. Cystic fibrosis The Cincinnati CF Center is one of 18 Therapeutic Development Network sites for the Cystic Fibrosis Foundation. Our cystic fibrosis physicians are investigators on multiple TDN studies including:
  1. P2Y2 agonist activation of alternative chloride channels, Inspire Pharmaceuticals
  2. Modifier genes in cystic fibrosis

  Current non TDN studies
    1. "Safety, efficacy, tolerance and pharmacokinetics of meropenum for the treatment of CF exacerbations'.
    2. Isolation and characterization of a clonal strain of Achromobacter xylosoxidans in the Cincinnati CF population.

4. VA GAPS
Dr. Render is Director of the VA Getting at Patient Safety (GAPS) Center, funded to advance safety in healthcare. The GAPS Center has as its focus creating learning in order to advance a safety culture and understanding and improving tools that support technical work and safety in healthcare. GAPS participates in both local safety efforts in Cincinnati including development with the Greater Cincinnati Health Coalition a Patient Safety Collaborative that includes most healthcare organizations in the greater Cincinnati area, and the University of Cincinnati Patient Safety Workgroup. Funded research interests have included development of an automated ICU severity of illness model using the VA database with the long-range goal of advancing quality of ICU care, evaluating healthcare costs within the Department of Veterans Affairs, analysis of new paths to failure with bar coding, and usability of Reminders in the VA computer system. The GAPS Center has actively been developing reproducible strategies to create components of a patient safety culture using VISN 10 as a test environment.

5. Sleep Research
Pillar study-A cooperative study evaluating the efficacy of implants which stiffen the soft palate is currently being evaluated in patients at University Pointe (P.I.-Steward, Co-I-Surdulescu)

6. Pharmaceutical trials in critically ill patients
Dr. Khalid Almoosa directs the clinical trials program. We have two research coordinators, Brandon Meranda and Emily Werff.

Tifacogin in community acquired pneumonia "A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-blind, Three-Arm Study to Evaluate the Safety and Efficacy of Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) Administration in Patients with Severe Community-Acquired Pneumonia" which is sponsored by Chiron Corporation. (P.I. Almoosa)

Coated catheter study "A Controlled, Randomized, Single-Blind, Multi-Center Pivotal Clinical Study Using Angiotech CVC to Prevent Bacterial Colonization on Short-Term Central Venous Catheters" sponsored by Angiotech Pharmaceuticals. (P.I. Almoosa)

TAK-242 in severe sepsis "A Pivotal, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-242 in Adults with Severe Sepsis" and sponsored by Takeda Global Research & Development Center, Inc (P.I. Almoosa)

7. Pharmaceutical trials in pulmonary disease

Fospropofol for sedation in bronchoscopy sponsored by MGI Pharma and titled, "A Phase 3, Randomized, Double-Blind, Dose-Controlled Study to Assess the Efficacy and Safety of AQUAVAN® (Fospropofol Disodium) Injection for Minimal-to-Moderate Sedation in Patients Undergoing Flexible Bronchoscopy" (P.I. Panos)

Pirfenidone in idiopathic pulmonary fibrosis (IPF), sponsored by InterMune Pharmaceuticals and titled, "A Randomized, Double Blind, Placebo-Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis" (P.I. Panos)

Tiotropium vs. combivent in COPD, sponsored by Boehringer-Ingelheim and titled, "A Randomized, Double-Blind, Double-Dummy, Parallel Group Trial Comparing 12 Weeks Treatment with Tiotropium Inhalation Capsules 18 mcg via the HandiHaler® Once Daily to Combivent® Inhalation Aerosol CFC MDI 2 Actuations q.i.d. in COPD patients currently prescribed Combivent® Inhalation Aerosol CFC MDI" (P.I. Panos)

Long Term Oxygen Therapy Trial (LTOT), A randomized controlled trial to evaluate the effect of supplemental oxygen on morbidity and mortality related to desaturation with exercise and sleep. Sponsored by the NHLBI. (P.I. Phil Diaz, OSU, site PI-Panos)

8. Investigator initiated clinical studies
Prevalence of COPD at the VA-A questionnaire and spirometery based study to evaluate the prevalence of COPD in an unselected population of Veterans. (P.I.-Panos).

Association between adherence to GOLD criteria and clinical outcomes in patients with COPD-(P.I.-Panos).