Research

Division of Pulmonary, Critical Care, and Sleep Medicine

A variety of clinical research in Pulmonary and Critical Care Medicine is ongoing in the Division, and in allied clinical departments in the Medical Center. The second year of the program is devoted almost entirely to research, with some additional time available in the third year for continuation of projects and completion of data analysis, abstract and paper preparation, and presentation of work at regional and national meetings. Some of the research opportunities for fellows in recent years include the following:

Clinical Research

  • Outcome of Invasive Pulmonary Diagnostic Procedures: Outcome analysis of invasive diagnostic techniques such as bronchoscopy, thoracoscopy, transthoracic lung biopsy etc. in immunocompromised patients is being performed by Dr. O'Donnell and colleagues.
  • Treatment of malignant pleural effusion: Outcome analysis and cost benefit analysis of treatment of malignant pleural effusion is under study by Dr. Read.
  • Drug studies: Serious community acquired pneumonia, anti-TNF antibody in sepsis syndrome, thrombolytic therapy of pulmonary embolism.
  • DVT prophylaxis in ICU-prospected double-blind study comparing LMWH vs SQ hyparin in DVT prophylaxis funded by ACCP and overseen by Dr. Kuru.
  • Ventilator weaning protocol success by Dr. Anderson.

Please click here to see more information on our 2017 NTM & Bronchiectasis Physician/Patient Conference.

Ongoing Clinical Trials and Faculty Research

  • Insmed INS212: A Randomized Open-Label, Multicenter Study of LAI in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium Complex (MAC) that are Refractory to Treatment
    PI: Dr. Anne O'Donnell
    Purpose: To evaluate the efficacy of LAI administered when added to Standard of Care SOC, for achieving culture conversion, when compared to Standard of care alone

  • INSMED 312 An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment
    PI: Dr. Anne O'Donnell

  • INSMED 312 An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment
    PI: Dr. Anne O'Donnell

  • RIN-PH-201: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease
    PI: Dr. Tunay Kuru
    Purpose: The purpose of this study is to investigate inhaled treprostinil (brand name Tyvaso®), in patient with Pulmonary Arterial Hypertension with ILD and CPFE.

  • RIN-PH-202:An Open-Label Extension study of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease
    PI: Dr. Tunay Kuru
    Purpose: The purpose of this study is to investigate Inhaled Treprostinil, in patients with Pulmonary Arterial Hypertension with CPEE. This open-label study will evaluate the safety of continued therapy with Inhaled Treprostinil in subjects who have completed RIN-PH-201. IRB # 15-1484. This study hypothesizes that long-term safety findings will be similar to those observed in the randomized, placebo controlled study (RINPH-201).

  • A Phase 2a, 2-part, Randomized, Double-blind, Placebo-controlled, Incomplete Block Crossover Study to Evaluate the Safety and Efficacy of VX-371 Solution for Inhalation With and Without Oral Ivacaftor in Subjects With Primary Ciliary Dyskinesia
    PI: Dr. Anne O'Donnell
    Co-PI: Dr. Christine Fleury
    Purpose: This study is in two parts. Part A is being done to learn more about the safety and effects of the inhaled combination of VX-371 with and without hypertonic saline (HS) (saltwater), in patients with PCD, and Part B is optional and is being done to learn more about the safety and effects of VX-371 given with and without HS and with a medication patients swallow, called ivacaftor.

  • TDE-HF-301 A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) in Heart Failure with Preserved Ejection Fraction (HFpEF)
    PI: Dr. Tunay Kuru
    Purpose: The purpose of this study is to see how oral treprostinil works to treat pulmonary hypertension (PH) associated with left-sided heart failure with preserved ejection fraction (HFpEF).

  • TDE-HF-302- An Open-label Extension Study of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) Associated with Heart Failure with Preserved Ejection Fraction (HFpEF) - A Long-Term: Follow-up to Study TDE-HF-301
    PI: Dr. Tunay Kuru
    Purpose: The purpose of this study is to see how oral treprostinil works to treat pulmonary hypertension (PH) associated with left-sided heart failure with preserved ejection fraction (HFpEF).

  • Registry for a Global Collaborative Network for Pulmonary Fibrosis
    PI: Dr. Cristina Reichner
    Purpose: The purpose is to contribute to the existing knowledge of the disease. To determine if diseases that cause scarring of the lung are inherited.

  • OrPHeUS AC-005-510 Multicenter, retrospective chart review of first time Opsumit (macitentan) users in the United States
    PI: Dr. Kuru
    Purpose: The Opsumit Users (OPUS; NCT02126943) registry is a post-marketing requirement for Opsumit (PMR 2093-1), under section 505 (o) of the Food, Drug and Cosmetic Act as part of NDA 204410 approved on 18 October 2013. OPUS is a multicenter, prospective, observational drug registry of patients newly treated with Opsumit in the US. It was developed to characterize the safety profile of Opsumit (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting. OPUS has a target of enrollment of 5000 Opsumit new users by October 2018.
    However, it is expected that the recruitment target of the OPUS registry cannot be achieved within the planned time period. The OrPHeUS study is set up to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size. OrPHeUS and OPUS data will be pooled in order to characterize the hepatic safety profile of Opsumit in the post-marketing setting.

  • A Double-Blind, Placebo Controlled, Multi-Centre, Clinical Trial to Investigate the Efficacy and Safety of 24 months of Therapy with Inhaled Colistimethate Sodium in the Treatment of Subjects with Non-Cystic Fibrosis Bronchiectasis Chronically Infected with Pseudomonas Aeruginosa (P.Aeruginosa)
    PI: Dr. Anne O'Donnell
    Co-PI: Dr. Christine Fleury
    Purpose: The purpose of the trial is to investigate if the use of inhaled Promixin® (colistimethate sodium), administered twice daily for 24 months, delays the time to the first pulmonary exacerbation compared to placebo in subjects with non–cystic fibrosis (CF) bronchiectasis chronically infected with P. aeruginosa.

  • INS 1007-201 A randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability and Pharmacokinetics of INS1007 Administered once a Daily for 24 weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis The Willow Study
    PI: Dr. Anne O'Donnell
    Purpose: To evaluate the effect of INS1007 compared with placebo on time to first pulmonary exacerbation over the 24-week treatment period.

  • Scleroderma Lung Study III : trial for  scleroderma  interstitial  lung  disease
    PI: Dr. Christina Reichner

    Purpose: This one is for treatment naive patients with less than 7 years of disease (limited or diffuse scleroderma). Everyone will get mycophenolate (paid for by the study), and then randomized to placebo or Pirfenidone.

  • A double blind RCT evaluating the efficacy and safety of oral nintedanib in patients with Systemic Sclerosis associated interstitial lung disease.
    PI: Dr. Christina Reichner