Clinical Research Directory

Repeat Treatment With Metered Cryospray in Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

This study is being conducted to determine the safety of repeat metered cryospray (MCS) treatment in patients with COPD with chronic bronchitis previously treated with MCS.

Study of COPD Subgroups and Biomarkers

SPIROMICS I, SPIROMICS II, and SPIROMICS III are longitudinal observational studies of Chronic Obstructive Pulmonary Disease (COPD) cohort. SPIROMICS I had two primary aims: (1) To find groups of patients with COPD who share certain characteristics; (2) To find new ways of measuring whether or not COPD is getting worse and to provide new ways of testing whether a new treatment is working. SPIROMICS II had three primary aims: (1) To define the natural history of "smokers with symptoms despite preserved spirometry" and characterize the airway mucus abnormalities underlying this condition; (2) To determine the radiographic precursor lesion(s) for emphysema and identify the molecular phenotypes underlying airway disease and emphysema; (3) To advance understanding of the biology of COPD exacerbations through analysis of predisposing baseline phenotypes, exacerbation triggers and host inflammatory response. SPIROMICS III has three primary aims: (1) To identify the main forms of smoking-related airway disease that are caused by pathological airway mucus, their biological underpinnings, and their physiological significance; (2) To identify longitudinal trajectories in established and novel CT measures of emphysema, test how they predict COPD progression, and define their underlying biology; (3) To identify environmental and social determinants of health that impact disease severity and progression and their influence on lung structure, biology, and health disparities in COPD.

Emphysema Research Registry and Biosample Repository

The Comprehensive Lung Center (CLC) at the University of Pittsburgh Medical Center (UPMC Health System) provides patients with any type of breathing or lung disorder a full range of diagnostic and therapeutic services. The Emphysema/COPD Research Center (ECRC) is a specialty clinic, within this center, that attempts to advance the understanding of emphysema and to evaluate new therapies for patients with emphysema. The Emphysema Research Registry will enable pulmonary research physicians to: 1) gather information and create a research registry of people who have been diagnosed with emphysema; 2) utilize this research registry with the purpose of conducting research that attempts to advance the understanding of emphysema and to evaluate new therapies; and, 3) use the research registry to identify potential candidates for future research programs. These aims will be achieved by the collection of DNA (genetic material)for analysis and storage in addition to pulmonary function tests and other medical information.

Clinical Study of the Pulsed Electric Field Ablation System in Chronic Obstructive Pulmonary Disease

This is a prospective, randomized, parallel group, sham-controlled, multicenter clinical trial. The objective is to evaluate the safety and effectiveness of pulsed electric field ablation system manufactured by Suzhou Hengruihongyuan Medical Technology Co., Ltd. for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis. A total of 210 patients will be randomized into the experimental group and the sham group (2:1).

A Clinical Evaluation of the RheOx Bronchial Rheoplasty System

This is a prospective, multicenter, single arm and open-label clinical trial to evaluate the performance, effectiveness and safety of RheOx™ system in the treatment of the symptoms of chronic bronchitis in adult moderate to severe COPD patients.

BROnchoalveolar Investigations of Never-smokers With Chronic Obstruction From the Swedish CardioPulmonary bioImage Study

Obstructive lung disease is an increasing global health problem of pandemic proportions, with COPD alone affecting \>10% of the population. Smoking is the main and most well studies risk factor for developing COPD. However, chronic airway obstruction also in never-smoking populations has recently been recognized as an increasing health problem. In the clinical segment (PI: Prof. C. Magnus Skold), 1000 subjects from the Swedish national SCAPIS study will be clinically well characterized in one of the six Swedish University Hospital Respiratory clinics (clinical site PIs: Anders Andersson, Leif Bjermer, Anders Blomberg, Christer Janson, Lennart Persson, Magnus Skold). This first screening includes all never-smokers with COPD identified in the SCAPIS study. A subset of 300 subjects from the groups of Healthy never-smokers, current-smokers with normal lung function, current-smokers with COPD, ex-smokers with COPD, and never-smokers with COPD will be selected for the Bronchoscopy segment, were sampling will be performed from a number of anatomical locations, including bronchial biopsies, airway epithelial brushings, and bronchoalveolar lavage. Serum, plasma, and urine samples will also be collected. In the systems medicine segment (PI: Assoc. prof Asa M. Wheelock), alterations at the epigenetic, mRNA, microRNA, proteome, metabolome and microbiome level will be performed from multiple lung compartments (airway epithelium, alveolar macrophages, exosomes, and bronchoalveolar exudates). By means of biostatistics and bioinformatics approaches, specific mediators and molecular pathways critical in the pathological mechanisms of obstructive lung disease related to never-smoker disease phenotypes will be identified. In the immunohistochemistry segment (PI: Prof. Jonas Erjefalt), a number of molecules of relevance for disease pathology will be investigated in bronchial biopsies collected from the 300 subjects in the Bronchoscopy segment.

Clinical & Systems Medicine Investigations of Smoking-related Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) is an increasing global health problem, which primarily increases among the female population. The purpose of this study is to perform in-depth clinical and molecular characterizations of early stage COPD patients, as well as healthy never-smoker and at-risk smoking control populations to identify molecularly related subgroups patients, including gender-related sub-phenotypes of COPD.

Pulmonary Deposition of Ultrasound Rock Salt Aerosol Inhalation Therapy

In the in vitro modeling phase, the investigators plan to use a realistic human upper respiratory tract model and an asymmetric ideal bronchial tree model. By combining 3D printing experiments with CFD simulations, the investigators will investigate the respiratory tract deposition rate and distribution of micro - moist particles in ultrasound rock salt aerosol inhalation therapy. This will be compared with a small - volume nebulizer to verify the effectiveness of ultrasound rock salt aerosol inhalation therapy and lay the foundation for further research on the application of this inhalation technique to other drug formulations. In the clinical phase, the investigators plan to have subjects inhale radioactive aerosols and use PET/CT imaging technology to assess the deposition rate of aerosol particles in the lungs. By quantitatively analyzing the images, the investigators will study their distribution characteristics in real human bodies to verify the accuracy of the in vitro models and the potential for clinical application.

RejuvenAir® System Trial for COPD With Chronic Bronchitis

Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality.

COPD Patient-Powered Research Network

The COPD Patient-Powered Research Network (COPD PPRN) is a patient research registry with the goal of enrolling 75,000 or more COPD patients and those at risk who are willing to share their heath information over several years and participate in research. The COPD PPRN has built an online platform to allow volunteers to enroll electronically, complete surveys, be contacted about studies they qualify for and become connected to COPD resources. The goal of the registry is to speed research to find better treatments for COPD and ultimately a cure.