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IRB No. 12-009-2 (Dr. Mark Metersky, PI): Bronchiectasis Research Registry: A Consolidated Database of Non-Cystic Fibrosis Bronchiectasis Patients from Major Clinical and Research Institutions

Study description not available

IRB No. 17-045-2: The Airway Inflammatory Profile of E-Cigarette Users

Study objective: The research study is about how the human body, particularly the airways, react to the regular use of e-cigarettes. The purpose is to show that regular use of e-cigarettes can be associated with airway inflammation in the sputum of regular users of e-cig. We intend to study if the regular use of e-cig, in a simliar way to conventional cigarettes, can trigger an inflammatory response in the airways. Hypotheses: 1. subjects who use e-cigarettes have evidence of airway inflammation when compared to healthy non-smoker subjects 2. Subjects who smoke regular tobacco cigarettes have evidence of more airway inflammation than e-cigarette users. 3. Subjects who use e-cigs with flavoring, e.g. chocolate, or regular cigarettes with flavoring (e.g. menthol) will have more airway inflammation than e-cig and regular cigarette users who don't use flavored products, e.g. menthol. Aims: 1. We plan to characterize airway inflammation profile in e-cig users compared to healthy non-smokers 2. We plan to characterize the airway inlfammatory profile of tobacco cigarette smokers compared to e-cig users. 3. We plan to characterize the effect of menthol in e-cigarettes and tobacco cigarettes on the airway inflammatory profile.

IRB No. 24-094-1 (Dr. Omar Ibrahim, PI): Before-After Operational Data Collection Study Protocol - UConn

The diagnosis managment of lung nodules can be difficult. Current guidelines recommend that pulmonary nodules are managed based upon their probability of malignancy. Despite established guidelines, prior studies estimate that 60-70% of patients with ILNs are not followed up in a timely fashion in accordance with guidelines. To address the management and diagnostic challenges, Optellum has developed Virtual Nodule Clinic (VNC). VNC is an FDA-cleared, web-based, end-to-end software solution early lung cancer diagnosis. University of Connecticut Health (UConn) will be using VNC for routine clinical management of pulmonary nodule patients. As such, UConn offers an ideal environment in which to evaluate the real-world clinical utility of VNC. As part of this partnership, UConn will work with Optellum to evaluate whether use of VNC leads to an improvement in the number of pulmonary nodule patients being followed up and in the pulmonary nodule care pathway. All patients enrolled in UConn';s pulmonary nodule clinic will be eligible. The number of subjects with data collection is unspecified and will depend on the number of patients seen during different phases of the study. The data collection will have three parts: Phase 1: Baseline pre-VNC installation: operational data will be extracted from patient charts up to 6 months prior to the ';Go live'; date of Optellum';s VNC at UConn. Ramp-up period: This is the period during which UConn VNC users are being trained and migrating from their existing workflow, while the VNC workflow is being customized to their feedback. Phase 2: Active Patient Discovery post-VNC installation: operational data will be collected for the 3-12 months post-installation of VNC. During this time the Patient Discovery feature of VNC will be in active use by UConn VNC users.

IRB No. U25-159-1 (Dr. Ameer Rasheed, PI): A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Subjects with Progressive Pulmonary Fibrosis (PPF)

The Sponsor is developing AP01 (also referred to in this document as the “study drug”) for use in the treatment of Progressive Pulmonary Fibrosis. AP01 is an experimental drug that we hypothesize may slow your PPF symptoms. You will inhale the study drug using the eFlow® Nebulizer System. The nebulizer used to deliver AP01 is approved in Europe, but is an investigational device for use in the United States and Canada (not approved by FDA or Health Canada).

IRB No. U25-153-1 (Dr. David Fraulino, PI): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101 (Clofazimine Inhalation Suspension) When Added to Guideline-Based Therapy in Participants with Pulmonary Nontuberculous Mycobacterial Infection (Part A) Followed by an Open-Label Extension (Part B)

MannKind is developing an inhaled suspension of clofazimine, MNKD-101 (hereafter referred to as Clofazimine Inhalation Suspension), to be delivered directly to the site of infection in the lungs via a jet nebulizer. Efficacy data from relevant nonclinical models support the evaluation of Clofazimine Inhalation Suspension for the treatment of pulmonary NTM infection. The primary objective of Part A will be to compare the efficacy of Clofazimine Inhalation Suspension versus placebo when added to GBT as assessed by the co-primary endpoints, sputum culture conversion and change in Quality of Life-Bronchiectasis Respiratory Symptoms Score (QoL-B RSS).