1397-0012: A randomised, double-blind, placebo-controlled, parallel group, dose-finding study evaluating efficacy, safety and tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis (Airleaf™).

Date Added
September 22nd, 2022
PRO Number
Pro00122904
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis, Lung, Pulmonary
Summary

This trial will investigate 3 dose regimens of BI 1291583 compared to placebo in patients suffering from bronchiectasis to evaluate efficacy, safety and tolerability of BI 1291583 in preventing pulmonary exacerbations and to provide dose-ranging data. Patients will be treated for at least 24 weeks up to a maximum of 48 weeks. Since sputum NE is a biomarker linked to risk of exacerbations, an interim assessment of NE activity in sputum at 12 weeks of treatment will act as an early confirmation of pharmacodynamic activity.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 1b, Multi-center Study of IV Gallium Nitrate in Patients with Cystic Fibrosis who are colonized with Nontuberculous Mycobacteria (the ABATE study)

Date Added
September 1st, 2022
PRO Number
Pro00123092
Researcher
Christina Mingora

List of Studies

Keywords
Cystic Fibrosis, Lung, Nontuberculous mycobacteria (NTM), Pulmonary
Summary

This is a prospective, multicenter open-label study in adults with CF who are colonized with NTM. Subjects will receive two 5-day infusion cycles of IV gallium. The study will evaluate the safety and antimycobacterial effect of two 5-day infusions of IV gallium. Subjects will be on study for up to 148 days, with a screening period of up to 7 days and active study period up to 20 days. About 40 people with CF who are 18 years of age or older will take part in this study at about 10 hospitals and clinics around the country.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer

Date Added
August 2nd, 2022
PRO Number
Pro00121443
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients who have been diagnosed with advanced non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using SBRT plus the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the addition of SBRT increases the life of patients by 6 months or more compared to the usual approach. The study drugs are nivolumab and ipilimumab. Participants can expect to be on this study for up to 2 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Development of a nontuberculous mycobacterial pulmonary disease symptom scale (NTM-SS)

Date Added
July 12th, 2022
PRO Number
Pro00119468
Researcher
Patrick Flume

List of Studies