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

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