Inhaled Treatment for Bronchopulmonary Dysplasia

Status Suspended

Clinical Trial Summary

The primary objective of this study is to provide expanded access of S-nitrosylation therapy for the treatment of bronchopulmonary dysplasia

Clinical Trial Description

Open label study with 20 participants, open-label, with block dose escalation of 3 subjects/dose (0.5 mL/kg of 0.25 mM, 0.5 mM, or 1 mM). A minimum of seven days of surveillance will separate dosing blocks. An additional 11 subjects will be enrolled at the maximum 1 mM block (5x10-7 moles/kg). The primary outcomes are safety during 30 minutes of inhalation, and for 4 hours after inhalation, as measured by occurrence of adverse events related to the treatment + time period [during administration and tracked for next 7 days]. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04619602
Study type	Interventional
Source	University Hospitals Cleveland Medical Center
Contact
Status	Suspended
Phase	Phase 1
Start date	August 1, 2024
Completion date	September 1, 2025

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