NCT04619602

Inhaled Treatment for Bronchopulmonary Dysplasia

Pilot Study of an Inhaled Treatment for Bronchopulmonary Dysplasia

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 29 Days – 365 Days
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 \[during administration and tracked for next 7 days\].

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	GSNO	Intervention will be 30 minutes of inhaled GSNO agent in enrollment blocks of three subjects/dose (0.5 mL/kg of 0.25 mM, 0.5 mM, or 1 mM) to infants.

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2020-11-06
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study