Respiratory Morbidities of Prematurity (RMP) Clinical Trial
Official title:
Open-label Study to Assess the Safety, Tolerability, Feasibility, and Pharmacokinetics of Inhaled RVT-1601 in Preterm Infants at High-risk for Long-term Respiratory Morbidities
Preterm birth predisposes infants to greater risk for respiratory morbidities and the need
for pulmonary care compared to term infants both in the short-term and long-term. In the
short-term, preterm birth is a high risk factor for development of bronchopulmonary dysplasia
(BPD), the second most common chronic pediatric respiratory disease after asthma. In the
long-term, following discharge from the neonatal intensive care unit (NICU) and the hospital,
preterm birth carries a high risk for respiratory morbidities (e.g., wheezing, cough, doctor
visits, and hospitalizations for respiratory infections) and resource use, which in turn
predisposes infants to the development of lung diseases in childhood and adulthood, including
airway hyperresponsiveness, asthma, and chronic obstructive pulmonary disease (COPD). There
is a significant unmet need for safe and efficacious approaches in the prevention and
treatment of respiratory morbidities of prematurity.
The study will be conducted in the neonatal intensive care unit (NICU) in preterm infants to
determine safety, tolerability and lung delivery performance of RVT-1601, a new inhalation
formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer/face
mask.
n/a