NCT04007120

Open-label Study of Inhaled RVT-1601 in Preterm Infants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Respivant Sciences GmbH · Industry
• Sex: All
• Age: 32 Months – 35 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Respiratory Morbidities of Prematurity (RMP)

Interventions

Type	Name	Description
DRUG	RVT-1601	Inhaled RVT-1601 administered once daily over two days

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-05-29
• Completion: 2020-05-29
• First posted: 2019-07-05
• Last updated: 2020-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study