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

NCT ID: NCT04007120

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-05-29

Brief 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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

RVT-1601 Low Dose

Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer

Group Type: EXPERIMENTAL

RVT-1601

Intervention Type: DRUG

Inhaled RVT-1601 administered once daily over two days

RVT-1601 Mid Dose

Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer

Group Type: EXPERIMENTAL

RVT-1601

Intervention Type: DRUG

Inhaled RVT-1601 administered once daily over two days

Interventions

RVT-1601

Inhaled RVT-1601 administered once daily over two days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Preterm infants between 32 weeks 0 days and 34 weeks 6 days of PMA
• Born between 24 weeks 0 days and 29 weeks 6 days of estimated GA
• Requiring minimal or no respiratory support (i.e., supplemental oxygen with <2 liters per minute of nasal cannula flow acceptable)
• Body weight appropriate for gestational age
• Written informed consent obtained from at least one of the parents or legal guardians

Exclusion Criteria

• Requiring invasive or noninvasive respiratory support (e.g., mechanical ventilation, CPAP)
• Clinically unstable (i.e. unable to maintain SpO2 between 90-95 % , escalating respiratory support in the past 24 hours)
• Major congenital anomaly (chromosomal, renal, cardiac, hepatic, neurologic or pulmonary malformations)
• Significant cardiac disorder (i.e., pulmonary hypertension)
• History of major surgical procedure
• Any condition that would preclude receiving study drug or performing any study-related procedures
• Participation in any other investigational drug study
• History of hypersensitivity or intolerance to cromolyn sodium

• Minimum Eligible Age: 32 Months
• Maximum Eligible Age: 35 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Respivant Sciences Inc.

INDUSTRY

Sponsor Role: collaborator

Respivant Sciences GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, United States

Countries

United States

Other Identifiers

RVT1601-RMP-01

Identifier Type: -

Identifier Source: org_study_id