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OpenTrials
Completed

NCT Number: NCT04007120

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

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.

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Key information

Conditions

Respiratory Morbidities of Prematurity (RMP)

Age range

32 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, 92123, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RVT-1601

Drug

Inhaled RVT-1601 administered once daily over two days

Primary outcomes

  1. Change in heart rate

    Time frame: Pre-dose and 15 minutes post-dose

    Assessment of heart rate (beats/min)

  2. Change in blood pressure

    Time frame: Pre-dose and 15 minutes post-dose

    Assessment of systolic and diastolic blood pressure (mmHg)

  3. Change in oxygenation

    Time frame: Pre-dose and 15 minutes post-dose

    Assessment of peripheral capillary oxygen saturation (SpO2)

Secondary outcomes

  1. Peak plasma concentration (Cmax)

    Time frame: 30 minutes post-dose

    Assessment of peak plasma concentration of RVT-1601

  2. Total urine excretion

    Time frame: 8 hours post-dose

    Assessment of total urine content of RVT-1601

Sponsors and collaborators

Lead sponsor

Respivant Sciences GmbH

Industry

Collaborators

  • Respivant Sciences Inc.

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2019
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.