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出境医 / 临床实验 / Open-label Study of Inhaled RVT-1601 in Preterm Infants

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

Study Description
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.


Condition or disease Intervention/treatment Phase
Respiratory Morbidities of Prematurity (RMP) Drug: RVT-1601 Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : May 29, 2020
Actual Study Completion Date : May 29, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: RVT-1601 Low Dose
Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer
 Drug: RVT-1601
Inhaled RVT-1601 administered once daily over two days
Experimental: RVT-1601 Mid Dose
Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer
 Drug: RVT-1601
Inhaled RVT-1601 administered once daily over two days
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   32 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
United States, California
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States, 92123
Sponsors and Collaborators
Respivant Sciences GmbH
Respivant Sciences Inc.
Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE October 1, 2019
Actual Primary Completion Date May 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • Change in heart rate [ Time Frame: Pre-dose and 15 minutes post-dose ]
    Assessment of heart rate (beats/min)
  • Change in blood pressure [ Time Frame: Pre-dose and 15 minutes post-dose ]
    Assessment of systolic and diastolic blood pressure (mmHg)
  • Change in oxygenation [ Time Frame: Pre-dose and 15 minutes post-dose ]
    Assessment of peripheral capillary oxygen saturation (SpO2)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • Peak plasma concentration (Cmax) [ Time Frame: 30 minutes post-dose ]
    Assessment of peak plasma concentration of RVT-1601
  • Total urine excretion [ Time Frame: 8 hours post-dose ]
    Assessment of total urine content of RVT-1601
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label Study of Inhaled RVT-1601 in Preterm Infants
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Respiratory Morbidities of Prematurity (RMP)
Intervention  ICMJE Drug: RVT-1601
Inhaled RVT-1601 administered once daily over two days
Study Arms  ICMJE
  • Experimental: RVT-1601 Low Dose
    Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer
    Intervention: Drug: RVT-1601
  • Experimental: RVT-1601 Mid Dose
    Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer
    Intervention: Drug: RVT-1601
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2020) 		8
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2019) 		6
Actual Study Completion Date  ICMJE May 29, 2020
Actual Primary Completion Date May 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 32 Months to 35 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04007120
Other Study ID Numbers  ICMJE RVT1601-RMP-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Respivant Sciences Inc. ( Respivant Sciences GmbH )
Study Sponsor  ICMJE Respivant Sciences GmbH
Collaborators  ICMJE Respivant Sciences Inc.
Investigators  ICMJE Not Provided
PRS Account Respivant Sciences Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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