Respiratory Morbidities of Prematurity (RMP)Phase 1NCT04007120
Open-label Study of Inhaled RVT-1601 in Preterm Infants
A Phase 1 study testing RVT-1601 in people with Respiratory Morbidities of Prematurity (RMP), run by Respivant Sciences GmbH at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 32 to 35 months
- Conditions the study is for
- Respiratory Morbidities of Prematurity (RMP)
- What is being tested?
- RVT-1601
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 29 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 35 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
About this study
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.
- Being tested
- RVT-1601
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVT-1601Drug
Inhaled RVT-1601 administered once daily over two days
| Study group | Role | What they receive |
|---|---|---|
| RVT-1601 Low Dose | Experimental | Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer Receives: Drug: RVT-1601 |
| RVT-1601 Mid Dose | Experimental | Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer Receives: Drug: RVT-1601 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate
Assessment of heart rate (beats/min)
Measured: Pre-dose and 15 minutes post-dose
Change in blood pressure
Assessment of systolic and diastolic blood pressure (mmHg)
Measured: Pre-dose and 15 minutes post-dose
Change in oxygenation
Assessment of peripheral capillary oxygen saturation (SpO2)
Measured: Pre-dose and 15 minutes post-dose
Secondary outcomes (2)
Peak plasma concentration (Cmax)
Assessment of peak plasma concentration of RVT-1601
Measured: 30 minutes post-dose
Total urine excretion
Assessment of total urine content of RVT-1601
Measured: 8 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Oct 2019
- Primary completion29 May 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Morbidities of Prematurity (RMP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respivant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Respivant Sciences Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007120
- Sponsor's protocol ID
- RVT1601-RMP-01
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04007120
- Acronym / sponsor ID
- RVT1601-RMP-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Respivant Sciences GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Respivant Sciences Inc.
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RVT-1601 Low Dose | Experimental | Drug: RVT-1601Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer |
| RVT-1601 Mid Dose | Experimental | Drug: RVT-1601Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer |
Who may qualify
- Ages
- 32 to 35 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RVT-1601Inhaled RVT-1601 administered once daily over two days | Drug | RVT-1601 Low Dose, RVT-1601 Mid Dose |
Primary outcome
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)
2 secondary outcomes
Peak plasma concentration (Cmax)
Time frame: 30 minutes post-dose
Total urine excretion
Time frame: 8 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RVT-1601 in people with Respiratory Morbidities of Prematurity (RMP), run by Respivant Sciences GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart rate (time frame: Pre-dose and 15 minutes post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.