BronchiolitisPhase 1NCT03748173
Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04
A Phase 1 study testing Aerosolized Infasurf in people with Bronchiolitis, run by ONY at 1 site in United States.
Trial summary
Delivery of aerosolized Infasurf to bronchiolitis patients with who are not on assisted ventilation can provide sufficient delivery of Infasurf to small airways to improve ventilation and thereby shorten the duration of the respiratory illness. Read more about this study
- Who is it for?
- Ages 0 to 4 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Aerosolized Infasurf
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2019to 21 Oct 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 0 to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant ≤ 4 months of age admitted to the PICU with the clinical diagnosis of bronchiolitis
- Severe illness as reflected by a bronchiolitis score ≥ 4 and requiring high flow nasal cannula or continuous positive airway pressure for respiratory support
- Within 4 hours of PICU admission.
Who cannot join
- Need for non-invasive BiPAP or invasive ventilation
- Significant Co-morbidities
- Chronic lung disease (evidenced by supplemental oxygen, home ventilation, or chronic diuretic therapy for CLD)
- Unrepaired congenital heart disease
- Immune compromise
- Neuromuscular weakness
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- Tracheostomy
- Influenza as the etiologic agent of bronchiolitis
- Inability to stabilize the infant to a bronchiolitis score < 8
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23298
About this study
Official title: Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04 A Pilot Study of Aerosol Surfactant for Bronchiolitis in Infants
Delivery of aerosolized Infasurf to bronchiolitis patients with who are not on assisted ventilation can provide sufficient delivery of Infasurf to small airways to improve ventilation and thereby shorten the duration of the respiratory illness.
Read the detailed description
This pilot clinical trial will compare "usual care" to aerosolized Infasurf. The study objective is to determine
- Do bronchiolitis patients tolerate aerosolized Infasurf?
- Does aerosolized Infasurf induce an improvement in respiration?
- If it does how large a dose is required to observe a positive effect?
- Is the positive effect transient, if so what is the range of duration of the effect?
- Does retreatment also result and a positive response?
- Does aerosolized Infasurf result in more rapid sustained improvement? is superior to.
- Conditions
- Bronchiolitis
- Being tested
- Aerosolized Infasurf
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerosolized InfasurfCombination product
Also called Calfactant
Infants randomized to aerosol treatment will receive Infasurf® aerosol at a rate of 12 ml/hour (the maximal rate using the Solaris CAG). The initial treatment will be for 60 minutes, with reevaluation every 30 minutes thereafter, with a maximum dose of 6 mL/Kg body weight or 2 hours of aerosolization. Treatment will be stopped after 60 minutes (and subsequently at 30-minute intervals) if a 2 point reduction in bronchiolitis score or a score ≤ 4 is achieved. Treatment will also be stopped at any time should there be evidence of other-than-transient deterioration in oxygenation or clinical status or for any serious adverse effect deemed by the infant's clinician to be possibly related to the drug administration.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects randomized to the aerosol surfactant evaluation will occur at the end of 60 minutes, with the aerosol continued if the bronchiolitis score is > 4 or there has been less than a 2-point improvement in the bronchiolitis score. Similar evaluation will be performed, if necessary, at 30-minute intervals (maximum 2 hours) with stoppage of the aerosol for an improved bronchiolitis score (≤ 4 or 2-point improvement) at any of the time points. The aerosol would be stopped at any time for significant sustained deterioration in clinical status or any serious adverse event felt related to the treatment. Retreatment can be given at > 4 but < 24 hours if the initial response was positive and there has been subsequent deterioration. Receives: Combination Product: Aerosolized Infasurf |
| Usual Care | No intervention | The only difference in care between treatment and usual care will be treatment with up to two doses of aerosolized Infasurf®. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Respiratory Status
Incidence of positive respiratory response to Infasurf® Aerosol defined as Bronchiolitis Clinical Score decreased by 2 points or to ≤4.
Measured: 24 hours post PICU admission
Secondary outcomes (1)
Need of Respiratory support
Incidence of need for non-invasive (BiPAP, NIV-NAVA) or invasive ventilation
Measured: 24 hours post PICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start12 Jan 2019
- Primary completion2 Oct 2020
- Study completion21 Oct 2020
Why it stopped: slowdown due to covid
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- ONY
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748173
- Sponsor's protocol ID
- Aero-04
- Status last verified
- Oct 2020
- First submitted
- 15 Nov 2018
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04 A Pilot Study of Aerosol Surfactant for Bronchiolitis in Infants
- ClinicalTrials.gov ID
- NCT03748173
- Acronym / sponsor ID
- Aero-04
- Conditions
- Bronchiolitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slowdown due to covid
- Enrolment
- 13 participants (actual)
- Lead sponsor
- ONYIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 20 Nov 2018 (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.
Delivery of aerosolized Infasurf to bronchiolitis patients with who are not on assisted ventilation can provide sufficient delivery of Infasurf to small airways to improve ventilation and thereby shorten the duration of the respiratory illness.
Detailed description
This pilot clinical trial will compare "usual care" to aerosolized Infasurf. The study objective is to determine
- Do bronchiolitis patients tolerate aerosolized Infasurf?
- Does aerosolized Infasurf induce an improvement in respiration?
- If it does how large a dose is required to observe a positive effect?
- Is the positive effect transient, if so what is the range of duration of the effect?
- Does retreatment also result and a positive response?
- Does aerosolized Infasurf result in more rapid sustained improvement? is superior to.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Combination Product: Aerosolized InfasurfSubjects randomized to the aerosol surfactant evaluation will occur at the end of 60 minutes, with the aerosol continued if the bronchiolitis score is > 4 or there has been less than a 2-point improvement in the bronchiolitis score. Similar evaluation will be performed, if necessary, at 30-minute intervals (maximum 2 hours) with stoppage of the aerosol for an improved bronchiolitis score (≤ 4 or 2-point improvement) at any of the time points. The aerosol would be stopped at any time for significant sustained deterioration in clinical status or any serious adverse event felt related to the treatment. Retreatment can be given at > 4 but < 24 hours if the initial response was positive and there has been subsequent deterioration. |
| Usual Care | No intervention | –The only difference in care between treatment and usual care will be treatment with up to two doses of aerosolized Infasurf®. |
Who may qualify
- Ages
- 0 to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infant ≤ 4 months of age admitted to the PICU with the clinical diagnosis of bronchiolitis
- Severe illness as reflected by a bronchiolitis score ≥ 4 and requiring high flow nasal cannula or continuous positive airway pressure for respiratory support
- Within 4 hours of PICU admission.
Key exclusion criteria (9 listed)
- Need for non-invasive BiPAP or invasive ventilation
- Significant Co-morbidities
- Tracheostomy
- Influenza as the etiologic agent of bronchiolitis
- Inability to stabilize the infant to a bronchiolitis score < 8
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 |
|---|---|---|
| Aerosolized InfasurfAlso: CalfactantInfants randomized to aerosol treatment will receive Infasurf® aerosol at a rate of 12 ml/hour (the maximal rate using the Solaris CAG). The initial treatment will be for 60 minutes, with reevaluation every 30 minutes thereafter, with a maximum dose of 6 mL/Kg body weight or 2 hours of aerosolization. Treatment will be stopped after 60 minutes (and subsequently at 30-minute intervals) if a 2 point reduction in bronchiolitis score or a score ≤ 4 is achieved. Treatment will also be stopped at any time should there be evidence of other-than-transient deterioration in oxygenation or clinical status or for any serious adverse effect deemed by the infant's clinician to be possibly related to the drug administration. | Combination product | Treatment |
Primary outcome
Improvement in Respiratory Status
Time frame: 24 hours post PICU admission
Incidence of positive respiratory response to Infasurf® Aerosol defined as Bronchiolitis Clinical Score decreased by 2 points or to ≤4.
1 secondary outcome
Need of Respiratory support
Time frame: 24 hours post PICU admission
Results and safety
The study was stopped early (reason given: slowdown due to covid). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: No
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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 Aerosolized Infasurf in people with Bronchiolitis, run by ONY 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 23 Oct 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 was stopped early (reason given: slowdown due to covid). Results are not available in the source record.
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?
Improvement in Respiratory Status (time frame: 24 hours post PICU admission). 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 23 Oct 2020.