Acute Respiratory Distress SyndromePhase 2NCT04064684

Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome

A Phase 2 study testing Budesonide and Nebulizer in people with Acute Respiratory Distress Syndrome, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 30 days to 18 years
Conditions the study is for: Acute Respiratory Distress Syndrome
What is being tested?: Budesonide and Nebulizer
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 4 Feb 2020to 30 Mar 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 days to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Pediatric patients older than 30 days and up to 18 years of age admitted to the PICU with a diagnosis of PARDS enrolled within 72 hours of diagnosis.
Patients requiring invasive mechanical ventilation.
Criteria of PARDS as defined by the Pediatric Acute Lung Injury Consensus Conference (PALICC), on June 2015 in Pediatric Critical Care Journal

Who cannot join

Patients with diffuse alveolar hemorrhage.
Patients terminally ill with limitation of care or in hospice care.
Patients receiving inhaled steroids or systemic steroids as chronic therapy before admission.
Patients with high dose systemic steroids for anti-inflammatory purposes. The investigators will not exclude patients receiving hydrocortisone for shock.

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome (PARDS), a Randomized Pilot Trial

The purpose of this study is to show that inhaled steroids in patient with PARDS can decrease the days on mechanical ventilator measured by ventilator-free days,to improve the oxygenation index (OI) or oxygenation saturation index (OSI) in patients receiving inhaled steroids and to show the relevance and feasibility of a larger study by assessing the hypothesis in a small cohort of patients. Patient will be treated for a maximum of 10 days. Secondary objectives are to reduce the length of stay (LOS) in the pediatric intensive care unit (PICU) and hospital admissions; to show less inflammation in the patients receiving inhaled steroids by measuring inflammatory markers from tracheal aspirates like Interleukin (IL6, IL8, tumor necrosis factor (TNF) α, matrix metalloproteinase8 (MMP8) and matrix metalloproteinase9 (MMP9). Lastly, to show that inhaled steroids can improve residual lung disease evaluated by Pulmonary Function Test (PFTs) and Impulse Oscillometry (IOS).

Conditions: Acute Respiratory Distress Syndrome
Being tested: Budesonide, Placebo, Nebulizer
Keywords: Pediatric acute respiratory distress syndrome, PARDS, Budesonide, inhaled steroids
Medical subject headings: Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BudesonideDrug
Also called Pulmicort Respules®
Enrolled patients will be treated with Pulmicort Respules® (Budesonide inhalation suspension), at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator. The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.
PlaceboDrug
Enrolled patients will be treated with normal saline.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.
NebulizerDevice
The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.

Study groups in NCT04064684
Study group	Role	What they receive
Budesonide administered by nebulizer	Experimental	Not described Receives: Drug: Budesonide; Device: Nebulizer
Placebo administered by nebulizer	Placebo comparator	Not described Receives: Drug: Placebo; Device: Nebulizer

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Ventilator-free Days (VFD)
Measured: Between the time of enrollment and day 28 after enrollment

Secondary outcomes (29)

Oxygenation Index (OI)
Oxygenation index (OI) is calculated as ([FiO2 x Mean Airway Pressure] / PaO2). FiO2 stands for inspired fraction of oxygen, and PaO2 stands for pressure/arterial pressure of oxygen. An oxygenation index of 4-8 indicates mild ARDS, an oxygenation index of 8-16 indicates moderate ARDS, and an oxygenation index greater than 16 indicates severe ARDS.
Measured: Day one to last day of last day of mechanical ventilation (up to 10 days)
Oxygen Saturation Index (OSI)
5-7.5 mild ARDS, 7.5-12.3 moderate ARDS. > 12.3 severe ARDS, formula FiO2*Mean airway pressure/Saturation of O2
Oxygen saturation index (OI) is calculated as ([FiO2 x Mean Airway Pressure] / Saturation of oxygen). FiO2 stands for inspired fraction of oxygen. An oxygen saturation index of 5-7.5 indicates mild ARDS, an oxygen saturation index of 7.5-12.3 indicates moderate ARDS, and an oxygen saturation index greater than 12.3 indicates severe ARDS.
Measured: Day one to last day of last day of mechanical ventilation up to 28 days since enrollment
Number of Days Participant Stayed in Pediatric Intensive Care Unit (PICU)
Measured: from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)
Number of Days Participant Stayed in Hospital
Measured: from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)
TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: Day 1
TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: Day 3
TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
Interleukin (IL) -6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: Day 1
IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: Day 3
IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: Day 1
IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: Day 3
IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: Day 1
MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: Day 3
MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: Day 1
MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: Day 3
MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Measured: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
Neutrophil Count
Measured: Day 1
Neutrophil Count
Measured: Day 3
Neutrophil Count
Measured: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
FEV1
Forced expiration in 1st second, abnormal (obstructive)<80% L/second
Measured: 90 days since first day of treatment
Forced Expiratory Volume at One Second FEV1/FVC
Restrictive disease if <70%
Measured: 90 days since first day of treatment
Forced Vital Capacity (FVC)
<80% restrictive lung disease, L
Measured: 90 days since first day of treatment
Forced Expiratory Flow FEF 25-75%
Medium size bronchioles, normal 60-130%
Measured: 90 days since first day of treatment
Respiratory Resistance by Impulse Oscillometry (IOS)
Rrs 3-35 Hz
Measured: 90 days since first day of treatment
Respiratory Impedance by Impulse Oscillometry (IOS)
Zrs 3-35 Hz
Measured: 90 days since first day of treatment
Respiratory Reactance by Impulse Oscillometry (IOS)
Xrs 3-35 Hz
Measured: 90 days since first day of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 202030 Mar 2020

First posted22 Aug 2019
Study start4 Feb 2020
Primary completion30 Mar 2020
Study completion30 Mar 2020

Why it stopped: Enrollment difficulties after the start of the COVID-19 pandemic.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04064684
Sponsor's protocol ID: HSC-MS-19-0566
Other IDs: KL2TR003168
Status last verified: Jun 2022
First submitted: 16 Aug 2019
Last updated: 13 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
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All Acute Respiratory Distress Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome (PARDS), a Randomized Pilot Trial
ClinicalTrials.gov ID: NCT04064684
Acronym / sponsor ID: HSC-MS-19-0566
Conditions: Acute Respiratory Distress Syndrome
Keywords: Pediatric acute respiratory distress syndrome, PARDS, Budesonide, inhaled steroids
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Enrollment difficulties after the start of the COVID-19 pandemic.
Enrolment: 2 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 4 Feb 2020 (actual)
Primary completion: 30 Mar 2020 (actual)
Study completion: 30 Mar 2020 (actual)
First posted: 22 Aug 2019 (actual)
Results: Posted 31 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Budesonide administered by nebulizer	Experimental	Drug: Budesonide, Device: Nebulizer
Placebo administered by nebulizer	Placebo comparator	Drug: Placebo, Device: Nebulizer

Who may qualify

Ages: 30 days to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Pediatric patients older than 30 days and up to 18 years of age admitted to the PICU with a diagnosis of PARDS enrolled within 72 hours of diagnosis.
Patients requiring invasive mechanical ventilation.
Criteria of PARDS as defined by the Pediatric Acute Lung Injury Consensus Conference (PALICC), on June 2015 in Pediatric Critical Care Journal

Key exclusion criteria (4 listed)

Patients with diffuse alveolar hemorrhage.
Patients terminally ill with limitation of care or in hospice care.
Patients receiving inhaled steroids or systemic steroids as chronic therapy before admission.
Patients with high dose systemic steroids for anti-inflammatory purposes. The investigators will not exclude patients receiving hydrocortisone for shock.

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
BudesonideAlso: Pulmicort Respules®Enrolled patients will be treated with Pulmicort Respules® (Budesonide inhalation suspension), at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator. The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.	Drug	Budesonide administered by nebulizer
PlaceboEnrolled patients will be treated with normal saline.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.	Drug	Placebo administered by nebulizer
NebulizerThe medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.	Device	Budesonide administered by nebulizer, Placebo administered by nebulizer

Primary outcome

Number of Ventilator-free Days (VFD)
Time frame: Between the time of enrollment and day 28 after enrollment

29 secondary outcomes

Oxygenation Index (OI)
Time frame: Day one to last day of last day of mechanical ventilation (up to 10 days)
Oxygen Saturation Index (OSI)
Time frame: Day one to last day of last day of mechanical ventilation up to 28 days since enrollment
Number of Days Participant Stayed in Pediatric Intensive Care Unit (PICU)
Time frame: from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)
Number of Days Participant Stayed in Hospital
Time frame: from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)
TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 1
TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 3
TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
Interleukin (IL) -6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 1
IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 3
IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 1
IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 3
IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 1
MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 3
MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 1
MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 3
MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
Neutrophil Count
Time frame: Day 1
Neutrophil Count
Time frame: Day 3
Neutrophil Count
Time frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
FEV1
Time frame: 90 days since first day of treatment
Forced Expiratory Volume at One Second FEV1/FVC
Time frame: 90 days since first day of treatment
Forced Vital Capacity (FVC)
Time frame: 90 days since first day of treatment
Forced Expiratory Flow FEF 25-75%
Time frame: 90 days since first day of treatment
Respiratory Resistance by Impulse Oscillometry (IOS)
Time frame: 90 days since first day of treatment
Respiratory Impedance by Impulse Oscillometry (IOS)
Time frame: 90 days since first day of treatment
Respiratory Reactance by Impulse Oscillometry (IOS)
Time frame: 90 days since first day of treatment

Results and safety

Results posted to the registry on 31 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Budesonide Administered by Nebulizer	1	1
Placebo Administered by Nebulizer	1	1

Primary outcome: Number of Ventilator-free Days (VFD)

Time frame: Between the time of enrollment and day 28 after enrollment. Number. Unit: days

Measure	Budesonide Administered by Nebulizer n = 1	Placebo Administered by Nebulizer n = 1
Value	20	17

29 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Budesonide Administered by Nebulizer	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Placebo Administered by Nebulizer	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): Enrollment difficulties after start of the COVID-19 pandemic leading to small sample size

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Alvaro J Coronado Munoz, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Budesonide and Nebulizer in people with Acute Respiratory Distress Syndrome, run by The University of Texas Health Science Center, Houston 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 4 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 13 Jul 2022. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Ventilator-free Days (VFD) (time frame: Between the time of enrollment and day 28 after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04064684.

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 13 Jul 2022.