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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04064684
• Collaborator: National Center for Advancing Translational Science (NCATS) (NIH)
• Enrollment: 2
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.8
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome	Drug: Budesonide; Drug: Placebo; Device: Nebulizer	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome (PARDS), a Randomized Pilot Trial
• Actual Study Start Date: Feb 4, 2020
• Actual Primary Completion Date: Mar 30, 2020
• Actual Study Completion Date: Mar 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Budesonide administered by nebulizer	Drug: Budesonide; 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.; Other Names: Pulmicort Respules® ; Device: Nebulizer; 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.
Placebo Comparator: Placebo administered by nebulizer	Drug: Placebo; 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.; Device: Nebulizer; 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.

Outcome Measures

Primary Outcome Measures

1. Number of Ventilator-free Days (VFD) [Between the time of enrollment and day 28 after enrollment]

Secondary Outcome Measures

1. Oxygenation Index (OI) [Day one to last day of last day of mechanical ventilation (up to 10 days)]

   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.

2. Oxygen Saturation Index (OSI) [Day one to last day of last day of mechanical ventilation up to 28 days since enrollment]

   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.

3. Number of Days Participant Stayed in Pediatric Intensive Care Unit (PICU) [from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)]

4. Number of Days Participant Stayed in Hospital [from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)]

5. TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [Day 1]

6. TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [Day 3]

7. TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [last day of treatment or last day of invasive mechanical ventilation( upto day 28)]

8. Interleukin (IL) -6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [Day 1]

9. IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [Day 3]

10. IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [last day of treatment or last day of invasive mechanical ventilation( upto day 28)]

11. IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [Day 1]

12. IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [Day 3]

13. IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [last day of treatment or last day of invasive mechanical ventilation( upto day 28)]

14. MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [Day 1]

15. MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [Day 3]

16. MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [last day of treatment or last day of invasive mechanical ventilation( upto day 28)]

17. MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [Day 1]

18. MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [Day 3]

19. MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test [last day of treatment or last day of invasive mechanical ventilation( upto day 28)]

20. Neutrophil Count [Day 1]

21. Neutrophil Count [Day 3]

22. Neutrophil Count [last day of treatment or last day of invasive mechanical ventilation( upto day 28)]

23. FEV1 [90 days since first day of treatment]

    Forced expiration in 1st second, abnormal (obstructive)<80% L/second

24. Forced Expiratory Volume at One Second FEV1/FVC [90 days since first day of treatment]

    Restrictive disease if <70%

25. Forced Vital Capacity (FVC) [90 days since first day of treatment]

    <80% restrictive lung disease, L

26. Forced Expiratory Flow FEF 25-75% [90 days since first day of treatment]

    Medium size bronchioles, normal 60-130%

27. Respiratory Resistance by Impulse Oscillometry (IOS) [90 days since first day of treatment]

    Rrs 3-35 Hz

28. Respiratory Impedance by Impulse Oscillometry (IOS) [90 days since first day of treatment]

    Zrs 3-35 Hz

29. Respiratory Reactance by Impulse Oscillometry (IOS) [90 days since first day of treatment]

    Xrs 3-35 Hz

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Days to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston
• National Center for Advancing Translational Science (NCATS)

Investigators

• Principal Investigator: Alvaro J Coronado Munoz, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 16, 2019
• Informed Consent Form - Aug 15, 2019

More Information

Publications

None provided.

• Responsible Party: Alvaro J Coronado Munoz, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT04064684
• Other Study ID Numbers: HSC-MS-19-0566; KL2TR003168
• First Posted: Aug 22, 2019
• Last Update Posted: Jul 13, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Alvaro J Coronado Munoz, Assistant Professor, The University of Texas Health Science Center, Houston: Pediatric acute respiratory distress syndrome; PARDS; Budesonide; inhaled steroids
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome; Budesonide

Study Results

Participant Flow

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Period Title: Overall Study
STARTED	1	1
COMPLETED	1	1
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer	Total
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.	Total of all reporting groups
Overall Participants	1	1	2
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	6 (0)	4 (0)	5 (1.4)
Sex: Female, Male (Count of Participants)
Female	0 0%	1 100%	1 50%
Male	1 100%	0 0%	1 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 100%	1 100%	2 100%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%	1 100%	2 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	1	1
Number [days]	20	17

2. Secondary Outcome

Title	Oxygenation Index (OI)
Description	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.
Time Frame	Day one to last day of last day of mechanical ventilation (up to 10 days)

Outcome Measure Data

Analysis Population Description

For the participant in the budesonide arm, data for this outcome measure was not collected on days 9 and 10.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	1	1
day 1	11 (0)	12 (0)
day 2	11 (0)	8 (0)
day 3	8 (0)	11.4 (0)
day 4	4 (0)	6.4 (0)
day 5	3.2 (0)	14.4 (0)
day 6	3.5 (0)	11.5 (0)
day 7	5 (0)	10 (0)
day 8	2.8 (0)	8.7 (0)
day 9	5 (0)
day 10	5 (0)

3. Secondary Outcome

Title	Oxygen Saturation Index (OSI)
Description	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.
Time Frame	Day one to last day of last day of mechanical ventilation up to 28 days since enrollment

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for either participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

4. Secondary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	1	1
Number [days]	46	17

5. Secondary Outcome

Title	Number of Days Participant Stayed in Hospital
Time Frame	from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	1	1
Number [days]	46	23

6. Secondary Outcome

Title	TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

7. Secondary Outcome

Title	TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

8. Secondary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

9. Secondary Outcome

Title	Interleukin (IL) -6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

10. Secondary Outcome

Title	IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

11. Secondary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

12. Secondary Outcome

Title	IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

13. Secondary Outcome

Title	IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

14. Secondary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

15. Secondary Outcome

Title	MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

16. Secondary Outcome

Title	MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

17. Secondary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

18. Secondary Outcome

Title	MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

19. Secondary Outcome

Title	MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

20. Secondary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

21. Secondary Outcome

Title	Neutrophil Count
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

22. Secondary Outcome

Title	Neutrophil Count
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

23. Secondary Outcome

Title	Neutrophil Count
Time Frame	last day of treatment or last day of invasive mechanical ventilation( upto day 28)

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

24. Secondary Outcome

Title	FEV1
Description	Forced expiration in 1st second, abnormal (obstructive)<80% L/second
Time Frame	90 days since first day of treatment

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

25. Secondary Outcome

Title	Forced Expiratory Volume at One Second FEV1/FVC
Description	Restrictive disease if <70%
Time Frame	90 days since first day of treatment

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

26. Secondary Outcome

Title	Forced Vital Capacity (FVC)
Description	<80% restrictive lung disease, L
Time Frame	90 days since first day of treatment

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

27. Secondary Outcome

Title	Forced Expiratory Flow FEF 25-75%
Description	Medium size bronchioles, normal 60-130%
Time Frame	90 days since first day of treatment

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

28. Secondary Outcome

Title	Respiratory Resistance by Impulse Oscillometry (IOS)
Description	Rrs 3-35 Hz
Time Frame	90 days since first day of treatment

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

29. Secondary Outcome

Title	Respiratory Impedance by Impulse Oscillometry (IOS)
Description	Zrs 3-35 Hz
Time Frame	90 days since first day of treatment

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

30. Secondary Outcome

Title	Respiratory Reactance by Impulse Oscillometry (IOS)
Description	Xrs 3-35 Hz
Time Frame	90 days since first day of treatment

Outcome Measure Data

Analysis Population Description

Data for this outcome measure were not collected for any participant.

Arm/Group Title	Budesonide Administered by Nebulizer	Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.	Placebo: 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. Nebulizer: 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.
Measure Participants	0	0

Adverse Events

Time Frame	28 days
Arm/Group Title	Budesonide Administered by Nebulizer		Placebo Administered by Nebulizer
Arm/Group Description	Budesonide: 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. Nebulizer: 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.		Placebo: 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. Nebulizer: 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.
All Cause Mortality
	Budesonide Administered by Nebulizer		Placebo Administered by Nebulizer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)
Serious Adverse Events
	Budesonide Administered by Nebulizer		Placebo Administered by Nebulizer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Budesonide Administered by Nebulizer		Placebo Administered by Nebulizer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)

Limitations/Caveats

Enrollment difficulties after start of the COVID-19 pandemic leading to small sample size

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.