Trial Outcomes & Findings for ARrest RESpiraTory Failure From PNEUMONIA (NCT NCT04193878)
NCT ID: NCT04193878
Last Updated: 2026-08-06
Results Overview
High flow nasal cannula (HFNC \>=20L/mon O2) and/or Noninvasive ventilation (NIV) use for greater than 36 hours OR Invasive mechanical ventilation for greater than 36 hours OR Death in a patient placed on respiratory support (HFNC, NIV, ventilator) who dies before 36 hours
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
465 participants
Primary outcome timeframe
within 7 days of randomization (day 0)
Results posted on
2026-08-06
Participant Flow
Participant milestones
| Measure |
Intervention
Participants receive inhaled budesonide and formoterol: aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days
|
Placebo
Participants receive inhaled placebo: aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days
|
|---|---|---|
|
Overall Study
STARTED
|
235
|
230
|
|
Overall Study
COMPLETED
|
218
|
212
|
|
Overall Study
NOT COMPLETED
|
17
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ARrest RESpiraTory Failure From PNEUMONIA
Baseline characteristics by cohort
| Measure |
Intervention
n=235 Participants
Participants receive inhaled budesonide and formoterol: aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days
|
Placebo
n=230 Participants
Participants receive inhaled placebo: aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days
|
Total
n=465 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 17.4 • n=20 Participants
|
67.9 years
STANDARD_DEVIATION 16.4 • n=20 Participants
|
67.4 years
STANDARD_DEVIATION 16.9 • n=40 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=20 Participants
|
73 Participants
n=20 Participants
|
162 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=20 Participants
|
157 Participants
n=20 Participants
|
303 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
63 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
196 Participants
n=20 Participants
|
195 Participants
n=20 Participants
|
391 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
171 Participants
n=20 Participants
|
159 Participants
n=20 Participants
|
330 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
25 Participants
n=20 Participants
|
27 Participants
n=20 Participants
|
52 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
19 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
16 Participants
n=20 Participants
|
23 Participants
n=20 Participants
|
39 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
235 Participants
n=20 Participants
|
230 Participants
n=20 Participants
|
465 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: within 7 days of randomization (day 0)High flow nasal cannula (HFNC \>=20L/mon O2) and/or Noninvasive ventilation (NIV) use for greater than 36 hours OR Invasive mechanical ventilation for greater than 36 hours OR Death in a patient placed on respiratory support (HFNC, NIV, ventilator) who dies before 36 hours
Outcome measures
| Measure |
Intervention
n=235 Participants
Participants receive inhaled budesonide and formoterol: aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days
|
Placebo
n=230 Participants
Participants receive inhaled placebo: aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days
|
|---|---|---|
|
Acute Respiratory Failure (ARF)
|
47 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: within 60 days of randomization (day 0)Outcome measures
| Measure |
Intervention
n=235 Participants
Participants receive inhaled budesonide and formoterol: aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days
|
Placebo
n=230 Participants
Participants receive inhaled placebo: aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days
|
|---|---|---|
|
Hospital Length of Stay
|
6 days
Interval 3.0 to 12.0
|
6 days
Interval 4.0 to 12.0
|
SECONDARY outcome
Timeframe: within 30 days of randomization (day 0)Outcome measures
| Measure |
Intervention
n=235 Participants
Participants receive inhaled budesonide and formoterol: aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days
|
Placebo
n=230 Participants
Participants receive inhaled placebo: aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days
|
|---|---|---|
|
Duration of Need for Supplemental Oxygen
|
5 days
Interval 2.0 to 16.0
|
5 days
Interval 3.0 to 12.0
|
SECONDARY outcome
Timeframe: Within 7 days of randomization (day 0)Population: Participants who were intubated for respiratory failure.
Outcome measures
| Measure |
Intervention
n=232 Participants
Participants receive inhaled budesonide and formoterol: aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days
|
Placebo
n=228 Participants
Participants receive inhaled placebo: aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days
|
|---|---|---|
|
Proportion of Patients Intubated for Respiratory Failure
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Until Day 28Outcome measures
| Measure |
Intervention
n=235 Participants
Participants receive inhaled budesonide and formoterol: aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days
|
Placebo
n=230 Participants
Participants receive inhaled placebo: aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days
|
|---|---|---|
|
Oxygen Failure Free Days to Day 28
|
23 days
Interval 12.0 to 26.0
|
23 days
Interval 16.0 to 25.0
|
SECONDARY outcome
Timeframe: Within 7 days of randomization (day 0)Population: Analysis of all participants, and participants with COVID.
Progression defined as initiating post-randomization, open-label steroids if not already receiving dexamethasone for COVID at baseline.
Outcome measures
| Measure |
Intervention
n=235 Participants
Participants receive inhaled budesonide and formoterol: aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days
|
Placebo
n=230 Participants
Participants receive inhaled placebo: aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days
|
|---|---|---|
|
Progression to Systemic Steroid Therapy for Pneumonia
Progression to systemic steroid therapy for pneumonia (all randomized)
|
52 Participants
|
46 Participants
|
|
Progression to Systemic Steroid Therapy for Pneumonia
Progression to systemic steroid therapy for pneumonia (COVID patients only)
|
5 Participants
|
8 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 25 deaths
Placebo
Serious events: 7 serious events
Other events: 0 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Intervention
n=235 participants at risk
Participants receive inhaled budesonide and formoterol: aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days
|
Placebo
n=230 participants at risk
Participants receive inhaled placebo: aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days
|
|---|---|---|
|
Cardiac disorders
Asystole
|
0.00%
0/235 • 48 hours after the last dose of study drug (up to 5 days post-randomization) or hospital discharge (if sooner)
As pre-specified in the study protocol, anticipated events that were captured as study endpoints, such as death or acute respiratory failure, were reported as cumulative study endpoints and not as individual SAEs in accordance with FDA guidelines.
|
0.43%
1/230 • 48 hours after the last dose of study drug (up to 5 days post-randomization) or hospital discharge (if sooner)
As pre-specified in the study protocol, anticipated events that were captured as study endpoints, such as death or acute respiratory failure, were reported as cumulative study endpoints and not as individual SAEs in accordance with FDA guidelines.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/235 • 48 hours after the last dose of study drug (up to 5 days post-randomization) or hospital discharge (if sooner)
As pre-specified in the study protocol, anticipated events that were captured as study endpoints, such as death or acute respiratory failure, were reported as cumulative study endpoints and not as individual SAEs in accordance with FDA guidelines.
|
0.43%
1/230 • 48 hours after the last dose of study drug (up to 5 days post-randomization) or hospital discharge (if sooner)
As pre-specified in the study protocol, anticipated events that were captured as study endpoints, such as death or acute respiratory failure, were reported as cumulative study endpoints and not as individual SAEs in accordance with FDA guidelines.
|
|
Cardiac disorders
New atrial fibrillation or other SVT
|
0.00%
0/235 • 48 hours after the last dose of study drug (up to 5 days post-randomization) or hospital discharge (if sooner)
As pre-specified in the study protocol, anticipated events that were captured as study endpoints, such as death or acute respiratory failure, were reported as cumulative study endpoints and not as individual SAEs in accordance with FDA guidelines.
|
0.43%
1/230 • 48 hours after the last dose of study drug (up to 5 days post-randomization) or hospital discharge (if sooner)
As pre-specified in the study protocol, anticipated events that were captured as study endpoints, such as death or acute respiratory failure, were reported as cumulative study endpoints and not as individual SAEs in accordance with FDA guidelines.
|
|
Cardiac disorders
Palpitations and increased heart rate
|
0.00%
0/235 • 48 hours after the last dose of study drug (up to 5 days post-randomization) or hospital discharge (if sooner)
As pre-specified in the study protocol, anticipated events that were captured as study endpoints, such as death or acute respiratory failure, were reported as cumulative study endpoints and not as individual SAEs in accordance with FDA guidelines.
|
0.43%
1/230 • 48 hours after the last dose of study drug (up to 5 days post-randomization) or hospital discharge (if sooner)
As pre-specified in the study protocol, anticipated events that were captured as study endpoints, such as death or acute respiratory failure, were reported as cumulative study endpoints and not as individual SAEs in accordance with FDA guidelines.
|
|
Nervous system disorders
Stroke
|
0.00%
0/235 • 48 hours after the last dose of study drug (up to 5 days post-randomization) or hospital discharge (if sooner)
As pre-specified in the study protocol, anticipated events that were captured as study endpoints, such as death or acute respiratory failure, were reported as cumulative study endpoints and not as individual SAEs in accordance with FDA guidelines.
|
0.43%
1/230 • 48 hours after the last dose of study drug (up to 5 days post-randomization) or hospital discharge (if sooner)
As pre-specified in the study protocol, anticipated events that were captured as study endpoints, such as death or acute respiratory failure, were reported as cumulative study endpoints and not as individual SAEs in accordance with FDA guidelines.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER