Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01783821 · ClinicalTrials.gov registry record · Phase 2
LIPS-B: Lung Injury Prevention Study With Budesonide and Beta
A Phase 2 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT01783821: Completed Phase 2 study, sponsored by Mayo Clinic.
NCT01783821 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01783821, a Phase 2 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
This study tested whether inhaled budesonide and formoterol were able to alleviate or prevent pulmonary injury when administered early in hospital course to the patients at risk for developing acute respiratory distress syndrome (ARDS). The FDA has approved many uses for budesonide and formoterol, including asthma and chronic obstructive pulmonary disease (COPD), but the use of these two drugs is experimental for ARDS.
Primary Outcome
Oxygen saturation (SpO2) was measured by pulse oximetry. FiO2 is the assumed proportion of oxygen concentration participating in gas exchange in the alveoli. All S/F measurements were performed per standard operating protocol using a Venturi mask titrated to obtain an oxygen saturation of 94 ± 2% unless the patient met this goal on room air or clinical status dictated an alternative delivery mode. This outcome measure was analyzed as a longitudinal continuous variable by a mixed effect model. Th
Interventions
- DRUG Placebo
- DRUG Budesonide
- DRUG Formoterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT01783821 record still lists
NCT01783821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01783821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01783821 about?
NCT01783821 is a clinical study titled "LIPS-B: Lung Injury Prevention Study With Budesonide and Beta". This study tested whether inhaled budesonide and formoterol were able to alleviate or prevent pulmonary injury when administered early in hospital course to the patients at risk for developing acute respiratory distress syndrome (ARDS). The FDA has approved many uses for budesonide and formoterol, i...
What is the current status of trial NCT01783821?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2013-07. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01783821?
The interventions under investigation include: Placebo (DRUG), Budesonide (DRUG), Formoterol (DRUG).
Who is sponsoring clinical trial NCT01783821?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01783821's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04115306 · 61 participants · Phase 1
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
- NCT05070845 · 61 participants · Phase 2
Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
- NCT05187832 · 61 participants · Phase 1
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
- NCT05269316 · 61 participants · Phase 1
Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia