Trial · NCT00434993
Drug Study of Albuterol to Treat Acute Lung Injury
NCT00434993, Phase 2, Phase 3, Terminated, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2013-07-15
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ConductScience Library. Drug Study of Albuterol to Treat Acute Lung Injury. Trials, record NCT00434993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00434993
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug Study of Albuterol to Treat Acute Lung Injury
- NCT number
- NCT00434993
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 282 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Respiratory Distress Syndrome, Adult
- Interventions
- Albuterol Sulfate, Mini-Bronchoalveolar Lavage (BAL), Placebo
- First posted
- 2007-02-14
- Last updated
- 2017-02-10
- Results first posted
- 2013-07-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Ventilator Free Days (VFD) | Determined 28 days after a subject entered the study | Ventilator-free days (VFDs) is defined as the number of days from randomization to Day 28 after achieving unassisted breathing for patients who maintained unassisted breathing for at least two consecutive calendar days. If a patient achieved unassisted breathing, subsequently required additional assisted breathing, and once again achieved unassisted breathing, we counted only the VFDs after beginning the final period of unassisted breathing. Patients who died before Day 28 were assigned zero VFDs. |
| Secondary | Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 60 | Determined 60 days after a subject entered the study | Success for this efficacy variable was defined as being alive on study day 60 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those subjects alive in hospital at day 60 were considered to have survived. |
| Secondary | Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 90 | Determined 90 days after a subject entered the study | Success for this efficacy variable was defined as being alive on study day 90 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those participants who still remained in the hospital at 90 days after randomization were considered to have survived. |
| Secondary | Number of ICU-free Days at 28 Days After Randomization | Determined 28 days after a subject entered the study | ICU (intensive care unit)-free days was defined as the number of days a subject was out of the ICU during study hospitalization from date of randomization up to study day 28. All incidences of ICU admission and discharge during the study hospitalization were captured. Any portion of a calendar day that a subject was in the ICU was counted as an ICU day. |
| Secondary | Number of Organ Failure-free Days at Day 28 Following Randomization | Daily from baseline to study day 28 | Subjects were followed for development of organ failures from date of randomization to hospital discharge or study day 28, whichever was first. Organ failure was defined as present on any calendar day when the most abnormal vital signs or clinically available lab value met the definition of clinically significant organ failure according to the Brussels Organ Failure Table. Each day a patient was alive and free of a given clinically significant organ failure was scored as a failure-free day. The worst value for a calendar day was captured (lowest systolic BP, platelet count and highest creatinine and bilirubin values). Specific definitions of organ failure were: cardiovascular-systolic BP less than or equal to 90 mmHg or on a vasopressor; coagulation-platelet count less than or equal to 80 x 1000/mm3; Renal-creatinine less than or equal to 2.0 mg/dL; Hepatic-bilirubin less than or equal to 2.0 mg/dL. |
| Secondary | Ventilator Free Days to Day 28 in the Subset of Participants With ARDS | Determined 28 days after a subject entered the study | Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200). P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2. VFD to Day 28 is defined as the number of days from the end of ventilation to day 28 in patients who maintained unassisted breathing for at least two consecutive calendar days. Patients who died before day 28 were assigned a VFD count of zero. If a patient returned to assisted breathing, subsequently required assisted breathing, and once again achieved unassisted breathing, only the VFDs after beginning the final period of unassisted breathing were counted. An increase in the number of VFDs was considered a positive result. |
| Secondary | Hospital Mortality to Day 60 in the Subset of Participants With ARDS | Determined 60 days after a subject entered the study | Difference in the main outcome mortality to study day 60 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200) prior to randomization. P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2. |
| Secondary | Ventilator Free Days to Day 28 in the Subset of Patients With Baseline Shock | Determined 28 days after a subject entered the study | Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure\<60 or the need for vasopressors (except dopamine \<6 ug/kg/min). |
| Secondary | Hospital Mortality up to Day 60 in Subjects With Baseline Shock | Determined 60 days after a subject entered the study | Difference in the main outcome hospital mortality to study day 60 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure\<60 or the need for vasopressors (except dopamine \<6 ug/kg/min). |
| Secondary | Plasma Levels of IL-6 and IL-8 on Study Day 3 | Measured at baseline and 3 days after randomization | Biologic end-points were selected that would provide mechanistic insight into how albuterol improved lung function. Concentrations of two proinflammatory cytokines, interleukin 6 and 8 (IL-6 and IL-8), were measured. Plasma was collected and cytokine levels were measured at baseline and 3 days after randomization. IL-6 and IL-8 levels were normalized using log transformation. Wilcoxon's test was used to compare mean log-transformed interleukin levels per day and a mixed-effects model was fit to compare the slopes. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Ventilator Free Days (VFD) | Determined 28 days after a subject entered the study | All the intent to treat patients were analyzed. Data was available on all subjects for the primary analysis only. | days | MEAN |
| SECONDARY | Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 60 | Determined 60 days after a subject entered the study | Intent to treat population. | percentage of participants who died | NUMBER |
| SECONDARY | Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 90 | Determined 90 days after a subject entered the study | Intent to treat. | percentage of participants who died | NUMBER |
| SECONDARY | Number of ICU-free Days at 28 Days After Randomization | Determined 28 days after a subject entered the study | Intent to treat. | days | MEAN |
| SECONDARY | Number of Organ Failure-free Days at Day 28 Following Randomization | Daily from baseline to study day 28 | Intent to treat. | days | MEAN |
| SECONDARY | Ventilator Free Days to Day 28 in the Subset of Participants With ARDS | Determined 28 days after a subject entered the study | Patients meeting the criteria for ARDS (pre-randomization PaO2/FiO2 ratio less than or equal to 200) were selected for this subset. | days | MEAN |
| SECONDARY | Hospital Mortality to Day 60 in the Subset of Participants With ARDS | Determined 60 days after a subject entered the study | Patients meeting the criteria for ARDS (pre-randomization PaO2/FiO2 ratio less than or equal to 200) were selected for this subset. | percentage of participants who died | NUMBER |
| SECONDARY | Ventilator Free Days to Day 28 in the Subset of Patients With Baseline Shock | Determined 28 days after a subject entered the study | Patients with protocol defined shock (mean arterial pressure\<60 or need for vasopressors except dopamine \< 6ug/kg/min) at the time of study entry. | days | MEAN |
| SECONDARY | Hospital Mortality up to Day 60 in Subjects With Baseline Shock | Determined 60 days after a subject entered the study | Patients with protocol defined shock (mean arterial pressure\<60 or need for vasopressors except dopamine \< 6ug/kg/min) at the time of study entry. | percentage of participants who died | NUMBER |
| SECONDARY | Plasma Levels of IL-6 and IL-8 on Study Day 3 | Measured at baseline and 3 days after randomization | Not all subjects had available data for secondary analyses and therefor the numbers will be less than the 152 (active) and 130 (placebo) arms. | pg/ml | LOG_MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Ventilator Free Days (VFD) | Albuterol | 14.4 | Standard Error 0.9 | days | |
| Number of Ventilator Free Days (VFD) | Placebo | 16.6 | Standard Error 0.9 | days | |
| Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 60 | Albuterol | 23.0 | percentage of participants who died | ||
| Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 60 | Placebo | 17.7 | percentage of participants who died | ||
| Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 90 | Albuterol | 24.3 | percentage of participants who died | ||
| Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 90 | Placebo | 18.5 | percentage of participants who died | ||
| Number of ICU-free Days at 28 Days After Randomization | Albuterol | 13.5 | Standard Error 0.8 | days | |
| Number of ICU-free Days at 28 Days After Randomization | Placebo | 16.2 | Standard Error 0.8 | days | |
| Number of Organ Failure-free Days at Day 28 Following Randomization | Albuterol | 14.2 | Standard Error 0.9 | days | |
| Number of Organ Failure-free Days at Day 28 Following Randomization | Placebo | 15.9 | Standard Error 1.0 | days |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Albuterol Sulfate | 152 | |
| Overall Study | STARTED | Placebo | 130 | |
| Overall Study | COMPLETED | Albuterol Sulfate | 152 | |
| Overall Study | COMPLETED | Placebo | 130 | |
| Overall Study | NOT COMPLETED | Albuterol Sulfate | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arrhythmias (clinically important) | Cardiac disorders | Albuterol Sulfate | 15 | 152 | 29 |
| other | Arrhythmias (clinically important) | Cardiac disorders | Placebo | 8 | 130 | 11 |
| other | Hypokalemia | Metabolism and nutrition disorders | Albuterol Sulfate | 8 | 152 | 12 |
| other | Hypokalemia | Metabolism and nutrition disorders | Placebo | 7 | 130 | 13 |
| serious | Hypoxemia | Respiratory, thoracic and mediastinal disorders | Albuterol Sulfate | 0 | 152 | 0 |
| serious | Hypoxemia | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 130 | 1 |
| serious | Hypoxia | Respiratory, thoracic and mediastinal disorders | Albuterol Sulfate | 1 | 152 | 1 |
| serious | Hypoxia | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 130 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Albuterol Sulfate | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Albuterol Sulfate | 21 | 152 |
| Total, other adverse events | Placebo | 15 | 130 |
| Total, serious adverse events | Albuterol Sulfate | 1 | 152 |
| Total, serious adverse events | Placebo | 1 | 130 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| N01HR056179 | Clin Coord Ctr for Clin Ntwrk Treatment of ARDS-268056179-268056179 | SCHOENFELD, DAVID | MASSACHUSETTS GENERAL HOSPITAL | DIVISION OF LUNG DISEASES | 2005 to 2006 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Albuterol Sulfate vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00434993
GET https://conductscience.org/api/trials/v1/NCT00434993/results?page=2