Trial · NCT00124176
Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
NCT00124176, Phase 4, Completed, Children's Hospital of Philadelphia; results first posted 2013-03-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Continuous Levalbuterol for Treatment of Status Asthmaticus in Children. Trials, record NCT00124176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00124176
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
- NCT number
- NCT00124176
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 81 participants, actual
- Lead sponsor
- Children's Hospital of Philadelphia
- Conditions
- Asthma
- Interventions
- Racemic albuterol (R+S albuterol), Levalbuterol (R albuterol)
- First posted
- 2005-07-27
- Last updated
- 2013-03-14
- Results first posted
- 2013-03-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Continuous Therapy | During hospitalization | standard intention to treat (ITT) analysis |
| Secondary | Change in Pediatric Asthma Severity Score | After 12 hours of continuous nebulization | Change in Pediatric Asthma Severity Score. Range 0 (best) - 6 (worst) Score at each time point is calculated by adding 3 elements: Wheeze (0= None/Mild, 1=Moderate, 2=Severe) Prolonged expiration (0= None/Mild, 1=Moderate, 2=Severe) Work of breathing (0= None/Mild, 1=Moderate, 2=Severe) |
| Secondary | Heart Rate | After 12 hours of continuous nebulization | |
| Secondary | Serum Potassium Levels | After 12 hours of continuous nebulization | |
| Secondary | Serum Albuterol S Isomer Levels | After 6 hours of continuous albuterol |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration of Continuous Therapy | During hospitalization | Hours | MEDIAN | |
| SECONDARY | Change in Pediatric Asthma Severity Score | After 12 hours of continuous nebulization | units on a scale | MEAN | |
| SECONDARY | Heart Rate | After 12 hours of continuous nebulization | beats per minute | MEAN | |
| SECONDARY | Serum Potassium Levels | After 12 hours of continuous nebulization | mg/dL | MEAN | |
| SECONDARY | Serum Albuterol S Isomer Levels | After 6 hours of continuous albuterol | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Continuous Therapy | Continuous Levalbuterol (R) Nebulized Solution | 18.3 | Inter-Quartile Range 11 to 25 | Hours | |
| Duration of Continuous Therapy | Continuous Racemic (R+S) Albuterol | 16 | Inter-Quartile Range 11 to 25 | Hours | |
| Change in Pediatric Asthma Severity Score | Continuous Levalbuterol (R) Nebulized Solution | -1.0 | Standard Deviation 1.2 | units on a scale | |
| Change in Pediatric Asthma Severity Score | Continuous Racemic (R+S) Albuterol | -0.64 | Standard Deviation 1.7 | units on a scale | |
| Heart Rate | Continuous Levalbuterol (R) Nebulized Solution | 132 | Standard Deviation 16.4 | beats per minute | |
| Heart Rate | Continuous Racemic (R+S) Albuterol | 132 | Standard Deviation 18.4 | beats per minute | |
| Serum Potassium Levels | Continuous Levalbuterol (R) Nebulized Solution | 3.6 | Standard Deviation 0.6 | mg/dL | |
| Serum Potassium Levels | Continuous Racemic (R+S) Albuterol | 3.6 | Standard Deviation 0.4 | mg/dL | |
| Serum Albuterol S Isomer Levels | Continuous Levalbuterol (R) Nebulized Solution | 5.5 | Standard Deviation 3.3 | ng/mL | |
| Serum Albuterol S Isomer Levels | Continuous Racemic (R+S) Albuterol | 28.6 | Standard Deviation 11.7 | ng/mL |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Continuous Levalbuterol (R) Nebulized Solution | 40 | |
| Overall Study | STARTED | Continuous Racemic (R+S) Albuterol | 41 | |
| Overall Study | Received Study Drug | Continuous Levalbuterol (R) Nebulized Solution | 37 | |
| Overall Study | Received Study Drug | Continuous Racemic (R+S) Albuterol | 41 | |
| Overall Study | COMPLETED | Continuous Levalbuterol (R) Nebulized Solution | 40 | |
| Overall Study | COMPLETED | Continuous Racemic (R+S) Albuterol | 41 | |
| Overall Study | NOT COMPLETED | Continuous Levalbuterol (R) Nebulized Solution | 0 | |
| Overall Study | NOT COMPLETED | Continuous Racemic (R+S) Albuterol | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Continuous Levalbuterol (R) Nebulized Solution | ||
| Total, all-cause mortality | Continuous Racemic (R+S) Albuterol | ||
| Total, other adverse events | Continuous Levalbuterol (R) Nebulized Solution | 0 | 40 |
| Total, other adverse events | Continuous Racemic (R+S) Albuterol | 0 | 41 |
| Total, serious adverse events | Continuous Levalbuterol (R) Nebulized Solution | 0 | 40 |
| Total, serious adverse events | Continuous Racemic (R+S) Albuterol | 0 | 41 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Continuous Levalbuterol (R) Nebulized Solution vs Continuous Racemic (R+S) Albuterol: 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/NCT00124176
GET https://conductscience.org/api/trials/v1/NCT00124176/registered