Trial · NCT00583778
A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation
NCT00583778, Not applicable, Completed, MetroHealth Medical Center; results first posted 2022-05-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation. Trials, record NCT00583778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00583778
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation
- NCT number
- NCT00583778
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 141 participants, actual
- Lead sponsor
- MetroHealth Medical Center
- Conditions
- Asthma
- Interventions
- ipratropium
- First posted
- 2007-12-31
- Last updated
- 2022-05-16
- Results first posted
- 2022-05-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Bronchodilation | FEV-1 measured Immediately before treatment dose 1 & 60 minutes after completion of treatment dose 3. Assessment of relapse or recurrence were determined at day 14 after the ED visit. | Measure FEV-1 in participants immediately prior to treatment and 60 minutes after final treatment to determine improvement in bronchodilation after 1.25mg nebulized levalbuterol + 0.5mg nebulized ipratropium administered every 20 minutes for a total of 3 doses versus bronchodilation after 1.25mg nebulized levalbuterol administered every 20 minutes for a total of 3 doses. FEV-1 measurements were obtained using a hand held spirometer. A difference in 12% of median FEV-1 measures between the two groups was considered clinically significant. Patients were called 14 days after their ED visit to assess relapse or recurrence of acute asthma exacerbation. In addition, a chart review was performed to assess relapse or recurrence of acute asthma exacerbation, as well as determine hospital length of stay in those patients who required admission after the initial visit. |
| Primary | Change in FEV-1 % Predicted Over Time | 60 minutes | Primary Outcome- the difference in FEV-1at 60 minutes between participants who received Levalbuterol 1.25 mg x 3 vs participants who received Levalbuterol 1.25 mg x3 + Ipratropium 0.5 mg x3 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Bronchodilation | FEV-1 measured Immediately before treatment dose 1 & 60 minutes after completion of treatment dose 3. Assessment of relapse or recurrence were determined at day 14 after the ED visit. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Change in FEV-1 % Predicted Over Time | 60 minutes | Overall Number of Participants Analyzed 141 | percentage of FEV-1 predicted | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Bronchodilation | Levalbuterol | 74 | Participants | ||
| Number of Participants With Bronchodilation | Levalbuterol Plus Ipratropium | 67 | Participants | ||
| Change in FEV-1 % Predicted Over Time | Levalbuterol | 45 | Inter-Quartile Range 37 to 58 | percentage of FEV-1 predicted | |
| Change in FEV-1 % Predicted Over Time | Levalbuterol Plus Ipratropium | 47 | Inter-Quartile Range 40 to 63 | percentage of FEV-1 predicted |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levalbuterol | 74 | |
| Overall Study | STARTED | Levalbuterol Plus Ipratropium | 67 | |
| Overall Study | COMPLETED | Levalbuterol | 74 | |
| Overall Study | COMPLETED | Levalbuterol Plus Ipratropium | 67 | |
| Overall Study | NOT COMPLETED | Levalbuterol | 0 | |
| Overall Study | NOT COMPLETED | Levalbuterol Plus Ipratropium | 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 | Levalbuterol | 0 | 74 |
| Total, all-cause mortality | Levalbuterol Plus Ipratropium | 0 | 67 |
| Total, other adverse events | Levalbuterol | 0 | 74 |
| Total, other adverse events | Levalbuterol Plus Ipratropium | 0 | 67 |
| Total, serious adverse events | Levalbuterol | 0 | 74 |
| Total, serious adverse events | Levalbuterol Plus Ipratropium | 0 | 67 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Levalbuterol vs Levalbuterol Plus Ipratropium: Number of Participants With Bronchodilation | Trial comparisons |
| Levalbuterol vs Levalbuterol Plus Ipratropium: deaths from any cause | Trial comparisons |
| Levalbuterol vs Levalbuterol Plus Ipratropium: serious adverse events | 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/NCT00583778
GET https://conductscience.org/api/trials/v1/NCT00583778/registered