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NCT00583778 · ClinicalTrials.gov registry record · NA
A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation
A NA study, sponsored by MetroHealth Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 141
- Enrollment target
NCT00583778: Completed NA study, sponsored by MetroHealth Medical Center.
NCT00583778 is a NA study that has completed, run by MetroHealth Medical Center. The registered enrollment target is 141 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00583778, a NA study, has completed, sponsored by MetroHealth Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 141 participants
- Enrollment target
Study Summary
This is a double blind, controlled clinical trail testing whether three doses of 1.25 mg of nebulized levalbuterol in combination with three doses of 0.5mg of nebulized ipratropium will lead to greater bronchodilation than that achieved by three doses of nebulized 1.25 mg of levalbuterol alone every 20 minutes. The primary hypothesis of this study is that three doses of 1.25 mg of nebulized levalbuterol in combination with three doses of 0.5mg of nebulized ipratropium will lead to greater bronchodilation than that achieved by three doses of nebulized 1.25 mg of levalbuterol alone every 20 minutes. The secondary hypothesis is that the treatment combination of levalbuterol and ipratropium will lead to fewer hospitalizations than levalbuterol alone in patients with acute asthma exacerbation. Other secondary objectives include (1) evaluating the relationship between baseline (S)- albuterol levels and (R)- albuterol levels on presentation and FEV1, (2) the relationship between baseline (S)- albuterol levels and (R)- albuterol levels on presentation and change in FEV1,(3) time to event analysis for an improvement of 15%, 20%, 30%, 40%, and 50% in FEV1 from initial presentation value, (4) analysis of FEV1 at discharge.
Primary Outcome
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 gr
Interventions
- DRUG ipratropium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2004-08 |
| Est. Completion | 2008-12 |
| Phase | NA |
What the finished NCT00583778 record still lists
NCT00583778 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which ipratropium is the first listed.
NCT00583778 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00583778 about?
NCT00583778 is a clinical study titled "A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation". This is a double blind, controlled clinical trail testing whether three doses of 1.25 mg of nebulized levalbuterol in combination with three doses of 0.5mg of nebulized ipratropium will lead to greater bronchodilation than that achieved by three doses of nebulized 1.25 mg of levalbuterol alone every...
What is the current status of trial NCT00583778?
This trial is currently completed. It is a NA study. The enrollment target is 141 participants. The study started on 2004-08. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00583778?
The interventions under investigation include: ipratropium (DRUG).
Who is sponsoring clinical trial NCT00583778?
This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00583778's enrollment target sits among peer trials
141 712th of 2000 higher than 1,288 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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