N/A
Completed N=141
A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation
Source: ClinicalTrials.gov NCT00583778 ↗Enrolled (actual)
141
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Number of Participants With Bronchodilation — 74; 67 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Bronchodilation |
74; 67 | — |
| PRIMARY Change in FEV-1 % Predicted Over Time |
45; 47 | < 0.05 sig |
Eligibility Criteria
Inclusion Criteria
- 18-45 years of age
- history of asthma
- FEV1 > 50% of predicted for their height, age, gender and race upon presentation to the ED
- no other cause of wheezing or shortness of breath except for asthma as determined by the Investigator
- no history of glaucoma
- no Ipratropium or other anticholinergics within 6 hours of study
Exclusion Criteria
- subjects who, in the investigator's opinion, have life-threatening asthma requiring emergent intervention precluding the ability to complete the treatments during the treatment period
- based upon history or physical exam in the ED orClinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema
- subject with a known sensitivity to levalbuterol or racemic albuterol
- known 20 pack year smoker
- use of ipratropium 6 hours prior to presenting to the ED
- subject who may be pregnant or is pregnant es evidenced by pregnancy test
Data sourced from ClinicalTrials.gov (NCT00583778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.