N/A N=141 Randomized Triple-blind Treatment

A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00583778 ↗

Enrolled (actual)

141

Serious AEs

0.0%

Results posted

May 2022

Primary outcome: Primary: Number of Participants With Bronchodilation — 74; 67 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ipratropium (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: MetroHealth Medical Center
Primary completion: Nov 2008

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

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.

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

View full record on ClinicalTrials.gov →

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.