Phase 4 N=89 Randomized Single-blind Supportive Care

Effect of Nebulized Bronchodilators on Heart Rate

COPD · Sepsis · Shock

Bottom Line

View on ClinicalTrials.gov: NCT01151579 ↗

Enrolled (actual)

Serious AEs

5.6%

Results posted

Oct 2015

Primary outcome: Primary: Heart Rate in Beats Per Minute — -0.16; 1.40 bpm — p=0.01

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Levalbuterol (Drug); Albuterol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Fahim Khorfan, MD
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Heart Rate in Beats Per Minute	-0.16; 1.40	0.01 sig
SECONDARY Arrhythmias	0.33; 1.3	0.05
SECONDARY Total Number of Participants With Arrhythmias	2; 3	—

Summary

The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs.

Eligibility Criteria

Inclusion Criteria

Adults who required inhaled bronchodilator therapy in the form of short acting beta adrenergic receptor agonist and short acting anti-cholinergic treatment every 4-6 hours for respiratory functions

Exclusion Criteria

Known allergy or sensitivity to study medications
Baseline heart rate was greater than 110 beats per minute

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01151579). 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.