Effect of Nebulized Bronchodilators on Heart Rate

Fahim Khorfan, MD

Status and phase: Completed; Phase 4

Conditions: Shock; COPD; Sepsis

Treatments: Drug: Albuterol; Drug: Levalbuterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01151579

ME 07-0011

Details and patient eligibility

About

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.

Full description

A randomized, single-blind, cross-over, prospective study was conducted in seventy critically ill adult patients with acute air flow obstruction. Patients were randomized to nebulized albuterol alternating with levalbuterol every 4 to 6 hours. Group A received albuterol 2.5 mg alternating with levalbuterol 0.63 mg. Group B received albuterol 2.5 mg alternating with levalbuterol 1.25 mg. All patients received nebulized ipratropium bromide 500 micrograms with each treatment. Heart rate and cardiac rhythm were continuously recorded before and 15 minutes after finishing each treatment. Any new rhythm abnormalities between treatments were also recorded.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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89 participants in 2 patient groups

Levalbuterol 0.63

Active Comparator group

Description:

Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg.

Treatment:

Drug: Albuterol

Drug: Levalbuterol

Levalbuterol 1.25

Active Comparator group

Description:

Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.

Treatment:

Drug: Albuterol

Drug: Levalbuterol