A Phase 4 interventional study of Levalbuterol and Albuterol in COPD, Sepsis and Shock, sponsored by Fahim Khorfan, MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-23.
Sponsored by Fahim Khorfan, MD · Phase 4, Interventional, and Supportive care
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.
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.
This is the only study on the registry with Fahim Khorfan, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg.
Drug: Levalbuterol · Drug: Albuterol
Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
Drug: Levalbuterol · Drug: Albuterol
inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg
Also known as: Xopenex, ipratropium
Nebulized albuterol 2.5mg
Also known as: Salbutamol
Heart Rate in Beats Per Minute
Average difference in Heart rate between pre and post breathing treatments
Time frame: Five days
Arrhythmias
Any new arrhythmia documented in the medical record that occurred between breathing treatments.
Time frame: 15 minutes after each treatment for average of 3 to 5 days
Total Number of Participants With Arrhythmias
Documented new arrhythmia occurring during study.
Time frame: Five days
Recruitment began initially August 21, 2007 at the medical center ICU.
| Milestone | Nebulized Albuterol 2.5mg | Levalbuterol 1.25 |
|---|---|---|
| Started | 58 | 31 |
| Completed | 46 | 24 |
| Not completed | 12 | 7 |
| Withdrew: Physician decision | 3 | 1 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Not meet inclusion criteria | 6 | 4 |
Average difference in Heart rate between pre and post breathing treatments
| bpm | Nebulized Albuterol 2.5mg | Levalbuterol 1.25 |
|---|---|---|
| Heart Rate in Beats Per Minute | -0.16 ± 5.1 | 1.40 ± 5.4 |
Any new arrhythmia documented in the medical record that occurred between breathing treatments.
| percent | Nebulized Albuterol 2.5mg | Levalbuterol 1.25 |
|---|---|---|
| Arrhythmias | 0.33 | 1.3 |
Documented new arrhythmia occurring during study.
| participants | Nebulized Albuterol 2.5mg | Levalbuterol 1.25 |
|---|---|---|
| Total Number of Participants With Arrhythmias | 2 | 3 |
Collected over Within 5 days of treatment initiation and within 15 minutes of each individual treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nebulized Albuterol 2.5mg | — | 2/58 (3.4%) | 0/58 (0%) |
| Levalbuterol 1.25 | — | 3/31 (9.7%) | 0/31 (0%) |
| Event | Nebulized Albuterol 2.5mg | Levalbuterol 1.25 |
|---|---|---|
| Ventricular tachycardiaCardiac disorders | 2/58 | 3/31 |
The number analyzed was determined by the power calculation and based on the number of participants randomized to treatment.
| Age, Categorical(Participants) | Nebulized Albuterol 2.5mg | Levalbuterol 1.25 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 9 | 27 |
| >=65 years | 40 | 22 | 62 |
| Age, Continuous(years) | Nebulized Albuterol 2.5mg | Levalbuterol 1.25 | Total |
|---|---|---|---|
| Mean | 67.3 ± 13.1 | 67.5 ± 13.7 | 67.3 ± 13.4 |
| Sex: Female, Male(Participants) | Nebulized Albuterol 2.5mg | Levalbuterol 1.25 | Total |
|---|---|---|---|
| Female | 31 | 12 | 43 |
| Male | 27 | 19 | 46 |
| Region of Enrollment(participants) | Nebulized Albuterol 2.5mg | Levalbuterol 1.25 | Total |
|---|---|---|---|
| United States | 58 | 31 | 89 |
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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