NCT01151579

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2010

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

October 23, 2015

Completed
Last Updated

October 23, 2015

Status Verified

September 1, 2015

Enrollment Period

11 months

First QC Date

June 24, 2010

Results QC Date

March 12, 2015

Last Update Submit

September 23, 2015

Conditions

COPDSepsisShock

Keywords

Tachycardiatachyarrhythmiasbronchodilator therapyCritically ill patients

Outcome Measures

Primary Outcomes (1)

  • Heart Rate in Beats Per Minute

    Average difference in Heart rate between pre and post breathing treatments

    Five days

Secondary Outcomes (2)

  • Arrhythmias

    15 minutes after each treatment for average of 3 to 5 days

  • Total Number of Participants With Arrhythmias

    Five days

Study Arms (2)

Levalbuterol 0.63

ACTIVE COMPARATOR

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

Drug: LevalbuterolDrug: Albuterol

Levalbuterol 1.25

ACTIVE COMPARATOR

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

Drug: LevalbuterolDrug: Albuterol

Interventions

LevalbuterolDRUG

inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg

Also known as: Xopenex, ipratropium
Levalbuterol 0.63Levalbuterol 1.25
AlbuterolDRUG

Nebulized albuterol 2.5mg

Also known as: Salbutamol
Levalbuterol 0.63Levalbuterol 1.25

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Related Publications (1)

  • Khorfan FM, Smith P, Watt S, Barber KR. Effects of nebulized bronchodilator therapy on heart rate and arrhythmias in critically ill adult patients. Chest. 2011 Dec;140(6):1466-1472. doi: 10.1378/chest.11-0525. Epub 2011 Sep 29.

    PMID: 21960699DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSepsisShockTachycardia

Interventions

LevalbuterolIpratropiumAlbuterol

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammationArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesAtropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Limitations and Caveats

Potential limitations are its single-center site and that the design may not have adequately eliminated all carryover effects from the levalbuterol. However, the number of side effects without carryover would be even lower than we observed.

Results Point of Contact

Title
Dr. Fahim Khorfan
Organization
Genesys Regional Medical Center
kbarber@genesys.org
810-606-7722

Study Officials

  • Fahim Khorfan, MD

    Ascension Health

    PRINCIPAL INVESTIGATOR

  • Kimberly R Barber, PhD

    Ascension Health

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ICU Pulmonologist

Study Record Dates

First Submitted

June 24, 2010

First Posted

June 28, 2010

Study Start

December 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

October 23, 2015

Results First Posted

October 23, 2015

Record last verified: 2015-09

Locations

US(1)