A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation - Full Text View

Sponsors and Collaborators:	MetroHealth Medical Center Sepracor, Inc.
Information provided by:	MetroHealth Medical Center
ClinicalTrials.gov Identifier:	NCT00583778

Purpose

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.

Condition	Intervention
Asthma	Drug: ipratropium

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Ipratropium bromide Levalbuterol hydrochloride Albuterol sulfate Ipratropium Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:

To determine if 1.25mg nebulized levalbuterol + 0.5mg nebulized ipratropium administered every 20 minutes for a total of 3 doses provides greater bronchodilation than 1.25mg nebulized levalbuterol administered every 20 minutes for a total of 3 doses. [ Time Frame: Pre-tx & 60 min. post 3rd tx FEV1 ] [ Designated as safety issue: No ]

Estimated Enrollment:	152
Study Start Date:	August 2004
Estimated Study Completion Date:	February 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator levalbuterol 1.25 mg every 20 minutes for 3 doses plus placebo (saline)	Drug: ipratropium 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses
2: Experimental ipratropium 0.5 mg nebulized every 20 minutes for 3 doses added to levalbuterol 1.25 mg every 20 minutes for 3 doses	Drug: ipratropium 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses

Detailed Description:

Patients will then receive, in a randomized double-blinded fashion, levalbuterol, 1.25mg every 20 minutes for a total of 3 aerosolized doses combined with ipratropium, 0.5mg every 20 minutes for a total of 3 aerosolized doses. The medication will be premixed by the pharmacy in a total of 3 ml of normal saline and the nebulizer will be driven with oxygen at 6 liters per minute. A second plasma sample for analysis of albuterol isomers will be drawn within a fifteen minute window following the third aerosol treatment. Spirometry will be repeated again at 30 and 60 minutes after the third aerosol treatment (Figure 1). All patients will receive prednisone, 60mg orally immediately after their first dose of aerosolized medications, unless contraindications to prednisone administration are present. Patients will not receive any other medications during the time course of the study. Vital signs and pulse oximetry will be repeated prior to each nebulized treatment and again 30 minutes after the third nebulized treatment.

The study will terminate 60 minutes after the third aerosol administration. At that point, any further therapy will be at the discretion of the treating physician. Patients will be questioned about the occurrence of any side effects from levalbuterol treatment including palpitations, anxiety, nausea, vomiting or headache. Patients will also be questioned about the occurrence of any side effects from ipratropium, including dry mouth, dry eyes, and urinary retention. Patients will be withdrawn from the study at any point these side effects become intolerable to the patient or any time the patient so desires. Patients will also be withdrawn if they develop palpitations and have an ECG that demonstrates ventricular or supraventricular tachycardia.

Patients will be called 14 days after their ED visit to assess relapse or recurrence of acute asthma exacerbation. In addition, a chart review will be performed to assess relapse or recurrence of acute asthma exacerbation, as well as determine hospital length of stay in those patients who required admission after the initial visit.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583778

Contacts

Contact: Rita K Cydulka, MD

216.778.3435 ext 83435

rcydulka@metrohealth.org

Locations

United States, Ohio
MetroHealth Medical Center	Recruiting
Cleveland, Ohio, United States, 44109
Principal Investigator: Rita K Cydulka, MD

Sponsors and Collaborators

MetroHealth Medical Center

Sepracor, Inc.

Investigators

Principal Investigator:

Rita K Cydulkla, MD

MetroHealth Medical Center

More Information

No publications provided

Responsible Party:	MetroHealth Medical Center ( Rita Cydulka )
Study ID Numbers:	IRB04-00127
Study First Received:	December 20, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00583778 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by MetroHealth Medical Center:

Asthma
Bronchodilators
Levalbuterol
Ipratropium

Study placed in the following topic categories:

Neurotransmitter Agents
Cholinergic Antagonists
Adrenergic beta-Agonists
Adrenergic Agents
Bronchial Diseases
Albuterol
Asthma
Anti-Asthmatic Agents
Cholinergic Agents
Adrenergic Agonists

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Ipratropium
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Adrenergic Agents
Albuterol
Physiological Effects of Drugs
Reproductive Control Agents
Cholinergic Agents
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases

Tocolytic Agents
Therapeutic Uses
Immune System Diseases
Adrenergic beta-Agonists
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions
Ipratropium
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on July 02, 2009