Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma
A Randomized, Double-Blind Study to Determine the Efficacy of Levalbuterol Versus Racemic Albuterol in the Treatment of Acute Asthma
1 other identifier
interventional
627
1 country
28
Brief Summary
To investigate the Efficacy and Safety of Levalbuterol versus Racemic Albuterol in the Treatment of Acute Asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Nov 2000
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 24, 2008
CompletedFirst Posted
Study publicly available on registry
April 28, 2008
CompletedFebruary 22, 2012
February 1, 2012
1.7 years
April 24, 2008
February 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to meet discharge criteria (functional airway improvement)during the first 3 hours of Period I.
24 hours
Secondary Outcomes (4)
FEV1 (Period I): Serial spirometry, maximum FEV1, time to maximum FEV1, baseline FEV1 severity on subject response; % responders, no. nebulizations to meet discharge criteria, rate of hospitalization, time to admit decision, rate for increased care
Day 0 (5-10 min after every dose)
FEV1 (Period II): Spirometry, average FEV1; distribution of subject responses; rate of relapse; blinded study medication; length of stay in ED or Clinic during Period I; length of hospitalization, cost of care
Days 3, 10
Investigator and subject global evaluations, subject preference
Days 3, 10
Subject reported beta-mediated side effects
Days 3, 10
Study Arms (2)
1
EXPERIMENTALLevalbuterol 1.25 mg
2
ACTIVE COMPARATORRacemic Albuterol 2.5 mg
Interventions
levalbuterol 1.25 mg Period I: administered every 20 minutes for the first 3 doses, and then every 40 minutes for the next 3 doses; then as clinically indicated. Period II: TID for 3 days (same time of day), then PRN to TID for 7 days
Racemic Albuterol 2.5 mg Period I: every 20 min for the first 3 doses, then every 40 min for the next 3 doses, then as clinically indicated. Period II: TID for 3 days then PRN to TID for 7 days
Eligibility Criteria
You may qualify if:
- Male and female subjects must be at least greater than or equal to 18 years of age at the time of consent.
- Subjects must have history of asthma for at least 6 months.
- Subjects must present to the emergency department (ED) or clinic with forced expiratory volume in one second (FEV1) of 20 to 55% (inclusive) predicted at baseline
- Subjects must have O2 saturation greater than or equal to 90% at room air or with no more than 6 Liters/minute supplemental oxygen and no other cause of wheezing or shortness of breath other than asthma as determined by the physician.
- Prior use of a beta-agonist (e.g., Primatine Mist, albuterol, salmeterol, etc.) within 24 hours of presentation to the ED or Clinic.
- Smoked ≤ 10 pack-years or non-smoker.
- Be in good health with the exception of asthma and not suffering from any chronic condition which might affect their lung function, such as COPD or emphysema.
- Near-normal activity level between exacerbations.
- Subjects who are taking inhaled or systemic corticosteroids must be on a stable dose for at least 21 days prior to study entry.
You may not qualify if:
- Subjects who have received treatment for asthma in an ED, Clinic, or Urgent Care Center within 2 weeks prior to study entry.
- Based upon history or physical exam in the ED or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema.
- Subjects with a history of asthma episodes associated with hypercapnia, respiratory arrest, hypoxic seizures, or requiring intubation within 12 months prior to entry.
- Hospitalization for asthma within two months prior to entry.
- Female subjects who are pregnant or lactating.
- Subjects who have a history of a clinically significant psychiatric disorder within the last 3 months, with the exception of mild depression.
- Subjects who have participated in an investigational drug study within 30 days of study entry or have previously participated in the current trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
Hoover, Alabama, United States
Unknown Facility
Montgomery, Alabama, United States
Unknown Facility
Encinitas, California, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
Oakland, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Metairie, Louisiana, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Red Bank, New Jersey, United States
Unknown Facility
Brooklyn, New York, United States
Unknown Facility
New Hyde Park, New York, United States
Unknown Facility
Syracuse, New York, United States
Unknown Facility
Rocky Mount, North Carolina, United States
Unknown Facility
Akron, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Lake Oswego, Oregon, United States
Unknown Facility
Medford, Oregon, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2008
First Posted
April 28, 2008
Study Start
November 1, 2000
Primary Completion
August 1, 2002
Study Completion
August 1, 2002
Last Updated
February 22, 2012
Record last verified: 2012-02