Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma
Information source: Sepracor, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Levalbuterol 1.25 mg (Drug); Racemic Albuterol Sulfate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sepracor, Inc.
Summary
To investigate the Efficacy and Safety of Levalbuterol versus Racemic Albuterol in the
Treatment of Acute Asthma.
Clinical Details
Official title: A Randomized, Double-Blind Study to Determine the Efficacy of Levalbuterol Versus Racemic Albuterol in the Treatment of Acute Asthma
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Time to meet discharge criteria (functional airway improvement)during the first 3 hours of Period I.
Secondary outcome: 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 careFEV1 (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 Investigator and subject global evaluations, subject preference Subject reported beta-mediated side effects
Detailed description:
This study is a double-blind, randomized, active-controlled, multicenter, parallel-group
trial of levalbuterol in adult subjects with acute reversible airways disease. Approximately
600 subjects will be enrolled and study participation will consist of 2 periods: Period I
(Acute Period): Double-blind treatment in the Emergency Department (ED) or Clinic until
disposition, for a maximum of 24 hours of double-blind treatment and Period II (Post-Acute
Period): Subjects discharged from the ED or Clinic will continue double blind treatment (with
the same treatment provided as rescue medication as MDI) for approximately 10 days. Subjects
will be contacted by telephone 30 days post discharge to assess relapse.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Locations and Contacts
Hoover, Alabama, United States
Montgomery, Alabama, United States
Fresno, California, United States
Oakland, California, United States
Torrance, California, United States
Encinitas, California, United States
Colorado Springs, Colorado, United States
Jacksonville, Florida, United States
Gainesville, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Metairie, Louisiana, United States
Detroit, Michigan, United States
Ann Arbor, Michigan, United States
Kansas City, Missouri, United States
St. Louis, Missouri, United States
Red Bank, New Jersey, United States
Syracuse, New York, United States
New Hyde Park, New York, United States
Brooklyn, New York, United States
Rocky Mount, North Carolina, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Lake Oswego, Oregon, United States
Medford, Oregon, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Additional Information
Starting date: November 2000
Ending date: August 2002
Last updated: June 5, 2008
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