Official Title: “A Randomized, Double-Blind Study to Determine the Efficacy of Levalbuterol Versus Racemic Albuterol in the Treatment of Acute Asthma”

To investigate the Efficacy and Safety of Levalbuterol versus Racemic Albuterol in the Treatment of Acute Asthma.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2002

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.

Intervention(s) in this Clinical Trial

• Drug: Levalbuterol 1.25 mg
  • 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
• Drug: Racemic Albuterol Sulfate
  • 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Levalbuterol 1.25 mg
• Active Comparator: 2
  • Racemic Albuterol 2.5 mg

Primary Measures

• Time to meet discharge criteria (functional airway improvement)during the first 3 hours of Period I.
  • Time Frame: 24 hours
    Safety Issue?: Yes

Secondary Measures

• 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
  • Time Frame: Day 0 (5-10 min after every dose)
    Safety Issue?: No
• 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
  • Time Frame: Days 3, 10
    Safety Issue?: No
• Investigator and subject global evaluations, subject preference
  • Time Frame: Days 3, 10
    Safety Issue?: Yes
• Subject reported beta-mediated side effects
  • Time Frame: Days 3, 10
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sepracor, Inc.

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00667407

Study ID Number: 051-915

ClinicalTrials.gov Identifier: NCT00667407

Health Authority: United States: Food and Drug Administration