Official Title: “A Double-Blind, Randomized, Multicenter, Parallel-Group Study of Levalbuterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease”

To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of treatment in COPD.

Study Type: Interventional

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

Study Primary Completion Date: March 2003

This study is a multi-center, randomized, double-blind, placebo and active controlled, parallel-group study of adult subjects with COPD. Approximately 250 subjects will be enrolled to randomize at least 200 subjects. Study participation will consist of a total of six study visits over nine weeks for each subject.

Intervention(s) in this Clinical Trial

• Drug: Levalbuterol HCl
  • Levalbuterol 0.63 TID
• Drug: Levalbuterol HCl
  • Levabuterol 1.25 mg TID
• Drug: Albuterol Sulfate
  • Racemic albuterol 2.5 mg TID
• Drug: Placebo
  • Placebo TID

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Levalbuterol 0.63 mg TID
• Experimental: 2
  • Levalbuterol 1.25 mg TID
• Active Comparator: 3
  • Racemic Albuterol 2.5 mg TID
• Placebo Comparator: 4
  • Placebo TID

Primary Measures

• The primary efficacy endpoint was the time-normalized area under the percent change from visit predose in FEV1 curve (nAUC0-8 hours) averaged over the six week double-blind period.
  • Time Frame: Days -21, -14, 0, 14, 28, and 42
    Safety Issue?: No

Secondary Measures

• Spirometry parameters
  • Time Frame: Days -21, -14, 0, 14, 28, and 42
    Safety Issue?: No
• Exacerbations of COPD
  • Time Frame: Days -14, 0, 14, 28, 42
    Safety Issue?: Yes
• COPD symptom ratings
  • Time Frame: Days 0, 14, 28, 42
    Safety Issue?: Yes
• Baseline dyspnea and transitional dyspnea indices
  • Time Frame: Days 0, 14, 28, 42
    Safety Issue?: Yes
• Ipatropium Bromide MDI use
  • Time Frame: Day 0, 14, 28, 42
    Safety Issue?: Yes
• Short acting Beta-agonist MDI use
  • Time Frame: Days 0, 14, 28, 42
    Safety Issue?: Yes
• Subject and physician global evaluations
  • Time Frame: Days 14, 28, 42
    Safety Issue?: Yes
• St. George's Hospital Respiratory Questionnaire (SGRQ).
  • Time Frame: Days 0, 42
    Safety Issue?: Yes

Inclusion Criteria:

• Male and female subjects must be at least greater than or equal to 35 years of age at the time of consent.
• Subjects must have a pre-established primary clinical diagnosis of COPD.
• Subjects must have a baseline FEV1 less than or equal to 65%
• Subjects must have a predicted and >0.70 Liter
• subject was taking steroids (inhaled, oral, or nasal), short-acting xanthines, or leukotrienes, the dose must have been stable for 30 days
• Subjects must have a FEV1/forced vital capacity (FVC) less than or equal to 70%
• Subjects must have a greater than or equal to 15 pack-year smoking history
• Subjects must have a baseline medical research council (MRC) dyspnea scale score greater than or equal to 2
• Regular use of a prescribed therapy for control of COPD symptoms for 3 months prior to study entry.
• No COPD exacerbations that have required an emergency room visit, hospital admission or intensive out-patient therapy within 1 month prior to study entry

Exclusion Criteria:

• Females who are pregnant or lactating.
• Concurrent requirement of oxygen therapy
• Known history of asthma, or any chronic respiratory disease other than COPD (not including chronic bronchitis or emphysema).
• Diagnosis of cancer within 5 years prior to study entry with the exception of non-melanoma skin cancer.
• Lung resection of more than one full lobe.
• Use of intravenous, intra-articular or intramuscular corticosteroids within 30 days of study entry
• History of upper or lower respiratory infection within 14 days of study entry.
• Participation in an investigational drug study within 30 days of study entry.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 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 August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00665600

Study ID Number: 051-914

ClinicalTrials.gov Identifier: NCT00665600

Health Authority: United States: Food and Drug Administration