Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD)
Information source: Sepracor, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)
Intervention: Levalbuterol HCl (Drug); Levalbuterol HCl (Drug); Albuterol Sulfate (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sepracor, Inc.
Summary
To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of
treatment in COPD.
Clinical Details
Official title: A Double-Blind, Randomized, Multicenter, Parallel-Group Study of Levalbuterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: Spirometry parametersExacerbations of COPD COPD symptom ratings Baseline dyspnea and transitional dyspnea indices Ipatropium Bromide MDI use Short acting Beta-agonist MDI use Subject and physician global evaluations St. George's Hospital Respiratory Questionnaire (SGRQ).
Detailed description:
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.
Eligibility
Minimum age: 35 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Calgary, Alberta, Canada
Spring Valley, California, United States
Carmichael, California, United States
Wheat Ridge, Colorado, United States
Largo, Florida, United States
Miami, Florida, United States
Panama City, Florida, United States
Atlanta, Georgia, United States
Elk Grove Village, Illinois, United States
Hines, Illinois, United States
Winnepeg, Manitoba, Canada
Wheaton, Maryland, United States
Springfield, Massachusetts, United States
Cadillac, Michigan, United States
Columbia, Missouri, United States
Missoula, Montana, United States
Springfield, New Jersey, United States
Chapel Hill, North Carolina, United States
Mogadore, Ohio, United States
Mississauga, Ontario, Canada
Toronto, Ontario, Canada
Providence, Rhode Island, United States
San Antonio, Texas, United States
Austin, Texas, United States
Additional Information
Starting date: February 2002
Ending date: March 2003
Last updated: April 23, 2008
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