Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD) - Tabular View

Tracking Information
First Received Date ^ICMJE	April 22, 2008
Last Updated Date	April 23, 2008
Start Date ^ICMJE	February 2002
Primary Completion Date	March 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 23, 2008)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00665600 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 23, 2008)	Spirometry parameters [ Time Frame: Days -21, -14, 0, 14, 28, and 42 ] [ Designated as safety issue: No ] Exacerbations of COPD [ Time Frame: Days -14, 0, 14, 28, 42 ] [ Designated as safety issue: Yes ] COPD symptom ratings [ Time Frame: Days 0, 14, 28, 42 ] [ Designated as safety issue: Yes ] Baseline dyspnea and transitional dyspnea indices [ Time Frame: Days 0, 14, 28, 42 ] [ Designated as safety issue: Yes ] Ipatropium Bromide MDI use [ Time Frame: Day 0, 14, 28, 42 ] [ Designated as safety issue: Yes ] Short acting Beta-agonist MDI use [ Time Frame: Days 0, 14, 28, 42 ] [ Designated as safety issue: Yes ] Subject and physician global evaluations [ Time Frame: Days 14, 28, 42 ] [ Designated as safety issue: Yes ] St. George's Hospital Respiratory Questionnaire (SGRQ). [ Time Frame: Days 0, 42 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD)
Official Title ^ICMJE	A Double-Blind, Randomized, Multicenter, Parallel-Group Study of Levalbuterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
Brief Summary	To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of treatment in COPD.
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Chronic Obstructive Pulmonary Disease (COPD)
Intervention ^ICMJE	Drug: Levalbuterol HCl Drug: Albuterol Sulfate Drug: Placebo
Study Arms / Comparison Groups	Experimental: Levalbuterol 0.63 mg TID Experimental: Levalbuterol 1.25 mg TID Active Comparator: Racemic Albuterol 2.5 mg TID Placebo Comparator: Placebo TID
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	257
Completion Date	March 2003
Primary Completion Date	March 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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	Both
Ages	35 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00665600
Responsible Party	Xopenex Medical Affairs Director, Sepracor
Study ID Numbers ^ICMJE	051-914
Study Sponsor ^ICMJE	Sepracor, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Sepracor, Inc.
Verification Date	April 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP