Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
COPD, Chronic Bronchitis, Chronic Emphysema
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. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Interventions
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Days -21, -14, 0, 14, 28, and 42 |
Secondary
| Measure | Time frame |
|---|---|
| Exacerbations of COPD | Days -14, 0, 14, 28, 42 |
| COPD symptom ratings | Days 0, 14, 28, 42 |
| Baseline dyspnea and transitional dyspnea indices | Days 0, 14, 28, 42 |
| Spirometry parameters | Days -21, -14, 0, 14, 28, and 42 |
| Short acting Beta-agonist MDI use | Days 0, 14, 28, 42 |
| Subject and physician global evaluations | Days 14, 28, 42 |
| St. George's Hospital Respiratory Questionnaire (SGRQ). | Days 0, 42 |
| Ipatropium Bromide MDI use | Day 0, 14, 28, 42 |
Countries
Canada, United States
Outcome results
None listed