Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A Double-Blind, Randomized, Multicenter, Parallel-Group Study of Levalbuterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
NCT number | NCT00665600 |
Other study ID # | 051-914 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | February 2002 |
Est. completion date | March 2003 |
Verified date | June 2023 |
Source | Sunovion |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of treatment in COPD.
Status | Completed |
Enrollment | 257 |
Est. completion date | March 2003 |
Est. primary completion date | March 2003 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sunovion |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Spirometry parameters | Days -21, -14, 0, 14, 28, and 42 | ||
Secondary | Exacerbations of COPD | Days -14, 0, 14, 28, 42 | ||
Secondary | COPD symptom ratings | Days 0, 14, 28, 42 | ||
Secondary | Baseline dyspnea and transitional dyspnea indices | Days 0, 14, 28, 42 | ||
Secondary | Ipatropium Bromide MDI use | Day 0, 14, 28, 42 | ||
Secondary | Short acting Beta-agonist MDI use | Days 0, 14, 28, 42 | ||
Secondary | Subject and physician global evaluations | Days 14, 28, 42 | ||
Secondary | St. George's Hospital Respiratory Questionnaire (SGRQ). | Days 0, 42 |
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