Status:
COMPLETED
Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
35-99 years
Phase:
PHASE3
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 lea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT00665600
Start Date
February 1 2002
End Date
March 1 2003
Last Update
June 27 2023
Active Locations (24)
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1
Carmichael, California, United States
2
Spring Valley, California, United States
3
Wheat Ridge, Colorado, United States
4
Largo, Florida, United States