Status:
COMPLETED
A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients
Lead Sponsor:
Amgen
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morb...
Detailed Description
This study will be a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of MP-376 inhalation solution given daily for 5 days i...
Eligibility Criteria
Inclusion
- Inclusion Criteria (selected):
- \> 40 years of age
- History of COPD
- Forced expiratory volume in 1 second (FEV1) \</= 70% of predicted and FEV1/Forced vital capacity (FVC) \</= 0.7 value at screening
- Have at least two acute exacerbation episodes in the proceeding year
- Clinically stable with no changes in health status within the last 30 days
- Lifetime smoking history of at least 10 pack-years
- Willing and able to use a daily electronic diary
- Exclusion Criteria (selected):
- Use of any systemic or inhaled antibiotics within 30 days prior to baseline
- History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
- Creatinine clearance \< 40 mg/ml/min, AST, ALT \>/= 5 x upper limit of normal (ULN) or total bilirubin \>/= 3 x ULN at Screening
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT00739648
Start Date
October 1 2008
End Date
April 1 2010
Last Update
December 27 2024
Active Locations (39)
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1
Haleyville, Alabama, United States, 35565
2
Hueytown, Alabama, United States, 35023
3
Mobile, Alabama, United States, 36608
4
Montgomery, Alabama, United States, 36117