Status:
COMPLETED
A Phase 1b Study to Evaluate the Safety and PK of MP-376 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Lead Sponsor:
Amgen
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE1
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 1b, multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of MP-376 solution for inhalation given for 5...
Eligibility Criteria
Inclusion
- Inclusion Criteria (selected):
- \>/= 40 years of age
- History of COPD
- FEV1 \</= 65% of predicted and FEV1/FVC \</= 0.7 value at Screening
- Clinically stable with no changes in health status within the last 30 days
- Lifetime smoking history of at least 15 pack-years
- Willing and able to give informed consent
- 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
- CrCl \< 50/ml/min, AST, ALT or total bilirubin \>/= 3 x ULN at Screening
- Significant or unstable medical conditions
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00752414
Start Date
July 1 2008
End Date
October 1 2008
Last Update
December 4 2024
Active Locations (5)
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1
Mobile, Alabama, United States, 36608
2
Phoenix, Arizona, United States, 85006
3
Omaha, Nebraska, United States, 68154
4
Buffalo, New York, United States, 14215