A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of MP-376 Inhalation Solution Administered for 5 Days Every 28 Days to Prevent Acute Exacerbations in High Risk COPD Patients
1 other identifier
interventional
322
1 country
39
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 morbidity, specifically an increased risk of death, a decline in pulmonary function and a significant change in quality of life. Bacteria appear to have an important role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In addition, recent studies indicate that acquisition of a new strain of H. influenzae, M. catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations. Chronic inflammation and bacterial infection predispose many patients to frequent and recurrent acute exacerbations. Mpex believes that intermittent administration of inhaled MP-376 in high risk patients will decrease the incidence of acute exacerbations by both by lowering the organism burden, and resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial strains.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 chronic-obstructive-pulmonary-disease
Started Oct 2008
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2008
CompletedFirst Posted
Study publicly available on registry
August 22, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
March 2, 2012
CompletedDecember 27, 2024
December 1, 2024
1.3 years
August 20, 2008
September 4, 2011
December 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exacerbation Rate
The number of acute exacerbations per patient-year of study participation, where an acute exacerbation was defined as a deterioration in respiratory symptoms that required treatment with antibiotics, corticosteroids, hospitalization or a combination of those treatments.
From randomization to the patients final study visit (up to 12 months)
Secondary Outcomes (3)
Duration of Acute Exacerbation
from randomization to the patient's final study visit (up to 12 months)
Percent Change in Forced Vital Capacity (FVC)
from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)
Percent Change in Forced Expiratory Volume in 1 Second (FEV1)
from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
MP-376 240 mg Twice Daily (BID)
EXPERIMENTALMP-376 240 mg BID inhaled via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
Interventions
MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles
same frequency as study drug using the same method of delivery
Eligibility Criteria
You may qualify if:
- \> 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (39)
Unknown Facility
Haleyville, Alabama, 35565, United States
Unknown Facility
Hueytown, Alabama, 35023, United States
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Montgomery, Alabama, 36117, United States
Unknown Facility
Glendale, Arizona, 85306, United States
Unknown Facility
Phoenix, Arizona, 85006, United States
Unknown Facility
Chula Vista, California, 91911, United States
Unknown Facility
Lomita, California, 90717, United States
Unknown Facility
Long Beach, California, 90822, United States
Unknown Facility
Mission Viejo, California, 92691, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
Palo Alto, California, 94304, United States
Unknown Facility
Riverside, California, 92506, United States
Unknown Facility
San Diego, California, 92117, United States
Unknown Facility
San Jose, California, 95124, United States
Unknown Facility
Wheat Ridge, Colorado, 80033, United States
Unknown Facility
Clearwater, Florida, 33765, United States
Unknown Facility
DeBary, Florida, 32713, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Orlando, Florida, 32806, United States
Unknown Facility
Savannah, Georgia, 31406, United States
Unknown Facility
New Orleans, Louisiana, 70115, United States
Unknown Facility
Taylor, Michigan, 48180, United States
Unknown Facility
Omaha, Nebraska, 68198, United States
Unknown Facility
Buffalo, New York, 14215, United States
Unknown Facility
Ithaca, New York, 14850, United States
Unknown Facility
Greenville, North Carolina, 27834, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Maumee, Ohio, 43537, United States
Unknown Facility
Toledo, Ohio, 43614, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Johnston, Rhode Island, 02919, United States
Unknown Facility
Easley, South Carolina, 29640, United States
Unknown Facility
Gaffney, South Carolina, 29340, United States
Unknown Facility
Spartanburg, South Carolina, 29303, United States
Unknown Facility
Union, South Carolina, 29379, United States
Unknown Facility
San Antonio, Texas, 78212, United States
Unknown Facility
Richmond, Virginia, 23225, United States
Unknown Facility
Salem, Virginia, 24153, United States
Related Publications (2)
Leidy NK, Murray LT, Monz BU, Nelsen L, Goldman M, Jones PW, Dansie EJ, Sethi S. Measuring respiratory symptoms of COPD: performance of the EXACT- Respiratory Symptoms Tool (E-RS) in three clinical trials. Respir Res. 2014 Oct 7;15(1):124. doi: 10.1186/s12931-014-0124-z.
PMID: 25287629DERIVEDLeidy NK, Murray LT, Jones P, Sethi S. Performance of the EXAcerbations of chronic pulmonary disease tool patient-reported outcome measure in three clinical trials of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Mar;11(3):316-25. doi: 10.1513/AnnalsATS.201309-305OC.
PMID: 24432712DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffery Nieves, PharmD, Senior Director
- Organization
- Horizon Pharma USA, Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2008
First Posted
August 22, 2008
Study Start
October 1, 2008
Primary Completion
January 1, 2010
Study Completion
April 1, 2010
Last Updated
December 27, 2024
Results First Posted
March 2, 2012
Record last verified: 2024-12