A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients
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.
Chronic Obstructive Pulmonary Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Exacerbation Rate [ Time Frame: From randomization to the patients final study visit (up to 12 months) ] [ Designated as safety issue: No ]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.
- Duration of Acute Exacerbation [ Time Frame: from randomization to the patient's final study visit (up to 12 months) ] [ Designated as safety issue: No ]From the beginning of antibiotics and/or systemic corticosteroids to the end of antibiotics and/or systemic corticosteroids, whichever was longer, for treatment of the first acute exacerbation
- Percent Change in Forced Vital Capacity (FVC) [ Time Frame: from baseline to the conclusion of the fourth 28-day treatment cycle (4 months) ] [ Designated as safety issue: Yes ]The percent change in the amount of air a patient can inhale
- Percent Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: from baseline to the conclusion of the fourth 28-day treatment cycle (4 months) ] [ Designated as safety issue: Yes ]The percent change in the amount of air a patient can exhale in 1 second
|Study Start Date:||October 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
same frequency as study drug using the same method of delivery
Other Name: MP-376 color-matched placebo
Experimental: MP-376 240 mg Twice Daily (BID)
MP-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
MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles
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 in a 28 day treatment cycle to COPD patients.
Show 40 Study Locations
|Principal Investigator:||Sanjay Sethi, M.D.||University at Buffalo|