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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Placebo; Drug: MP-376

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 in a 28 day treatment cycle to COPD patients.

Study with completed results acquired from Horizon in 2024.

• Study Type: Interventional
• Enrollment (Actual): 322
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Haleyville, Alabama, United States, 35565
    • Hueytown, Alabama, United States, 35023
    • Mobile, Alabama, United States, 36608
    • Montgomery, Alabama, United States, 36117
  • Arizona
    • Glendale, Arizona, United States, 85306
    • Phoenix, Arizona, United States, 85006
  • California
    • Chula Vista, California, United States, 91911
    • Lomita, California, United States, 90717
    • Long Beach, California, United States, 90822
    • Mission Viejo, California, United States, 92691
    • Oceanside, California, United States, 92056
    • Palo Alto, California, United States, 94304
    • Riverside, California, United States, 92506
    • San Diego, California, United States, 92117
    • San Jose, California, United States, 95124
  • Colorado
    • Wheat Ridge, Colorado, United States, 80033
  • Florida
    • Clearwater, Florida, United States, 33765
    • DeBary, Florida, United States, 32713
    • DeLand, Florida, United States, 32720
    • Orlando, Florida, United States, 32806
  • Georgia
    • Savannah, Georgia, United States, 31406
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
  • Michigan
    • Taylor, Michigan, United States, 48180
  • Nebraska
    • Omaha, Nebraska, United States, 68198
  • New York
    • Buffalo, New York, United States, 14215
    • Ithaca, New York, United States, 14850
  • North Carolina
    • Greenville, North Carolina, United States, 27834
  • Ohio
    • Columbus, Ohio, United States, 43210
    • Maumee, Ohio, United States, 43537
    • Toledo, Ohio, United States, 43614
  • Oregon
    • Medford, Oregon, United States, 97504
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
  • South Carolina
    • Easley, South Carolina, United States, 29640
    • Gaffney, South Carolina, United States, 29340
    • Spartanburg, South Carolina, United States, 29303
    • Union, South Carolina, United States, 29379
  • Texas
    • San Antonio, Texas, United States, 78212
  • Virginia
    • Richmond, Virginia, United States, 23225
    • Salem, Virginia, United States, 24153

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Placebo; same frequency as study drug using the same method of delivery; Other Names: 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	Drug: MP-376; MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles; Other Names: Aeroquin; Levofloxacin inhalation solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Acute Exacerbation	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	from randomization to the patient's final study visit (up to 12 months)
Percent Change in Forced Vital Capacity (FVC)	The percent change in the amount of air a patient can inhale	from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)
Percent Change in Forced Expiratory Volume in 1 Second (FEV1)	The percent change in the amount of air a patient can exhale in 1 second	from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

General Publications

• 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.
• Leidy 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: August 20, 2008
• First Submitted That Met QC Criteria: August 21, 2008
• First Posted (Estimated): August 22, 2008

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: COPD; Patients
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anti-Bacterial Agents; Anti-Infective Agents; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Topoisomerase Inhibitors; Topoisomerase II Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Levofloxacin
• Other Study ID Numbers: Mpex-302