A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT ID: NCT00739648

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-04-30

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.

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

same frequency as study drug using the same method of delivery

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

Group Type: EXPERIMENTAL

MP-376

Intervention Type: DRUG

MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles

Interventions

MP-376

MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles

Intervention Type: DRUG

Placebo

same frequency as study drug using the same method of delivery

Intervention Type: DRUG

Other Intervention Names

Levofloxacin inhalation solution; Aeroquin; MP-376 color-matched placebo

Eligibility Criteria

Inclusion Criteria

• > 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

• 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Haleyville, Alabama, United States

Hueytown, Alabama, United States

Mobile, Alabama, United States

Montgomery, Alabama, United States

Glendale, Arizona, United States

Phoenix, Arizona, United States

Chula Vista, California, United States

Lomita, California, United States

Long Beach, California, United States

Mission Viejo, California, United States

Oceanside, California, United States

Palo Alto, California, United States

Riverside, California, United States

San Diego, California, United States

San Jose, California, United States

Wheat Ridge, Colorado, United States

Clearwater, Florida, United States

DeBary, Florida, United States

DeLand, Florida, United States

Orlando, Florida, United States

Savannah, Georgia, United States

New Orleans, Louisiana, United States

Taylor, Michigan, United States

Omaha, Nebraska, United States

Buffalo, New York, United States

Ithaca, New York, United States

Greenville, North Carolina, United States

Columbus, Ohio, United States

Maumee, Ohio, United States

Toledo, Ohio, United States

Medford, Oregon, United States

Johnston, Rhode Island, United States

Easley, South Carolina, United States

Gaffney, South Carolina, United States

Spartanburg, South Carolina, United States

Union, South Carolina, United States

San Antonio, Texas, United States

Richmond, Virginia, United States

Salem, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25287629 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24432712 (View on PubMed)

Other Identifiers

Mpex-302

Identifier Type: -

Identifier Source: org_study_id