A Phase 1b Study to Evaluate the Safety and PK of MP-376 in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT00752414 | Completed Phase 1

• 1 other identifier: Mpex-301
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 5

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, (the sponsor on record at time of the study's initial registration) 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Patients

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety, tolerability and PK of two dosage regimens of MP-376

  2 weeks

Study Arms (2)

1

EXPERIMENTAL

MP-376 Inhalation Solution

Drug: MP-376 (Levofloxacin solution for Inhalation)

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

MP-376 (Levofloxacin solution for Inhalation) DRUG

Daily for 5 days

1

Placebo DRUG

same frequency as MP-376

2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>/= 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

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
• CrCl \< 50/ml/min, AST, ALT or total bilirubin \>/= 3 x ULN at Screening
• Significant or unstable medical conditions

Sponsors & Collaborators

• Amgen: lead

Study Sites (5)

Unknown Facility

Mobile, Alabama, 36608, United States

Location

Unknown Facility

Phoenix, Arizona, 85006, United States

Location

Unknown Facility

Omaha, Nebraska, 68154, United States

Location

Unknown Facility

Buffalo, New York, 14215, United States

Location

Unknown Facility

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 15, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

US (5)