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

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: MP-376 (Levofloxacin solution for Inhalation); Drug: Placebo

• Registration Number: NCT00752414
• Lead Sponsor: Amgen

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.

Detailed Description

This study will be a Phase 1b, multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of MP-376 solution for inhalation given for 5 days to COPD patients.

Study acquired from Horizon in 2024.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-12
• Study First Posted: 2008-09-15
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MP-376 (Levofloxacin solution for Inhalation)	MP-376 Inhalation Solution
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Evaluate the safety, tolerability and PK of two dosage regimens of MP-376	2 weeks