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

Amgen

Status and phase

Completed

Phase 1

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: MP-376 (Levofloxacin solution for Inhalation)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00752414

Mpex-301

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (selected):

>/= 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

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