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

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mobile, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MP-376 (Levofloxacin solution for Inhalation)

Drug

Daily for 5 days

Placebo

Drug

same frequency as MP-376

Primary outcomes

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

Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

Phase 1b, Randomized, Single-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MP-376 Inhalation Solution Administered for 5 Days to Chronic Bronchitis Patients

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Sep 15, 2008
Registry last updated: Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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