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Completed

NCT Number: NCT00739648

A Phase 2 Study of MP-376 to Prevent Acute Exacerbations 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 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 2

Primary location

Haleyville, Alabama, United States

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About this study

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.

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
  • 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

(selected):

  • 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

Treatment and study plan

MP-376

Drug

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

Other names: Levofloxacin inhalation solution, Aeroquin

Placebo

Drug

same frequency as study drug using the same method of delivery

Other names: MP-376 color-matched placebo

Primary outcomes

  1. Exacerbation Rate

    Time frame: From randomization to the patients final study visit (up to 12 months)

    The number of acute exacerbations per patient-year of study participation, where an acute exacerbation was defined as a deterioration in respiratory symptoms that required treatment with antibiotics, corticosteroids, hospitalization or a combination of those treatments.

Secondary outcomes

  1. Duration of Acute Exacerbation

    Time frame: from randomization to the patient's final study visit (up to 12 months)

    From the beginning of antibiotics and/or systemic corticosteroids to the end of antibiotics and/or systemic corticosteroids, whichever was longer, for treatment of the first acute exacerbation

  2. Percent Change in Forced Vital Capacity (FVC)

    Time frame: from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)

    The percent change in the amount of air a patient can inhale

  3. Percent Change in Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)

    The percent change in the amount of air a patient can exhale in 1 second

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of MP-376 Inhalation Solution Administered for 5 Days Every 28 Days to Prevent Acute Exacerbations in High Risk COPD Patients

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 22, 2008
Registry last updated
Dec 27, 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.

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