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A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mpex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00739648
First received: August 20, 2008
Last updated: January 31, 2012
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: MP-376
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mpex Pharmaceuticals:

Primary Outcome Measures:
  • Exacerbation Rate [ Time Frame: From randomization to the patients final study visit (up to 12 months) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Duration of Acute Exacerbation [ Time Frame: from randomization to the patient's final study visit (up to 12 months) ] [ Designated as safety issue: No ]
    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

  • Percent Change in Forced Vital Capacity (FVC) [ Time Frame: from baseline to the conclusion of the fourth 28-day treatment cycle (4 months) ] [ Designated as safety issue: Yes ]
    The percent change in the amount of air a patient can inhale

  • 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) ] [ Designated as safety issue: Yes ]
    The percent change in the amount of air a patient can exhale in 1 second


Enrollment: 322
Study Start Date: October 2008
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
 Drug: Placebo
same frequency as study drug using the same method of delivery
Other Name: MP-376 color-matched placebo
Experimental: MP-376 240 mg Twice Daily (BID)
MP-376 240 mg BID inhaled via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
 Drug: MP-376
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739648

  Show 40 Study Locations
Sponsors and Collaborators
Mpex Pharmaceuticals
Investigators
Principal Investigator: Sanjay Sethi, M.D. University at Buffalo
  More Information

No publications provided

Responsible Party: Mpex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00739648     History of Changes
Other Study ID Numbers: Mpex-302
Study First Received: August 20, 2008
Results First Received: September 4, 2011
Last Updated: January 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mpex Pharmaceuticals:
COPD
Patients

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on May 16, 2013