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

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ClinicalTrials.gov Identifier: NCT00739648
Recruitment Status : Completed
First Posted : August 22, 2008
Results First Posted : March 2, 2012
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma USA, Inc.

Study Description
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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 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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: MP-376 Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739648


Locations
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United States, Alabama
Haleyville, Alabama, United States, 35565
Hueytown, Alabama, United States, 35023
Mobile, Alabama, United States, 36608
Montgomery, Alabama, United States, 36117
United States, Arizona
Glendale, Arizona, United States, 85306
Phoenix, Arizona, United States, 85006
United States, California
Chula Vista, California, United States, 91911
Lomita, California, United States, 90717
Long Beach, California, United States, 90822
Mission Viejo, California, United States, 92691
Oceanside, California, United States, 92056
Palo Alto, California, United States, 94304
Riverside, California, United States, 92506
San Diego, California, United States, 92117
San Jose, California, United States, 95124
United States, Colorado
Wheat Ridge, Colorado, United States, 80033
United States, Florida
Clearwater, Florida, United States, 33765
DeBary, Florida, United States, 32713
DeLand, Florida, United States, 32720
Orlando, Florida, United States, 32806
United States, Georgia
Savannah, Georgia, United States, 31406
United States, Louisiana
New Orleans, Louisiana, United States, 70115
United States, Michigan
Taylor, Michigan, United States, 48180
United States, Nebraska
Omaha, Nebraska, United States, 68198
United States, New York
Buffalo, New York, United States, 14215
Ithaca, New York, United States, 14850
United States, North Carolina
Greenville, North Carolina, United States, 27834
United States, Ohio
Columbus, Ohio, United States, 43210
Maumee, Ohio, United States, 43537
Toledo, Ohio, United States, 43614
United States, Oregon
Medford, Oregon, United States, 97504
United States, Rhode Island
Johnston, Rhode Island, United States, 02919
United States, South Carolina
Easley, South Carolina, United States, 29640
Gaffney, South Carolina, United States, 29340
Spartanburg, South Carolina, United States, 29303
Union, South Carolina, United States, 29379
United States, Texas
San Antonio, Texas, United States, 78212
United States, Virginia
Richmond, Virginia, United States, 23225
Salem, Virginia, United States, 24153
Sponsors and Collaborators
Horizon Pharma USA, Inc.
Investigators
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Principal Investigator: Sanjay Sethi, M.D. University at Buffalo
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Horizon Pharma USA, Inc.
ClinicalTrials.gov Identifier: NCT00739648    
Other Study ID Numbers: Mpex-302
First Posted: August 22, 2008    Key Record Dates
Results First Posted: March 2, 2012
Last Update Posted: January 19, 2018
Last Verified: January 2018
Keywords provided by Horizon Pharma USA, Inc.:
COPD
Patients
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Levofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
 Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors