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 |
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Recruitment Status :
Completed
First Posted : August 22, 2008
Results First Posted : March 2, 2012
Last Update Posted : January 19, 2018
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Sponsor:
Horizon Pharma USA, Inc.
Information provided by (Responsible Party):
Horizon Pharma USA, Inc.
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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 |
| 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
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: Placebo
same frequency as study drug using the same method of delivery
Other Name: MP-376 color-matched placebo |
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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
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Drug: MP-376
MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles
Other Names:
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Primary Outcome Measures :
- 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 :
- 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
- 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
- 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
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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
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
| 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
| Principal Investigator: | Sanjay Sethi, M.D. | University at Buffalo |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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.:
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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 |